Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies

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

— LYMPHCORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966510
• Other study ID #: P110145
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2013
• Last updated: December 7, 2017
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Cord Blood Transplantation

Locations

Country	Name	City	State
France	Saint Louis hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year
Secondary	Engraftment	Neutrophils > 500/mm3 and platelets > 20 Giga/L	100 days
Secondary	Chimerism	using PCR	D15, D30, D60, D100, M6, M12 and M24
Secondary	Acute Graft versus host disease (GvHD)		100 days
Secondary	Chronic graft versus host disease (GVHD)		within 2 years after inclusion
Secondary	Immunologic reconstitution	phenotypic measurements of lymphocyrtes populations (T, B and NK)	D30, D60, D100, M6, M12 and M24
Secondary	Incidence of severe infectious complications	defined using criteria from EBMT (Cordonnier, www.ebmt.org)	D100 and M12
Secondary	Relapse rate		within the 2 years after inclusion
Secondary	Relapse free survival		2 years
Secondary	toxicity	recorded according to OMS grading scale	2 years