Overview

This trial is active, not recruiting.

Condition patients with advanced lymphoid malignancies in the absence of an hla identical or mismatch donor
Treatment cord blood transplantation
Phase phase 2
Sponsor Assistance Publique - Hôpitaux de Paris
Start date March 2013
End date March 2015
Trial size 19 participants
Trial identifier NCT01966510, P110145

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
cord blood transplantation

Primary Outcomes

Measure
Overall survival
time frame: 1 year

Secondary Outcomes

Measure
Engraftment
time frame: 100 days
Chimerism
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
time frame: D30, D60, D100, M6, M12 and M24
Incidence of severe infectious complications
time frame: D100 and M12
Relapse rate
time frame: within the 2 years after inclusion
Relapse free survival
time frame: 2 years
toxicity
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.