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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00797758 |
Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Other: Cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia. |
Estimated Enrollment: | 76 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Umbilical cord blood transplantation after reduced intensity conditioning
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Other: Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning
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Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
Ages Eligible for Study: | 4 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bernard Rio, MD, PhD | 33 (0) 1 42 34 84 19 | bernard.rio@htd.aphp.fr |
France | |
Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu | Recruiting |
Paris, France, 75001 | |
Contact: Bernard Rio, MD, PhD | |
Principal Investigator: Bernard Rio, MD, PhD |
Principal Investigator: | Bernard RIO, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Therese Ngoue ) |
Study ID Numbers: | P 060206, AOM 06206 |
Study First Received: | November 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797758 History of Changes |
Health Authority: | France: Ministry of Health |
Cord blood transplantation Conditioning regimen Acute myeloid leukaemia SORROR comorbidity index Quality of life |
Innate immunity Immune reconstitution post transplant Umbilical Cord Blood Stem Cell Transplantation Hematopoietic Stem Cell Transplantation |
Leukemia Acute Myelocytic Leukemia Quality of Life Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |