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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226512

Enrollment

203

Registered

2005-09-27

Start date

2004-07-31

Completion date

Unknown

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome

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.

Interventions

DRUGCampath-1H /ATG

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Investigate the role of different conditioning regimens on:	—
Infection, engraftment relapse rate and disease free survival.	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026