To Determine the Role of Adding Campath-1H or ATG Given In-vivo in Addition to Fludarabine and Low Dose Busulfex on Outcome in Patients Treated With Reduced Intensity Conditioning

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00226512
• Other study ID #: 230704-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 7, 2011
• Start date: July 2004

Study information

• Verified date: September 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized Campath-1H administered s.c. or polyclonal rabbit anti-T lymphocyte antibodies (ATG), combined with low dose and short course cyclosporine A (CSA) and methotrexate (MTX) as the sole agent for prevention of graft-vs-host disease (GVHD) for patients with acute myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell transplantation from an HLA compatible donor.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 203
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Campath-1H /ATG

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Bayer

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Investigate the role of different conditioning regimens on:
Secondary	Infection, engraftment relapse rate and disease free survival.