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Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL

Primary Purpose

Relapsed Angioimmunoblastic T-Cell Lymphoma, Refractory Angioimmunoblastic T-cell Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral azacitidine
Romidepsin
Bendamustine
Gemcitabine
Sponsored by
The Lymphoma Academic Research Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Angioimmunoblastic T-Cell Lymphoma focused on measuring oral azacitidine

Eligibility Criteria

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

Inclusion Criteria:

Patients must satisfy all following criteria to be enrolled in the study::

  1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
  3. Patient is willing and able to adhere to the study visit schedule and other protocol requirements
  4. Patient had local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest World Health Organization (WHO) classification based on a surgical lymph node biopsy including any one of

    • Angioimmunoblastic T cell lymphoma (AITL)
    • Follicular T cell lymphoma
    • Nodal peripheral T-cell lymphoma with TFH phenotype There should be a documented expression of minimum two TFH markers among this panel of markers : CD10, CXCL13, PD1, ICOS and BCL6 by the tumoral cells by immunohistochemistry. Biopsy at relapse or progression is not mandatory, but highly encouraged on a surgical or needle core biopsy, and diagnostic tissue should be available for central pathology review and for ancillary molecular studies.

    Local pathology report should be reviewed by the sponsor's medical monitor prior to enrollment.

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
  6. Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.)
  7. Meet the following lab criteria:

    • Absolute Neutrophil Count (ANC) ≥ 1,5 x 109/L (≥ 1 x 109/L if bone marrow (BM) involvement by lymphoma)
    • Platelet ≥ 75 x 109/L (≥ 50 x 109/L if BM involvement by lymphoma)
    • Hemoglobin ≥ 8 g/dL.
  8. Anticipated life expectancy at least 3 months
  9. At least one measurable lesion on CT that is greater than 1.5 cm in the longest diameter for nodal lesions and greater than 1.0 cm in the longest diameter for extranodal lesions. The lesion must be measurable in two perpendicular dimensions. Patients with only cutaneous disease will be excluded.
  10. Female patient of childbearing potential (FCBP) may participate, providing she meets the following conditions:

    Have two negative pregnancy tests as verified by the investigator prior to starting study treatment: serum pregnancy test at Screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with study treatment (Cycle 1 Day 1). She must agree to ongoing pregnancy testing during the study (before beginning each subsequent cycle of treatment), and 28 days after the last study drug administration. This applies even if the patient practices complete abstinence from heterosexual contact.

    Agrees to practice true abstinence (which must be reviewed monthly and source documented) or agrees to the use of highly effective methods of contraception from 28 days prior to starting study treatment, and must agree to continue using such precautions during study treatment (including dose interruptions) and for up to 90 days after the last study drug administration. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptom-thermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. Cessation of contraception after this point should be discussed with a responsible physician.

    Agrees to abstain from breastfeeding during study participation and for at least 90 days after the last study drug administration.

    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).

  11. Male patient must either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agrees to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy), from starting dose of drug (cycle 1 Day 1), including dose interruptions through 90 days after receipt of the last study drug administration. Furthermore, male patient must agree to not give semen or sperm during study drug therapy and for a period of 1 year after end of study drug therapy.
  12. For EU countries, patient covered by a social security system

Exclusion Criteria:

Presence of any of the following will exclude a patient from enrollment:

  1. Clinical evidence of central nervous system involvement by lymphoma. Patients with suspicion of central nervous system (CNS) involvement must undergo neurologic evaluation and CT/MRI of head and lumbar puncture to exclude CNS disease.
  2. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
  3. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
  4. Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of positive HTLV1 serology or of active Hepatitis B (HB) Virus (HBV) infection defined as:

    • HB s Ag positive
    • HB s Ag negative, anti-HB s antibody positive and/or anti-HB c antibody positive with detectable viral DNA
  5. Impaired renal function (MDRD formula or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (Serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) > 3 upper normal limits) unless they are related to the lymphoma.
  6. Active malignancy other than the one treated in this research. Prior history of malignancies, other than low risk MDS or chronic myelomonocytic leukemia (CMML) (with less than 5% blasts in bone marrow), unless the patient has been free of the disease for ≥ 3 years. However, patients with the following history/concurrent conditions are allowed:

    1. Basal or squamous cell carcinoma of the skin
    2. Carcinoma in situ of the cervix
    3. Carcinoma in situ of the breast
    4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor-nodes-metastasis (TNM)] clinical staging system
    5. Early-stage gastric cancer suitable for endoscopic mucosal resection or endoscopic submucosal dissection
  7. Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study. Ongoing medically significant adverse events from previous treatment, regardless of the time period.
  8. Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine)
  9. Prior exposure to planned study treatment investigator's choice therapy (eg, prior exposure to gemcitabine is an exclusion if gemcitabine is the investigator's choice therapy prior to randomization)
  10. Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for ≥ 1 week prior to informed consent form signature
  11. Knowing or suspected hypersensitivity to active substance or to any of the excipients.
  12. Pregnant, planning to become pregnant, or lactating woman
  13. Candidate for hematopoietic stem cell transplantation
  14. History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator's decision. Any condition causing inability to swallow tablets.
  15. Significant active cardiac disease within the previous 6 months, including:

    • New York Heart Association (NYHA) class IV congestive heart failure
    • Unstable angina or angina requiring surgical or medical intervention; and/or
    • Myocardial infarction
  16. Person deprived of his/her liberty by a judicial or administrative decision
  17. Adult person under legal protection

Sites / Locations

  • University Hospital for Internal Medicine - University Hospital Graz
  • Medical University of Vienna
  • A. Z. Sint-Jan Brugge-Oostende AV
  • Cliniques Universitaires de Bruxelles - Hôpital Erasme
  • CHU UCL Namur - Site Godinne
  • Aarhus University Hospital
  • Institut d'Hématologie de Basse Normandie
  • CHU de Clermont-Ferrand - Hôpital Estaing
  • CHU Henri Mondor
  • CHU de Dijon
  • CHU de Grenoble
  • CHRU de Lille
  • CHU de Montpellier - Hôpital Saint-Eloi
  • CHU de Nantes - Hôtel Dieu
  • Hôpital Necker
  • Hôpital Saint-Louis
  • CHU Haut-Lévèque - Centre François Magendie
  • CHU Lyon-Sud
  • CH Annecy Genevois
  • CHU Pontchaillou
  • Centre Henri Becquerel
  • IUCT - Oncopole
  • CHRU de Nancy - Hôpital de Brabois
  • University College London Hospital
  • The Christie
  • Nottingham City Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Azacitidine

Investigator's choice therapy

Arm Description

Oral azacitidine 300mg during 14 first days of 28-days cycle for European (EU) patients, Oral azacitidine 200mg during 14 first days of 28-days cycle for Asian patients (Treatment until progression, patient decision or toxicity)

Romidepsin 14mg/m² on days 1, 8 and 15 of a 28-days cycle (Treatment until progression, patient decision or toxicity) or Bendamustine 120mg/m² on days 1 and 2 of a 21-days cycle (during 6 cycles) or Gemcitabine 1200mg/m² on days 1, 8 and 15 of a 28-days cycle (during 6 cycles)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
Progression Free Survival (PFS)
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)

Secondary Outcome Measures

Overall survival (OS)
Overall survival
PFS by the Independent Review Committee (IRC)
PFS by the Independent Review Committee
Overall response rate
Percentage of Complete Response (CR)+ Partial Response (PR) among all patients
Complete response rate (CRR)
Percentage of CR among all patients
Duration of response (DoR)
Duration of response
Time to response (TtR)
Time to response
PFS 2 using local assessment of progressive disease
PFS 2 using local assessment of progressive disease
Quality of Life Questionnaire (QLQ-C30)
questionnaire at baseline and at least one follow-up
Number of Serious Adverse Events (SAE)
Treatment discontinuation, adverse events, deaths

Full Information

First Posted
July 6, 2018
Last Updated
March 28, 2023
Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03593018
Brief Title
Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL
Official Title
Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Celgene

