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A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Allograft, Allogeneic Cell Transplantaion, Hematological Malignancy, Solid Tumor

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Trial Information

A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation


Inclusion Criteria:



- hematological malignancy or solid tumor,

- eligible for non myeloablative allogenic transplantation,

- aged between 18 and 65,

- with a suitable HLA identical sibling

Exclusion Criteria:

- contra-indication to allogenic transplantation

- pregnant women or breast feeding

- active infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

one year overall survival (OS)

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Didier BLAISE, PUPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ITAC02-01

NCT ID:

NCT00894049

Start Date:

November 2002

Completion Date:

March 2013

Related Keywords:

  • Allograft
  • Allogeneic Cell Transplantaion
  • Hematological Malignancy
  • Solid Tumor
  • Neoplasms
  • Hematologic Neoplasms

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