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Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia (LGL)

Primary Purpose

Large Granular Lymphocytes Leukemia

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Methotrexate
Cyclophosphamide
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Large Granular Lymphocytes Leukemia focused on measuring large granular lymphocytes leukemia, immunosuppressive drugs, methotrexate, cyclophosphamide, efficiency, phase II randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Common criteria of LGL leukemia: the diagnosis is based on a chronic LGL peripheral blood expansion (>0.5x109/L), usually lasting more than 6 months

  • Specific criteria for T-LGL leukemia or NK-LGL lymphocytosis or chronic NK-LGL leukemia:

    • Specific criteria for T-LGL leukemia:
  • Expression of LGL surface markers compatible with an activated T-cell (commonly alpha-beta+/CD3+/CD8+/CD57+ and/or CD16+) phenotype or gamma-delta+ T cells;

  • Clonal rearrangement of TCRγ gene using PCR or specific and clonal Vβ expression using FCM.

    • Specific criteria for NK-LGL lymphocytosis or chronic NK LGL leukemia:
  • Expression of LGL surface markers compatible with a NK cell (commonly CD3-/CD8+/CD16+ and/or CD16+/CD56+) phenotype;
  • CD56+ or CD16+ NK cells greater than 0.75x109/L;
  • The term of chronic NK-LGL lymphocytosis is used for patients with chronic illness (NB: patients with massive tissue LGL infiltration of the spleen, liver and bone marrow and presenting aggressive clinical behavior are considered as having aggressive NK-LGL leukemia and should not be included).
  • Age above 18 years
  • ECOG performance status of 0-2
  • Life expectancy of at least 1 year
  • Lack of previous treatment (except with G-CSF or transfusions)

  • At least one indication of treatment:

    • Isolated severe neutropenia (ANC <0.5x109/L) or neutropenia (ANC <1.5x109/L) with two or more infections requiring antibiotics;
    • Anemia (whatever the underlying mechanism: pure red cell aplasia or marrow infiltration) requiring transfusions greater than 2 units for two months prior to inclusion, or symptomatic anemia (hemoglobin <10g/dl) with impairment of the quality of life;
    • Associated complications such as systemic diseases or auto-immune diseases (i.e. recurrent uveitis, cutaneous vasculitis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, rheumatoid arthritis resistant to steroids and/or immunomodulator agents (colchicin, disulone, hydrochloroquine)) and justifying a treatment with methotrexate or cyclophosphamide
  • Written informed consent

Exclusion Criteria:

  • Inability to understand or to follow study procedures
  • Prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Other serious medical illnesses, such as hepatic, renal, cardiac, pulmonary, neurologic, or metabolic disease that would preclude the patient's ability to tolerate methotrexate, cyclophosphamide, or ciclosporine A
  • Reactive LGL lymphocytosis (i.e. after viral infection)
  • ALAT/ASAT or alkalin phosphatases >3 times normal values
  • Creatinine clairance <50 ml/min
  • Serologic evidence of HIV, hepatitis C or hepatitis B infection
  • Non effective contraception
  • Positive pregnancy test
  • Nursing woman

