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


Phase 2
4 Years
65 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Transplant related mortality

Outcome Time Frame:

At 2 years

Safety Issue:

Yes

Principal Investigator

Bernard RIO, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P 060206

NCT ID:

NCT00797758

Start Date:

October 2007

Completion Date:

December 2011

Related Keywords:

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

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