Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies (LYMPHCORD)

A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.

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 Overview

• Status: Completed
• Conditions: Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
• Intervention / Treatment: Other: Cord Blood Transplantation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Saint Louis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Cord Blood Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engraftment	Neutrophils > 500/mm3 and platelets > 20 Giga/L	100 days
Chimerism	using PCR	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	phenotypic measurements of lymphocyrtes populations (T, B and NK)	D30, D60, D100, M6, M12 and M24
Incidence of severe infectious complications	defined using criteria from EBMT (Cordonnier, www.ebmt.org)	D100 and M12
Relapse rate		within the 2 years after inclusion
Relapse free survival		2 years
toxicity	recorded according to OMS grading scale	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: cord blood transplant; advanced lymphoid malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: P110145