EUCTR2007-002548-12-NLActive, not recruitingPhase 1
Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLI
CHU-ULG0 sites107 target enrollmentStarted: December 10, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 107
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Hematological malignancies confirmed histologically and not rapidly progressing.
- •2. Ineligible for conventional allogeneic transplantation because of age or comorbidities.
- •3. 10/10 HLA-allele-matched related or unrelated donors.
- •4. Male or female; fertile patients must use a reliable contraception method;
- •5. Age < 75 yrs;
- •6. Informed consent given by patient or his/her guardian if of minor age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. HIV positive;
- •2. Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT.
- •3. Life expectancy severely limited by disease other than malignancy;
- •4. Administration of cytotoxic agent(s) for cytoreduction” within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
- •5. CNS involvement with disease refractory to intrathecal chemotherapy.
- •6. Terminal organ failure, except for renal failure (dialysis acceptable)
Investigators
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