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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00226512
• Collaborator: Bayer (Industry)
• Enrollment: 203
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia; Myelodysplastic Syndrome	Drug: Campath-1H /ATG	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 203 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Investigate the role of different conditioning regimens on: []

2. Infection, engraftment relapse rate and disease free survival. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• 1. Induction failure
• 1. First or subsequent remission
• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization
• Bayer

Investigators

• Principal Investigator: Shimon Slavin, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00226512
• Other Study ID Numbers: 230704-HMO-CTIL
• First Posted: Sep 27, 2005
• Last Update Posted: Apr 8, 2011
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Syndrome; Alemtuzumab

Study Results

No Results Posted as of Apr 8, 2011