Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
Conditions
Keywords
cord blood transplant, advanced lymphoid malignancies
Brief summary
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor. Objectives: Overall survival at one year. Efficacy \>60%, rejection rate \<20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (\<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation. Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.
Interventions
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years old * no sibling or unrelated donor identified (9/10 or 10/10) * with either one of these advanced lymphoid malignancies 1. low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation) 2. hodgkin lymphoma in early relapse (\<1 year)who received at least one autologous transplantation and sensible to chemotherapy 3. CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Exclusion criteria
* No patient signed consent * Previous allograft * Psychiatric conditions * HIV positive * HVC hepatitis requiring treatment * Previous total body irradiation (TBI) * Any contraindication to TBI * Any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions * No Health care insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chimerism | D15, D30, D60, D100, M6, M12 and M24 | using PCR |
| Acute Graft versus host disease (GvHD) | 100 days | — |
| Chronic graft versus host disease (GVHD) | within 2 years after inclusion | — |
| Immunologic reconstitution | D30, D60, D100, M6, M12 and M24 | phenotypic measurements of lymphocyrtes populations (T, B and NK) |
| Engraftment | 100 days | Neutrophils \> 500/mm3 and platelets \> 20 Giga/L |
| Relapse rate | within the 2 years after inclusion | — |
| Relapse free survival | 2 years | — |
| toxicity | 2 years | recorded according to OMS grading scale |
| Incidence of severe infectious complications | D100 and M12 | defined using criteria from EBMT (Cordonnier, www.ebmt.org) |
Countries
France
Outcome results
None listed