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
• Interventions: Other: Cord Blood Transplantation

• 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

Arm && Interventions

Group	Intervention	Description
Cord blood transplantation	Cord Blood Transplantation	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
Acute Graft versus host disease (GvHD)	100 days
Relapse free survival	2 years
toxicity	2 years	recorded according to OMS grading scale
Engraftment	100 days	Neutrophils \> 500/mm3 and platelets \> 20 Giga/L
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)
Chimerism	D15, D30, D60, D100, M6, M12 and M24	using PCR
Chronic graft versus host disease (GVHD)	within 2 years after inclusion

Trial Locations

Locations (1)

Saint Louis hospital; 🇫🇷 Paris, France