Sites / Locations

  • CHU SudRecruiting
  • CHU AngersRecruiting
  • Intern medecine Service - CH Antibes-Juan-les-PinsRecruiting
  • Hematology Service - CH AvignonRecruiting
  • Hematology Service - CH de la cote basqueRecruiting
  • hematology service - CH BeauvaisRecruiting
  • Hematology Service - CH Jean MinjozRecruiting
  • Hematology Service - CH BeziersRecruiting
  • Hematology Unit - HOpital AvicienneRecruiting
  • Hematology Service - CH Docteur DuchenneRecruiting
  • Hematology Service - CH de BrestRecruiting
  • Hematology Service - CH François BaclesseRecruiting
  • hematology Service - CH Louis PasteurRecruiting
  • Centre Hospitalier de CholetRecruiting
  • Hopital Inter-Armées PercyRecruiting
  • hematology Service - CHU EstaingRecruiting
  • Hematology Service - Civils hospitalRecruiting
  • Hematology Service CHSFRecruiting
  • CHU Henri Mondor Lymphoid Hemopathy UnitRecruiting
  • Hematology Unit CH MichalonRecruiting
  • Hematology Unit CHD VendéeRecruiting
  • Hematology Unit CH LE MANSRecruiting
  • CH Robert BoulinRecruiting
  • Hematology Unit CHRU LilleRecruiting
  • Hematology Unit CHU DupuytrenRecruiting
  • CH de Bretagne SudRecruiting
  • Hematology Unit CHU La ConceptionRecruiting
  • Hematology Unit - Institut Paoli-CalmettesRecruiting
  • Hematology Unit CH MeauxRecruiting
  • Hematology Unit CH Notre Dame Bon SecoursRecruiting
  • Hematogy Unit CHU ST ELOIRecruiting
  • Hematology Unit CH E.MULLERRecruiting
  • Internal Medicine - CHU Hotel DieuRecruiting
  • Oncology Unit CH Antoine LacassagneRecruiting
  • hematology Unit CHU CaremeauRecruiting
  • Hematology Unit - CHR OrleansRecruiting
  • Hematology Service - Hopital La Pitié SalpetrièreRecruiting
  • Hematology Unit - Hopital Hotel DieuRecruiting
  • Hematology Unit - Hopital Saint AntoineRecruiting
  • AP-HP Hôpital Necker - Enfants MaladesRecruiting
  • Hematology Unit - Hopital Saint LouisRecruiting
  • Hematology Unit Hopital Saint JeanRecruiting
  • Hematology Service- CH Haut LevequeRecruiting
  • Hematology Unit CH LYON SUDRecruiting
  • Hematology Unit CHU La MiletrieRecruiting
  • Hematology Unit CH René DUBOSRecruiting
  • CH Annecy - Hematology ServiceRecruiting
  • Hematology Unit- Hopital Robert DebréRecruiting
  • Hematology Service - CHU of RennesRecruiting
  • Hematology Unit - CH BecquerelRecruiting
  • Oncology Unit - Institut de cancérologie de la LoireRecruiting
  • CH Saint Quentin OncohematologyRecruiting
  • CH Yves LefollRecruiting
  • Hematology Unit CHU ToulouseRecruiting
  • Hematology Unit CHU BretonneauRecruiting
  • Hematology Unit Hopitaux de BraboisRecruiting
  • Intern Medecine Unit CHBARecruiting
  • Hôpital André Mignot Centre Hospitalier de VersaillesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

METHOTREXATE

CYCLOPHOSPHAMIDE

Arm Description

In step 1, 55 patients will receive methotrexate 10mg / m² orally once a week, (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take In step 2, responders at Month 4 (CR or PR) will be treated during 8 additional months with methotrexate at the same dosage. Non responders at Month 4 will be randomized and treated either by: Cyclophosphamide delivered at 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take between Month 5 and Month 8, decreased to 50 mg orally once daily beyond Month 8 for responders at Month 8; Ciclosporine A delivered at 3 mg/kg per day (at split doses of 1.5 mg/kg in the morning and 1.5 mg/kg at night) orally administered.

In step 1, 55 patients will receive cyclophosphamide 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take. In step 2, responders at Month 4 (CR or PR) will be treated during 8 additional months with cyclophosphamide (at 50 mg orally once daily); Non responders at Month 4 will be randomized and treated either by: Methotrexate administered at 10 mg/m2 orally once a week (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take; Ciclosporine A delivered at 3 mg/kg per day (at split doses of 1.5 mg/kg in the morning and 1.5 mg/kg at night) orally administered.

Outcomes

Primary Outcome Measures

Complete response (CR)
The main endpoint will be the hematological CR rate evaluated after 4 months of treatment (binary endpoint). Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin >12g/dL, platelets >150x109/L, ANC >1.5x109/L), lymphocytosis <4x109/L and circulating LGL in the normal range (<0.3x109/L). The number of LGL will be quantitated on blood smears.

