Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.

Conditions
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Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor

Intervention / Treatment
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* Other: Cord Blood Transplantation


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cord blood transplantation<br>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. | Other: Cord Blood Transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cord blood transplant, advanced lymphoid malignancies