Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— MINICORD  

Official title:

Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797758
• Other study ID #: P 060206
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2008
• Last updated: March 7, 2013
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Cord blood transplantation
Umbilical cord blood transplantation after reduced intensity conditioning

Locations

Country	Name	City	State
France	Département d'Hématologie et d'Oncologie Médicale, Hôtel-Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant related mortality		At 2 years	Yes
Secondary	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)		at 2 years	No