Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies

NCT01966510 | Completed Phase 2 DMC

• 1 other identifier: P110145
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cord blood transplant; advanced lymphoid malignancies

Outcome Measures

Primary Outcomes (1)

• Overall survival

  1 year

Secondary Outcomes (9)

• Engraftment

  100 days

• Chimerism

  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

  D30, D60, D100, M6, M12 and M24

Study Arms (1)

Cord blood transplantation

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.

Other: Cord Blood Transplantation

Interventions

Cord Blood Transplantation OTHER

Cord blood transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis hospital

Paris, 75010, France

Location

MeSH Terms

Interventions

Cord Blood Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

FR (1)