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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cord blood transplantation | Experimental | Two cord blood units containing both together more than 3x10^7 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cord Blood Transplantation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment | Neutrophils > 500/mm3 and platelets > 20 Giga/L | 100 days |
| Chimerism | using PCR | D15, D30, D60, D100, M6, M12 and M24 |
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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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis hospital | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
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| Acute Graft versus host disease (GvHD) | 100 days |
| Chronic graft versus host disease (GVHD) | within 2 years after inclusion |
| Immunologic reconstitution | phenotypic measurements of lymphocyrtes populations (T, B and NK) | D30, D60, D100, M6, M12 and M24 |
| Incidence of severe infectious complications | defined using criteria from EBMT (Cordonnier, www.ebmt.org) | D100 and M12 |
| Relapse rate | within the 2 years after inclusion |
| Relapse free survival | 2 years |
| toxicity | recorded according to OMS grading scale | 2 years |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |