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Phase III Trial of a Non-myeloablative Preparative Regimen With Fludarabine and Busulfan With or Without Anti-lymphocyte Antibodies (Campath-1H or ATG) for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Stem Cell Transplantation From an HLA Compatible Donor


Phase 3
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase III Trial of a Non-myeloablative Preparative Regimen With Fludarabine and Busulfan With or Without Anti-lymphocyte Antibodies (Campath-1H or ATG) for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Stem Cell Transplantation From an HLA Compatible Donor


Inclusion Criteria:



- Confirmed diagnosis of AML or MDS, with no lower or upper age limit:

- a) Induction failure

- b) First or subsequent remission

- c) Untreated first relapse

- Patients must have an HLA compatible donor willing and capable of donating peripheral
blood stem cells (first choice) or bone marrow progenitor cells using conventional
techniques and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6
matched related or 10/10 molecular matched unrelated donor (A,B,C,DR,DRB1).

Exclusion Criteria:

- Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B
antigenemia).

- Evidence of bone marrow disease.

- Unable to donate bone marrow or peripheral blood due to concurrent medical condition.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of s.c. Campath-1H or ATG in decreasing the incidence and severity of acute and chronic GVHD in patients with AML and MDS treated with non-myeloablative stem cell transplantation.

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

230704-HMO-CTIL

NCT ID:

NCT00226512

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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