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Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning

Primary Purpose

Graft Versus Host Disease

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Alemtuzumab
Sponsored by
CABYC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Myeloid and Lymphoid malignances

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients with haematological or lymphoid malignancies with allogenic transplantation indication:

    • High risk follicular NHL, mantle HHC and other low grade NHC (e.g lymphoplasmacytic, extranodal or from marginal zone).

      1. Disease that does not obtain a CR with Fludarabine or antiCD-20 including chemotherapy.
      2. Relapse after autologous transplant.
      3. Non candidates to autologous transplant in 2nd CR (e.g. mobilization failure, or persistent marrow infiltrate).
    • Poor prognosis chronic lymphoblastic leukaemia (CLL): Del 11q, Del 17p, complex cariotype; B symptoms, progressive low cell count by marrow infiltration, lymphocytosis or enlarged lymph nodes, or progressive spleen growth.
    • High grade lymphoma transformed from a low grade non Hodgkin's lymphoma or from a chronic lymphocitic leukaemia
    • High risk T peripheral lymphoma, with IPI > or = 2, non susceptible of autologous transplant, or relapsed after autologous transplant
    • Primarily refractory high risk Hodgkin's disease, relapse in patients not susceptible of autologous transplant or relapse after autologous transplant.
    • High risk acute mieloblastic leukaemia (AML) in 1st CR, or AMC > or = 2 CR, including AML after MDS and secondary AML.
    • High risk acute lymphoblastic leukaemia (ALL) because of poor response to induction chemotherapy (>10% blasts day +14 or no RC day +28-35), or by cytogenetic criteria: Ph+ or 11q23.
    • High risk myelodisplastic syndromes (SMD) type RAEB-1 or AREB-2 with IPSS >Int-1.
  • For the inclusion in transplant patients with ALL or AML must be in CR, patients with MDS must have <10% blasts en la BM, and patients with lymphoid malignancies must show previous chemosensitivity, with PR or CR.
  • Patients 40 to 65 years old. Patients outside this age range could be included according to participating centres criteria.
  • Patients in the study population lacking a compatible related donor, and with a possible compatible unrelated donor (>=9/10 by 10 alleles high resolution typing: HLA-A, B, C, DRB1, DQB1) to assign the patients to a risk in subgroup.
  • Signed informed consent.
  • Not fulfilling any of the following exclusion criteria.

Exclusion Criteria:

  • Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO & FVC <40% of expected) function tests impairment.
  • HIV injection.
  • Absence of signed informed consent.
  • Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
  • Other co-morbidities that contraindicate CT.
  • Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception.
  • Life expectancy <6 months.
  • Mental or psychiatric deficiency impeding adequate understanding and consent to therapy
  • Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial.
  • Active infectious process.

Sites / Locations

  • Hospital Germans Trias i Pujol
  • ICO Bellvitge
  • Hospital Clinic i Provincial.
  • Hospital Clinico de Valencia
  • Hospital Santa Creu i Sant Pau
  • Vall de Hebron
  • Hospital La Princesa
  • Hospital Gregorio Marañon
  • Hospital Ramón y Cajal
  • Hospital Morales Meseguer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

High risk patients (at least one GVHD high risk criterion): Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive).

Low Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).

Outcomes

Primary Outcome Measures

Analyze the results of incidence and severity of acute and chronic GVHD

Secondary Outcome Measures

Full Information

First Posted
October 28, 2008
Last Updated
February 3, 2015
Sponsor
CABYC
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT00781781
Brief Title
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning
Official Title
Multicenter, Openlabel, Phase II Intergroups (GELTAMO/GETH) Trial, on the Use of Alemtuzumab for Unrelated Donor Reduced Intensity Conditioning Allogenic Transplant in Hematological Malignancies Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit the number of patients established in the study protocol (34 of 40)
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CABYC
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.
Detailed Description
Each patient will be assigned to one of the two dosing schedules and total dose of drug envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath) dose will be done depending on the age and risk of suffering GVHD, in function of variables coming from general experience. High risk of GVHD criteria: Gender incompatibility: male patient of female donor. HLA incompatibility: non identical high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high resolution) Age of patient more or equal than 55 years Conventional doses in high risk (at least one criterion of GVHD high risk): 100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4. Reduced dose in low risk cases (no criteria of GVHD high risk): 50 mg de Alemtuzumab IV total dose en 5 fractions of 10 mg, days -5, -4, -3, -2 and -1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
Myeloid and Lymphoid malignances

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
High risk patients (at least one GVHD high risk criterion): Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive).
Arm Title
2
Arm Type
Experimental
Arm Description
Low Risk patients (no GVHD high risk criterion): Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Other Intervention Name(s)
MabCampath
Intervention Description
High risk: Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive) Low risk: Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
Primary Outcome Measure Information:
Title
Analyze the results of incidence and severity of acute and chronic GVHD
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with haematological or lymphoid malignancies with allogenic transplantation indication: High risk follicular NHL, mantle HHC and other low grade NHC (e.g lymphoplasmacytic, extranodal or from marginal zone). Disease that does not obtain a CR with Fludarabine or antiCD-20 including chemotherapy. Relapse after autologous transplant. Non candidates to autologous transplant in 2nd CR (e.g. mobilization failure, or persistent marrow infiltrate). Poor prognosis chronic lymphoblastic leukaemia (CLL): Del 11q, Del 17p, complex cariotype; B symptoms, progressive low cell count by marrow infiltration, lymphocytosis or enlarged lymph nodes, or progressive spleen growth. High grade lymphoma transformed from a low grade non Hodgkin's lymphoma or from a chronic lymphocitic leukaemia High risk T peripheral lymphoma, with IPI > or = 2, non susceptible of autologous transplant, or relapsed after autologous transplant Primarily refractory high risk Hodgkin's disease, relapse in patients not susceptible of autologous transplant or relapse after autologous transplant. High risk acute mieloblastic leukaemia (AML) in 1st CR, or AMC > or = 2 CR, including AML after MDS and secondary AML. High risk acute lymphoblastic leukaemia (ALL) because of poor response to induction chemotherapy (>10% blasts day +14 or no RC day +28-35), or by cytogenetic criteria: Ph+ or 11q23. High risk myelodisplastic syndromes (SMD) type RAEB-1 or AREB-2 with IPSS >Int-1. For the inclusion in transplant patients with ALL or AML must be in CR, patients with MDS must have <10% blasts en la BM, and patients with lymphoid malignancies must show previous chemosensitivity, with PR or CR. Patients 40 to 65 years old. Patients outside this age range could be included according to participating centres criteria. Patients in the study population lacking a compatible related donor, and with a possible compatible unrelated donor (>=9/10 by 10 alleles high resolution typing: HLA-A, B, C, DRB1, DQB1) to assign the patients to a risk in subgroup. Signed informed consent. Not fulfilling any of the following exclusion criteria. Exclusion Criteria: Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO & FVC <40% of expected) function tests impairment. HIV injection. Absence of signed informed consent. Progressive disease previous to transplant or not fulfilling the above mentioned response criteria. Other co-morbidities that contraindicate CT. Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception. Life expectancy <6 months. Mental or psychiatric deficiency impeding adequate understanding and consent to therapy Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial. Active infectious process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Duarte, MD, Ph.D
Organizational Affiliation
ICO Bellvitge. Hospital Duran i Reynals
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
ICO Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic i Provincial.
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Vall de Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning

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