Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies

Phase 2CompletedNCT01966510

Assistance Publique - Hôpitaux de Paris19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall survival

Time frame: 1 year

Secondary Outcomes

Engraftment

Neutrophils \> 500/mm3 and platelets \> 20 Giga/L

Time frame: 100 days

Chimerism

using PCR

Time frame: D15, D30, D60, D100, M6, M12 and M24

Acute Graft versus host disease (GvHD)

Time frame: 100 days

Chronic graft versus host disease (GVHD)

Time frame: within 2 years after inclusion

Immunologic reconstitution

phenotypic measurements of lymphocyrtes populations (T, B and NK)

Time frame: D30, D60, D100, M6, M12 and M24

Incidence of severe infectious complications

defined using criteria from EBMT (Cordonnier, www.ebmt.org)

Time frame: D100 and M12

Relapse rate

Time frame: within the 2 years after inclusion

Relapse free survival

Time frame: 2 years

toxicity

recorded according to OMS grading scale