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
Detailed Description
Compared to B-cell Non-Hodgin Lymphoma (NHL), Angioimmunoblastic T-cell Lymphoma (AITL) is more resistant to conventional chemotherapy and is generally associated with an inferior outcome. In case of relapsed of refractory disease, survival durations are in the range of only a few months. Several agents have been evaluated in this setting in recent years: romidepsin, bendamustine or belinostat. The response rate with these agents rarely exceeds 30% and responses are usually of limited duration. Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with various myelodysplastic syndrome (MDS) subtypes. In this case, azacitidine significantly increase the survival time compared to standard of care option. This response to azacitidine could be correlated to the existence of recurrent mutations and those mutations have also been described in AITL. The present protocol will use Azacitidine according to the same schedule than in MDS that is continuous treatment until progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Angioimmunoblastic T-Cell Lymphoma, Refractory Angioimmunoblastic T-cell Lymphoma
Keywords
oral azacitidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Azacitidine
Arm Type
Experimental
Arm Description
Oral azacitidine 300mg during 14 first days of 28-days cycle for European (EU) patients, Oral azacitidine 200mg during 14 first days of 28-days cycle for Asian patients (Treatment until progression, patient decision or toxicity)
Arm Title
Investigator's choice therapy
Arm Type
Active Comparator
Arm Description
Romidepsin 14mg/m² on days 1, 8 and 15 of a 28-days cycle (Treatment until progression, patient decision or toxicity) or Bendamustine 120mg/m² on days 1 and 2 of a 21-days cycle (during 6 cycles) or Gemcitabine 1200mg/m² on days 1, 8 and 15 of a 28-days cycle (during 6 cycles)
Intervention Type
Drug
Intervention Name(s)
Oral azacitidine
Other Intervention Name(s)
CC-486
Intervention Description
Azacitidine tablets
Intervention Type
Drug
Intervention Name(s)
Romidepsin
Other Intervention Name(s)
Istodax
Intervention Description
Romidepsin injection
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Levact
Intervention Description
Bendamustine injection
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine injection
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
Time Frame
18 months after first randomisation (when 18 events will occur)
Title
Progression Free Survival (PFS)
Description
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
Time Frame
35 months after first randomisation (when 61 events will occur)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
PFS by the Independent Review Committee (IRC)
Description
PFS by the Independent Review Committee
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
Overall response rate
Description
Percentage of Complete Response (CR)+ Partial Response (PR) among all patients
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
Complete response rate (CRR)
Description
Percentage of CR among all patients
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
Duration of response (DoR)
Description
Duration of response
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
Time to response (TtR)
Description
Time to response
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
PFS 2 using local assessment of progressive disease
Description
PFS 2 using local assessment of progressive disease
Time Frame
40 months after first randomisation (when 57 deaths will occur) or 2 years after last randomisation
Title
Quality of Life Questionnaire (QLQ-C30)
Description
questionnaire at baseline and at least one follow-up
Time Frame
2 years after last randomisation
Title
Number of Serious Adverse Events (SAE)
Description
Treatment discontinuation, adverse events, deaths
Time Frame
2 years after last randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must satisfy all following criteria to be enrolled in the study:: Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted. Patient is willing and able to adhere to the study visit schedule and other protocol requirements Patient had local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest World Health Organization (WHO) classification based on a surgical lymph node biopsy including any one of Angioimmunoblastic T cell lymphoma (AITL) Follicular T cell lymphoma Nodal peripheral T-cell lymphoma with TFH phenotype There should be a documented expression of minimum two TFH markers among this panel of markers : CD10, CXCL13, PD1, ICOS and BCL6 by the tumoral cells by immunohistochemistry. Biopsy at relapse or progression is not mandatory, but highly encouraged on a surgical or needle core biopsy, and diagnostic tissue should be available for central pathology review and for ancillary molecular studies. Local pathology report should be reviewed by the sponsor's medical monitor prior to enrollment. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.) Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 109/L (≥ 1 x 109/L if bone marrow (BM) involvement by lymphoma) Platelet ≥ 75 x 109/L (≥ 50 x 109/L if BM involvement by lymphoma) Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months At least one measurable lesion on CT that is greater than 1.5 cm in the longest diameter for nodal lesions and greater than 1.0 cm in the longest diameter for extranodal lesions. The lesion must be measurable in two perpendicular dimensions. Patients with only cutaneous disease will be excluded. Female patient of childbearing potential (FCBP) may participate, providing she meets the following conditions: Have two negative pregnancy tests as verified by the investigator prior to starting study treatment: serum pregnancy test at Screening and negative serum or urine pregnancy test (investigator's discretion) within 72 hours prior to starting treatment with study treatment (Cycle 1 Day 1). She must agree to ongoing pregnancy testing during the study (before beginning each subsequent cycle of treatment), and 28 days after the last study drug administration. This applies even if the patient practices complete abstinence from heterosexual contact. Agrees to practice true abstinence (which must be reviewed monthly and source documented) or agrees to the use of highly effective methods of contraception from 28 days prior to starting study treatment, and must agree to continue using such precautions during study treatment (including dose interruptions) and for up to 90 days after the last study drug administration. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptom-thermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. Cessation of contraception after this point should be discussed with a responsible physician. Agrees to abstain from breastfeeding during study participation and for at least 90 days after the last study drug administration. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months). Male patient must either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agrees to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy), from starting dose of drug (cycle 1 Day 1), including dose interruptions through 90 days after receipt of the last study drug administration. Furthermore, male patient must agree to not give semen or sperm during study drug therapy and for a period of 1 year after end of study drug therapy. For EU countries, patient covered by a social security system Exclusion Criteria: Presence of any of the following will exclude a patient from enrollment: Clinical evidence of central nervous system involvement by lymphoma. Patients with suspicion of central nervous system (CNS) involvement must undergo neurologic evaluation and CT/MRI of head and lumbar puncture to exclude CNS disease. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision) Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment) Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of positive HTLV1 serology or of active Hepatitis B (HB) Virus (HBV) infection defined as: HB s Ag positive HB s Ag negative, anti-HB s antibody positive and/or anti-HB c antibody positive with detectable viral DNA Impaired renal function (MDRD formula or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (Serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) > 3 upper normal limits) unless they are related to the lymphoma. Active malignancy other than the one treated in this research. Prior history of malignancies, other than low risk MDS or chronic myelomonocytic leukemia (CMML) (with less than 5% blasts in bone marrow), unless the patient has been free of the disease for ≥ 3 years. However, patients with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor-nodes-metastasis (TNM)] clinical staging system Early-stage gastric cancer suitable for endoscopic mucosal resection or endoscopic submucosal dissection Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study. Ongoing medically significant adverse events from previous treatment, regardless of the time period. Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine) Prior exposure to planned study treatment investigator's choice therapy (eg, prior exposure to gemcitabine is an exclusion if gemcitabine is the investigator's choice therapy prior to randomization) Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for ≥ 1 week prior to informed consent form signature Knowing or suspected hypersensitivity to active substance or to any of the excipients. Pregnant, planning to become pregnant, or lactating woman Candidate for hematopoietic stem cell transplantation History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator's decision. Any condition causing inability to swallow tablets. Significant active cardiac disease within the previous 6 months, including: New York Heart Association (NYHA) class IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention; and/or Myocardial infarction Person deprived of his/her liberty by a judicial or administrative decision Adult person under legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jehan DUPUIS, MD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
François LEMONNIER, MD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kunihiro TSUKASAKI, MD
Organizational Affiliation
Saitama Medical University International Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital for Internal Medicine - University Hospital Graz
City
Graz
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
A. Z. Sint-Jan Brugge-Oostende AV
City
Bruges
Country
Belgium
Facility Name
Cliniques Universitaires de Bruxelles - Hôpital Erasme
City
Bruxelles
Country
Belgium
Facility Name
CHU UCL Namur - Site Godinne
City
Yvoir
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Institut d'Hématologie de Basse Normandie
City
Caen
Country
France
Facility Name
CHU de Clermont-Ferrand - Hôpital Estaing
City
Clermont-Ferrand
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
CHU de Montpellier - Hôpital Saint-Eloi
City
Montpellier
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
Country
France
Facility Name
Hôpital Necker
City
Paris
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
CHU Haut-Lévèque - Centre François Magendie
City
Pessac
Country
France
Facility Name
CHU Lyon-Sud
City
Pierre-Bénite
Country
France
Facility Name
CH Annecy Genevois
City
Pringy
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
IUCT - Oncopole
City
Toulouse
Country
France
Facility Name
CHRU de Nancy - Hôpital de Brabois
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Facility Name
The Christie
City
Manchester
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.lysarc.org/
Description
Website of The Lymphoma Study Research Organisation (LYSARC)

Learn more about this trial

Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL

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