Secondary Outcome Measures

overall response rate (ORR)
Hematological overall response rate (ORR) defined as the sum of complete responses and partial responses over the total number of patients.
Complete response (CR)
Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin >12g/dL, platelets >150x109/L, ANC >1.5x109/L), lymphocytosis <4x109/L and circulating LGL in the normal range (<0.3x109/L). The number of LGL will be quantitated on blood smears.
Hematological partial response (PR)
Hematological partial response (PR) defined as an improvement in blood counts which do not meet criteria for complete remission (e.g., ANC increasing more than 50% and reaching more than 0.5 but less than 1.5x109/L with non-recurrence of infections, or hemoglobin level increasing more than 2 g/dL from baseline and transfusion requirements stopping without normalization of the hemoglobin level defined as hemoglobin >12g/dL).
Progressive disease
Progressive disease defined as worsening of cytopenia or organomegaly or incidence of infections.
Time-to-relapse
Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC <1x109/L and/or hemoglobin <10g/dL) or clonal LGL >0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests.
Time-to-relapse
Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC <1x109/L and/or hemoglobin <10g/dL) or clonal LGL >0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests.
Molecular remission
Molecular remission defined as the disappearance of the clonal pattern of TCR gamma multiplex rearrangement and Phenotypic remission is defined as : For the T subtype: disappearance of the excess of CD3+/CD8+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion); For the NK subtype: disappearance of the excess of CD3-/CD56+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion)
Adverse events rate
Adverse events rate
Compliance
Compliance
relationship between the response to treatment and the phenotypic subtype
Identification of a relationship between the response to treatment and the phenotypic subtype characterized by the panel of monoclonal antibodies defined in the ancillary study subsection.

