Clinical trial NCT01966510: Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies
Official title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
Keywords: cord blood transplant
advanced lymphoid malignancies
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Engraftment
timeFrame: 100 days
measure: Chimerism
timeFrame: D15, D30, D60, D100, M6, M12 and M24
measure: Acute Graft versus host disease (GvHD)
timeFrame: 100 days
measure: Chronic graft versus host disease (GVHD)
timeFrame: within 2 years after inclusion
measure: Immunologic reconstitution
timeFrame: D30, D60, D100, M6, M12 and M24
measure: Incidence of severe infectious complications
timeFrame: D100 and M12
measure: Relapse rate
timeFrame: within the 2 years after inclusion
measure: Relapse free survival
timeFrame: 2 years
measure: toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis hospital
Study officials:
References: