Status:
COMPLETED
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells (PBSC)
Lead Sponsor:
University of Liege
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief Summary
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alo...
Eligibility Criteria
Inclusion
- Patients
- 1. Diseases
- Malignant diseases confirmed histologically and not rapidly progressing:
- Hematologic malignancies
- AML;
- ALL;
- CML and other myeloproliferative disorders;
- MDS;
- Multiple myeloma;
- CLL;
- Non-Hodgkin's lymphoma;
- Hodgkin's disease.
- Non-hematologic malignancies
- Renal cell carcinoma (metastatic).
- 2. Inclusion criteria
- Male or female; female patients must use a reliable contraception method;
- Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
- HIV negative;
- No terminal organ failure;
- No uncontrolled infection, arrhythmia or hypertension;
- Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
- No previous radiation therapy precluding the use of 2 Gy TBI
- Informed consent given by patient or his/her guardian if of minor age.
- 3. Clinical situations
- Theoretical disease indication for a standard allo-transplant, but not feasible because:
- Age \> 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
- Indication for a standard auto-transplant:
- perform mini-allotransplantation 2-6 months after standard autotransplant.
- Not an indication for intensification but a potential candidate for cellular immunotherapy.
- Donors
- 1. Inclusion criteria
- Related to the recipient (sibling, parent or child) or unrelated;
- Male or female;
- Weight \> 15 Kg (because of leukapheresis);
- HIV negative;
- No major contraindication for allogeneic PBSC donation by generally accepted criteria;
- Informed consent given by donor or his/her guardian if of minor age.
- 2. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- Unable to undergo leukapheresis because of poor vein access or other reasons.
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00693927
Start Date
March 1 2002
End Date
May 1 2008
Last Update
September 2 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Sart Tilman
Liège, Liege, Belgium, B4000