Full Information

First Posted
October 22, 2013
Last Updated
September 13, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01976182
Brief Title
Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
Acronym
LGL
Official Title
Prospective, Sequential Multiple Assignment, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2013 (Actual)
Primary Completion Date
September 26, 2024 (Anticipated)
Study Completion Date
May 26, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
Detailed Description
Large Granular Lymphocyte (LGL) leukemia is a clonal disorder involving tissue invasion of marrow, spleen and liver. Clinical presentation is dominated by recurrent infections associated with neutropenia, anemia, splenomegaly, and auto-immune diseases, particularly rheumatoid arthritis. Both T cell and NK cell subtypes of LGL leukemia are indolent disease and considered as a chronic illness and lead to a treatment in more than 60% of patients. LGL leukemia displays a chronic clinical course. Recommendations regarding therapy are similar for both subtypes. Indications for treatment include 1) severe neutropenia (ANC <500 mm3); 2) neutropenia (ANC <1500mm3) with symptomatic recurrent infections; 3) symptomatic or transfusion-dependent anemia and 4) associated autoimmune conditions requiring therapy, most often rheumatoid arthritis. There is no standard treatment for patients with LGL leukemia. The numerous case reports published do not provide a consensus for a particular treatment. All the six largest series published in the literature so far (collecting data on more than 40 patients) are retrospective. Immunosuppressive therapy remains the foundation of treatment including single three agents i.e. methotrexate, oral cyclophosphamide and ciclosporin A. However prospective trials involving large numbers of patients have not been performed and no molecule has proven superiority over others. Invetigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. Combining the results of our series with those of the literature, invetigators estimate that overall response rate and complete response rate are 55% and 30% with methotrexate, 60% and 50% with cyclophosphamide, and 55% and less than 20% with ciclosporine A, respectively. Thus, there are four objective in this study : to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy to evaluate the response rate according to the phenotypic subtype of LGL leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large Granular Lymphocytes Leukemia
Keywords
large granular lymphocytes leukemia, immunosuppressive drugs, methotrexate, cyclophosphamide, efficiency, phase II randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
METHOTREXATE
Arm Type
Active Comparator
Arm Description
In step 1, 55 patients will receive methotrexate 10mg / m² orally once a week, (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take In step 2, responders at Month 4 (CR or PR) will be treated during 8 additional months with methotrexate at the same dosage. Non responders at Month 4 will be randomized and treated either by: Cyclophosphamide delivered at 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take between Month 5 and Month 8, decreased to 50 mg orally once daily beyond Month 8 for responders at Month 8; Ciclosporine A delivered at 3 mg/kg per day (at split doses of 1.5 mg/kg in the morning and 1.5 mg/kg at night) orally administered.
Arm Title
CYCLOPHOSPHAMIDE
Arm Type
Active Comparator
Arm Description
In step 1, 55 patients will receive cyclophosphamide 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take. In step 2, responders at Month 4 (CR or PR) will be treated during 8 additional months with cyclophosphamide (at 50 mg orally once daily); Non responders at Month 4 will be randomized and treated either by: Methotrexate administered at 10 mg/m2 orally once a week (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take; Ciclosporine A delivered at 3 mg/kg per day (at split doses of 1.5 mg/kg in the morning and 1.5 mg/kg at night) orally administered.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
methotrexate 10mg / m² orally once a week, (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take, during 4 months.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
cyclophosphamide 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take, during 4 months.
Primary Outcome Measure Information:
Title
Complete response (CR)
Description
The main endpoint will be the hematological CR rate evaluated after 4 months of treatment (binary endpoint). Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin >12g/dL, platelets >150x109/L, ANC >1.5x109/L), lymphocytosis <4x109/L and circulating LGL in the normal range (<0.3x109/L). The number of LGL will be quantitated on blood smears.
Time Frame
at Month 4
Secondary Outcome Measure Information:
Title
overall response rate (ORR)
Description
