Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00797758

Purpose

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
Acute Myeloid Leukemia	Other: Cord blood transplantation	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Transplant related mortality [ Time Frame: At 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical efficiency (overall survival, event free survival, relapse incidence, acute and chronic GVHD incidence, graft failure, venoocclusive disease, interstitial pneumonia, infections, comorbidity score, quality of life and medico-economic impact) [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

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
1: Experimental Umbilical cord blood transplantation after reduced intensity conditioning	Other: Cord blood transplantation Umbilical cord blood transplantation after reduced intensity conditioning

Detailed Description:

Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.

Eligibility

Ages Eligible for Study:	4 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages : 4 to 65
De novo or secondary AML requiring allogeneic transplant
No donor (related or unrelated) compatible 10/10
Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17)
Smouldering AML without progression
Signed assent of recipient

Exclusion Criteria:

If CR1: AML with with t(8;21) or inv (16) or t (15;17)
Karnofsky < 50% - Clearance of creatinin < 40 ml/min
Transaminases > 8 N
Previous autologous or allogeneic transplantation within 6 month prior to the study (except if tandem)
total body irradiation contra-indicating 2 Gy TBI
local irradiation contra-indicating 2 Gy TBI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797758

Contacts

Contact: Bernard Rio, MD, PhD

33 (0) 1 42 34 84 19

bernard.rio@htd.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Bernard RIO, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

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
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Quality of Life

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009