Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies (LYMPHCORD)
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|ClinicalTrials.gov Identifier: NCT01966510|
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : December 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor||Other: Cord Blood Transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||December 2017|
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
- Overall survival [ Time Frame: 1 year ]
- Engraftment [ Time Frame: 100 days ]Neutrophils > 500/mm3 and platelets > 20 Giga/L
- Chimerism [ Time Frame: D15, D30, D60, D100, M6, M12 and M24 ]using PCR
- Acute Graft versus host disease (GvHD) [ Time Frame: 100 days ]
- Chronic graft versus host disease (GVHD) [ Time Frame: within 2 years after inclusion ]
- Immunologic reconstitution [ Time Frame: D30, D60, D100, M6, M12 and M24 ]phenotypic measurements of lymphocyrtes populations (T, B and NK)
- Incidence of severe infectious complications [ Time Frame: D100 and M12 ]defined using criteria from EBMT (Cordonnier, www.ebmt.org)
- Relapse rate [ Time Frame: within the 2 years after inclusion ]
- Relapse free survival [ Time Frame: 2 years ]
- toxicity [ Time Frame: 2 years ]recorded according to OMS grading scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966510
|Saint Louis hospital|
|Paris, France, 75010|