Hematological overall response rate (ORR) defined as the sum of complete responses and partial responses over the total number of patients.
Time Frame
at Month 4, and at Month 8 and Month 12 in non-responders at Month 4
Title
Complete response (CR)
Description
Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin >12g/dL, platelets >150x109/L, ANC >1.5x109/L), lymphocytosis <4x109/L and circulating LGL in the normal range (<0.3x109/L). The number of LGL will be quantitated on blood smears.
Time Frame
at Month 8 and Month 12
Title
Hematological partial response (PR)
Description
Hematological partial response (PR) defined as an improvement in blood counts which do not meet criteria for complete remission (e.g., ANC increasing more than 50% and reaching more than 0.5 but less than 1.5x109/L with non-recurrence of infections, or hemoglobin level increasing more than 2 g/dL from baseline and transfusion requirements stopping without normalization of the hemoglobin level defined as hemoglobin >12g/dL).
Time Frame
at Month 4, Month 8 and Month 12
Title
Progressive disease
Description
Progressive disease defined as worsening of cytopenia or organomegaly or incidence of infections.
Time Frame
at Month 4, Month 8 and Month 12
Title
Time-to-relapse
Description
Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC <1x109/L and/or hemoglobin <10g/dL) or clonal LGL >0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests.
Time Frame
from Month 4 to endpoint (in first-line treatment responders)
Title
Time-to-relapse
Description
Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC <1x109/L and/or hemoglobin <10g/dL) or clonal LGL >0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests.
Time Frame
from Month 8 to endpoint (in second-line treatment responders)
Title
Molecular remission
Description
Molecular remission defined as the disappearance of the clonal pattern of TCR gamma multiplex rearrangement and Phenotypic remission is defined as : For the T subtype: disappearance of the excess of CD3+/CD8+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion); For the NK subtype: disappearance of the excess of CD3-/CD56+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion)
Time Frame
at Month 4 and Month 12 for hematological complete responders
Title
Adverse events rate
Description
Adverse events rate
Time Frame
Month 2, Month 4, Month 6, Month 8, Month 10, Month 12
Title
Compliance
Description
Compliance
Time Frame
Month 2, Month 4, Month 6, Month 8, Month 10, Month 12
Title
relationship between the response to treatment and the phenotypic subtype
Description
Identification of a relationship between the response to treatment and the phenotypic subtype characterized by the panel of monoclonal antibodies defined in the ancillary study subsection.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Common criteria of LGL leukemia: the diagnosis is based on a chronic LGL peripheral blood expansion (>0.5x109/L), usually lasting more than 6 months Specific criteria for T-LGL leukemia or NK-LGL lymphocytosis or chronic NK-LGL leukemia: Specific criteria for T-LGL leukemia: Expression of LGL surface markers compatible with an activated T-cell (commonly alpha-beta+/CD3+/CD8+/CD57+ and/or CD16+) phenotype or gamma-delta+ T cells; Clonal rearrangement of TCRγ gene using PCR or specific and clonal Vβ expression using FCM. Specific criteria for NK-LGL lymphocytosis or chronic NK LGL leukemia: Expression of LGL surface markers compatible with a NK cell (commonly CD3-/CD8+/CD16+ and/or CD16+/CD56+) phenotype; CD56+ or CD16+ NK cells greater than 0.75x109/L; The term of chronic NK-LGL lymphocytosis is used for patients with chronic illness (NB: patients with massive tissue LGL infiltration of the spleen, liver and bone marrow and presenting aggressive clinical behavior are considered as having aggressive NK-LGL leukemia and should not be included). Age above 18 years ECOG performance status of 0-2 Life expectancy of at least 1 year Lack of previous treatment (except with G-CSF or transfusions) At least one indication of treatment: Isolated severe neutropenia (ANC <0.5x109/L) or neutropenia (ANC <1.5x109/L) with two or more infections requiring antibiotics; Anemia (whatever the underlying mechanism: pure red cell aplasia or marrow infiltration) requiring transfusions greater than 2 units for two months prior to inclusion, or symptomatic anemia (hemoglobin <10g/dl) with impairment of the quality of life; Associated complications such as systemic diseases or auto-immune diseases (i.e. recurrent uveitis, cutaneous vasculitis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, rheumatoid arthritis resistant to steroids and/or immunomodulator agents (colchicin, disulone, hydrochloroquine)) and justifying a treatment with methotrexate or cyclophosphamide Written informed consent Exclusion Criteria: Inability to understand or to follow study procedures Prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix Other serious medical illnesses, such as hepatic, renal, cardiac, pulmonary, neurologic, or metabolic disease that would preclude the patient's ability to tolerate methotrexate, cyclophosphamide, or ciclosporine A Reactive LGL lymphocytosis (i.e. after viral infection) ALAT/ASAT or alkalin phosphatases >3 times normal values Creatinine clairance <50 ml/min Serologic evidence of HIV, hepatitis C or hepatitis B infection Non effective contraception Positive pregnancy test Nursing woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Lamy, PUPH
Phone
02 99 28 42 91
Ext
+33
Email
thierry.lamy@chu-rennes.fr
Facility Information:
Facility Name
CHU Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre MAROLLEAU, MD
Phone
03 22 45 59 20
Ext
+33
Email
marolleau.jean-pierre@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Jean-Pierre MAROLLEAU, MD
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata truchand-Graczyk, MD
Phone
02 41 35 45 24
Ext
+33
Email
MaTruchan@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Malgorazata Truchand-Graczyk, MD
Facility Name
Intern medecine Service - CH Antibes-Juan-les-Pins
City
Antibes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel RE, MD
Phone
04 97 24 77 46
Ext
+33
Email
daniel.re@ch-antibes.fr
First Name & Middle Initial & Last Name & Degree
Daniel RE, MD
Facility Name
Hematology Service - CH Avignon
City
Avignon
ZIP/Postal Code
84902
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hacène ZERAZHI, MD
Phone
04 32 75 93 93
Ext
+33
Email
hzerazhi@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Zerazhi Hacène, MD
Facility Name
Hematology Service - CH de la cote basque
City
Bayonne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Banos, MD
Phone
05 59 44 38 32
Ext
+33
Email
abanos@ch-cotebasque.fr
First Name & Middle Initial & Last Name & Degree
Anne Banos, MD
Facility Name
hematology service - CH Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustapha Ghomari, MD
Phone
03 44 11 23 90
Ext
+33
Email
kamel.ghomari@ch-beauvais.fr
First Name & Middle Initial & Last Name & Degree
Mustapha Ghomari, MD
Facility Name
Hematology Service - CH Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie BRION, MD
Phone
03 81 66 82 32
Ext
+33
Email
abrion@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Annie BRION, MD
Facility Name
Hematology Service - CH Beziers
City
Beziers
ZIP/Postal Code
34500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain SAAD, MD
Phone
04 67 35 70 63
Ext
+33
Email
alain.saad@ch-beziers.fr
First Name & Middle Initial & Last Name & Degree
Alain SAAD, MD
Facility Name
Hematology Unit - HOpital Avicienne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Cymbalista, MD
Phone
01 48 95 56 40
Ext
+33
Email
florence.cymbalista@avc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Florence Cymbalista, MD
Facility Name
Hematology Service - CH Docteur Duchenne
City
Boulogne sur Mer
ZIP/Postal Code
62321
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand POLLET, MD
Phone
03 21 99 82 02
Ext
+33
Email
b.pollet@ch-boulogne.fr
First Name & Middle Initial & Last Name & Degree
Bertrand POLLET, MD
Facility Name
Hematology Service - CH de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hussam SAAD, MD
Phone
02 98 22 34 21
Ext
+33
Email
hussam.saad@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
hussam SAAD, MD
Facility Name
Hematology Service - CH François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre VILQUE, MD
Phone
02 31 45 50 12
Ext
+33
Email
jp.vilque@baclesse.fr
First Name & Middle Initial & Last Name & Degree
Jean-Pierre VILQUE, MD
Facility Name
hematology Service - CH Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel MICLEA, MD
Phone
02 37 30 30 77
Ext
+33
Email
jmmiclea@ch-chartres.fr
First Name & Middle Initial & Last Name & Degree
Jean Michel MICLEA, MD
Facility Name
Centre Hospitalier de Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Bescond, MD
Phone
02 41 49 84 91
Ext
+33
Email
charles.bescond@ch-cholet.fr
First Name & Middle Initial & Last Name & Degree
Charles Bescond, MD
Facility Name
Hopital Inter-Armées Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Valère MALFUSON, MD
Phone
01 41 46 63 01
Ext
+33
First Name & Middle Initial & Last Name & Degree
Jean-Valère MALFUSON, MD
Facility Name
hematology Service - CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Tournilhac, MD
Phone
04 73 75 00 65
Ext
+33
Email
otournilhac@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Joel Fleury, MD
First Name & Middle Initial & Last Name & Degree
Olivier Tournilhac, MD
Facility Name
Hematology Service - Civils hospital
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Belkaid, MD
Phone
03 89 12 43 29
Ext
+33
Email
mohammed.belkaid@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
Mohammed BELKAID, MD
Facility Name
Hematology Service CHSF
City
Corbeil Essonnes
ZIP/Postal Code
91110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Célia SALANOUBAT, MD
Phone
01 60 90 31 78
Ext
