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Bone Marrow Transplant

Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) (FHCRC-1981)
A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation from HLA-Class I or Class II Mismatched, Unrelated Donors
Status Conditions Phase Study ID
Closed Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase I/II FHCRC-1981
NCT00555048
Summary

The purpose of this study is to determine whether or not adding a drug called Alemtuzumab to a standard transplantation treatment is safe and effective for patients with life-threatening hematologic malignancies such as leukemia or lymphoma. The addition of Alemtuzumab to the standard transplantation treatment is experimental.

Participants in the study will receive a standard conditioning regimen (chemotherapy drugs that are given prior to the stem cell transplantation) with the addition of the study drug, Alemtuzumab. Participants will then receive a transplantation of peripheral blood stem cells from a donor who is not a family member (an HLA-mismatched unrelated donor).

Participants will receive treatment at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).

Treatment will last at least 3 ½ months after the day of the transplant. Participants will also be evaluated one year after the transplant.

We would like to keep track of each participant’s medical condition and health for the rest of his or her life to look at the long-term effects of the study.


Investigator
Ann Woolfrey, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

• Patients with life-threatening hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia, advanced myelodysplastic syndrome, advanced chronic myeloid leukemia.

 

• Age less than 51 years.

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• Patients with HLA-matched related or unrelated donors.

 

• Patients with poor heart, lung, kidney, or liver function.

 

• Patients with HIV.

 

Other exclusion criteria may apply.

Last Updated
June 02, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.