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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

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

Treatments: Other: Cord Blood Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01966510

P110145

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Cord blood transplantation

Experimental group

Description:

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.

Treatment:

Other: Cord Blood Transplantation