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Bone Marrow Transplant

Low-dose TBI Dose Escalation Before HCT for CMML, MDS or MPD (FHCRC-2056)
Low-dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection after Hematopoietic Cell Transplantation with Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders -- A Multi-Center Trial
Status Conditions Phase Study ID
Recruiting Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Secondary Myelofibrosis
Phase II FHCRC-2056
NCT00397813
Summary

This non-myeloablative, stem cell transplant study is for adults who have chronic myelomonocytic leukemia (CMML), or previously untreated myelodysplastic syndrome (MDS) or myeloproliferative disorders (MPD). The participants in this study have either an HLA-matched, related donor or an HLA-matched, unrelated donor available to donate the stem cells needed for the transplant.

Non-myeloablative stem cell transplants use lower doses of chemotherapy and total body irradiation (TBI) than conventional stem cell transplants. In previous studies, participants with MDS, CMML and MPD were shown to be at an increased risk of rejecting their donor's stem cells, and of having their disease relapse soon after transplantation. It is unknown what dose of TBI will be effective enough to prevent graft rejection and disease progression. The purpose of this study is to find a safe and effective dose of TBI (given before the transplant) to prevent graft rejection and/or disease relapse after the transplant. