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

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, September 2005

Sponsors and Collaborators:	Hadassah Medical Organization Bayer
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00226512

Purpose

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	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome	Drug: Campath-1H /ATG	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Alemtuzumab Immunoglobulins Globulin, Immune Campath Busulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	203
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226512

Contacts

Contact: Shimon Slavin, MD	+972-2-6776561	slavin@hadassah.org.il
Contact: Michael Y Shapira, MD	+972-2-6778351	shapiram@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD +972-2-6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD +972-2-6777572 lhadas@hadassah.org.il
Principal Investigator: Shimon Slavin, MD

Sponsors and Collaborators

Hadassah Medical Organization

Bayer

Investigators

Principal Investigator:

Shimon Slavin, MD

Hadassah Medical Organization

More Information

Study ID Numbers:	230704-HMO-CTIL
Study First Received:	September 9, 2005
Last Updated:	December 12, 2005
ClinicalTrials.gov Identifier:	NCT00226512
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Leukemia, Myeloid
Fludarabine monophosphate
Leukemia, Myeloid, Acute

Leukemia
Antibodies
Preleukemia
Busulfan
Alemtuzumab
Fludarabine
Bone Marrow Diseases
Acute myelocytic leukemia
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009