+33
Email
celia.salanoubat@ch-sud-francilien.fr
First Name & Middle Initial & Last Name & Degree
Célia SALANOUBAT, MD
Facility Name
CHU Henri Mondor Lymphoid Hemopathy Unit
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jehan DUPUIS, MD
Phone
01 49 81 41 74
Ext
+33
Email
jehan.dupuis@hmn.aphp.fr
First Name & Middle Initial & Last Name & Degree
Jehan DUPUIS, MD
First Name & Middle Initial & Last Name & Degree
Marc MICHEL, MD
Facility Name
Hematology Unit CH Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lysiane MOLINA, MD
Phone
04 76 76 76 69
Ext
+33
Email
lmolina@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Lysiane Molina, MD
Facility Name
Hematology Unit CHD Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mourad TIAB, MD
Phone
02 51 44 61 73
Ext
+33
Email
mourad.tiab@chd.vendee.fr
First Name & Middle Initial & Last Name & Degree
Mourad TIAB, MD
Facility Name
Hematology Unit CH LE MANS
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamel Laribi, MD
Phone
02 43 43 29 59
Ext
+33
Email
klaribi@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Kamel Laribi, MD
Facility Name
CH Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëlle Laboure, MD
Phone
05 57 55 26 17
Ext
+33
Email
gaelle.laboure@ch-libourne.fr
First Name & Middle Initial & Last Name & Degree
Gaëlle Laboure, MD
Facility Name
Hematology Unit CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis TERRIOU, MD
Phone
03 20 44 42 90
Ext
+33
Email
louis.terriou@free.fr
First Name & Middle Initial & Last Name & Degree
Louis TERRIOU, MD
Facility Name
Hematology Unit CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Jaccard, MD
Phone
05 55 05 66 51
Ext
+33
Email
arnaud.jaccard@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Arnaud Jaccard, MD
Facility Name
CH de Bretagne Sud
City
Lorient
ZIP/Postal Code
56322
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien TREBOUET, MD
First Name & Middle Initial & Last Name & Degree
Adrien TREBOUET, MD
Facility Name
Hematology Unit CHU La Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regis Costello, MD
Phone
04 91 38 41 50
Ext
+33
Email
regis.costello@free.fr
First Name & Middle Initial & Last Name & Degree
Regis Costello, MD
Facility Name
Hematology Unit - Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thérèse Aurran-Schleinitz, MD
Phone
04 91 22 38 66
Ext
+33
Email
aurrant@marseille.fnclcc.fr
First Name & Middle Initial & Last Name & Degree
Thérèse Aurran-Schleinitz, MD
First Name & Middle Initial & Last Name & Degree
Jérome REY, MD
Facility Name
Hematology Unit CH Meaux
City
Meaux
ZIP/Postal Code
77100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajed Abarah, MD
Phone
01 64 35 38 75
Ext
+33
Email
w-abarah@ch-meaux.fr
First Name & Middle Initial & Last Name & Degree
Wajed Abarah, MD
Facility Name
Hematology Unit CH Notre Dame Bon Secours
City
Metz
ZIP/Postal Code
57000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe CARASSOU, MD
Phone
03 87 55 32 32
Ext
+33
Email
p.carassou@chr-metz-thionville.fr
First Name & Middle Initial & Last Name & Degree
Philippe CARASSOU, MD
Facility Name
Hematogy Unit CHU ST ELOI
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume CARTRON, MD
Phone
04 67 33 83 62
Ext
+33
Email
g-cartron@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Guillaume CARTRON, MD
Facility Name
Hematology Unit CH E.MULLER
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard DRENOU, MD
Phone
03 89 64 77 85
Ext
+33
Email
drenoub@ch-mulhouse.fr
First Name & Middle Initial & Last Name & Degree
Bernard DRENOU, MD
Facility Name
Internal Medicine - CHU Hotel Dieu
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine NEEL, MD
Email
antoine.neel@chu-nantes.fr
Facility Name
Oncology Unit CH Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel RE, MD
Phone
04 92 03 16 18
Ext
+33
Email
daniel.re@ch-antibes.fr
First Name & Middle Initial & Last Name & Degree
Daniel RE, MD
Facility Name
hematology Unit CHU Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric JOURDAN, MD
Phone
04 66 68 32 31
Ext
+33
Email
eric.jourdan@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Eric Jourdan, MD
Facility Name
Hematology Unit - CHR Orleans
City
Orleans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magda ALEXIS, MD
Phone
02 38 22 95 47
Ext
+33
Email
magda.alexis@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Magda ALEXIS, MD
Facility Name
Hematology Service - Hopital La Pitié Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique LEBLOND, MD
Phone
01 42 16 28 24
Ext
+33
Email
veronique.leblond@psl.aphp.fr
First Name & Middle Initial & Last Name & Degree
Véronique LEBLOND, MD
First Name & Middle Initial & Last Name & Degree
Sylvain CHOQUET, MD
Facility Name
Hematology Unit - Hopital Hotel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DREYFUS, MD
Phone
01 42 34 87 65
Ext
+33
Email
francois.dreyfus@cch.aphp.fr
First Name & Middle Initial & Last Name & Degree
François DREYFUS, MD
Facility Name
Hematology Unit - Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne VEKHOFF, MD
Phone
01 49 28 34 29
Ext
+33
Email
anne-vekhoff@sat.aphp.fr
First Name & Middle Initial & Last Name & Degree
Anne VEKHOFF, MD
Facility Name
AP-HP Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Hermine, MD
First Name & Middle Initial & Last Name & Degree
Richard Delarue, MD
Facility Name
Hematology Unit - Hopital Saint Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion MALPHETTES, MD
Phone
01 42 49 92 97
Ext
+33
First Name & Middle Initial & Last Name & Degree
Marion MALPHETTES, MD
Facility Name
Hematology Unit Hopital Saint Jean
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence SANHES, MD
Phone
04 68 61 64 48
Ext
+33
Email
laurence.sanhes@ch-perpignan.fr
First Name & Middle Initial & Last Name & Degree
Laurence SANHES, MD
Facility Name
Hematology Service- CH Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Sarah Dilhuydy, MD
Phone
05 57 65 65 11
Ext
+33
Email
marie-sarah.dilhuydy@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Marie-Sarah DILHUYDY, MD
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, PUPH
Facility Name
Hematology Unit CH LYON SUD
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Lazareth, MD
Phone
04 78 86 43 09
Ext
+33
Email
anne.lazareth@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Anne Lazareth, MD
Facility Name
Hematology Unit CHU La Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile TOMOWIAC, MD
Phone
05 49 44 43 07
Ext
+33
Email
c.tomowiac@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Cécile TOMOWIAC, MD
Facility Name
Hematology Unit CH René DUBOS
City
Pontoise
ZIP/Postal Code
95000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo GONZALEZ, MD
Phone
01 30 75 47 35
Ext
+33
Email
hugo.gonzalez@ch-pontoise.fr
First Name & Middle Initial & Last Name & Degree
Hugo GONZALEZ, MD
Facility Name
CH Annecy - Hematology Service
City
Pringy
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédérique orsini-piocelle, MD
Phone
04 50 63 66 08
Ext
+33
Email
forsinipiocelle@ch-annecy.fr
First Name & Middle Initial & Last Name & Degree
Frédérique Orsini-Piocelle, MD
Facility Name
Hematology Unit- Hopital Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain DELMER, MD
Phone
03 26 78 36 44
Ext
+33
Email
adelmer@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Alain DELMER, MD
Facility Name
Hematology Service - CHU of Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Lamy, PUPH
Phone
02 99 28 42 91
Ext
+33
Email
thierry.lamy@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Thierry Lamy, PUPH
Facility Name
Hematology Unit - CH Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane LEPETRE, MD
Phone
02 32 08 22 23
Ext
+33
Email
stelep@rouen.fnclcc.fr
First Name & Middle Initial & Last Name & Degree
Stéphane LEPETRE, MD
Facility Name
Oncology Unit - Institut de cancérologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
60008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine AUGEUL-MEUNIER, MD
Phone
04 77 91 70 60
Ext
+33
Email
karine.augeul-meunier@icloire.fr
First Name & Middle Initial & Last Name & Degree
Karine AUGEUL-MEUNIER, MD
Facility Name
CH Saint Quentin Oncohematology
City
Saint Quentin
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reda GARIDI, MD
Phone
03 23 06 78 61
Ext
+33
Email
r.garidi@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
Reda GARIDI, MD
Facility Name
CH Yves Lefoll
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent LAUNAY, MD
First Name & Middle Initial & Last Name & Degree
Vincent LAUNAY, MD
Facility Name
Hematology Unit CHU Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loic YSEBAERT, MD
Phone
05 61 77 76 68
Ext
+33
Email
ysebaert.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Loic YSEBEART, MD
First Name & Middle Initial & Last Name & Degree
Daniel ADOUE, PUPH
Facility Name
Hematology Unit CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DARTIGAS, MD
Phone
02 47 47 37 12
Ext
+33
Email
c.dartigeas@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Caroline DARTIGAS, MD
Facility Name
Hematology Unit Hopitaux de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, MD
Phone
03 83 15 32 82
Ext
+33
Email
p.feugier@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, MD
Facility Name
Intern Medecine Unit CHBA
City
Vannes
ZIP/Postal Code
56017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal GODMER, MD
Phone
02 97 01 41 45
Ext
+33
Email
pascal.godmer@ch-bretagne-atlantique.fr
First Name & Middle Initial & Last Name & Degree
Pascal GODMER, MD
Facility Name
Hôpital André Mignot Centre Hospitalier de Versailles
City
Versailles
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Kohn, MD
Email
mikohn@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Milena Kohn, MD

12. IPD Sharing Statement

Learn more about this trial

Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

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