Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies

Phase 2

Completed

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

• Registration Number: NCT01966510
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-21
• Primary Completion: 2015-03
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
Acute Graft versus host disease (GvHD)	100 days
toxicity	2 years	recorded according to OMS grading scale
Relapse free survival	2 years
Relapse rate	within the 2 years after inclusion
Immunologic reconstitution	D30, D60, D100, M6, M12 and M24	phenotypic measurements of lymphocyrtes populations (T, B and NK)
Incidence of severe infectious complications	D100 and M12	defined using criteria from EBMT (Cordonnier, www.ebmt.org)
Engraftment	100 days	Neutrophils \> 500/mm3 and platelets \> 20 Giga/L
Chronic graft versus host disease (GVHD)	within 2 years after inclusion
Chimerism	D15, D30, D60, D100, M6, M12 and M24	using PCR

Trial Locations

Locations (1)

Saint Louis hospital; 🇫🇷 Paris, France