Study Stopped
the PI is no longer work at Hadassah
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
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
1 other identifier
interventional
203
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 27, 2005
CompletedApril 8, 2011
September 1, 2005
September 9, 2005
April 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Investigate the role of different conditioning regimens on:
Infection, engraftment relapse rate and disease free survival.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Bayercollaborator
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shimon Slavin, MD
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 27, 2005
Study Start
July 1, 2004
Last Updated
April 8, 2011
Record last verified: 2005-09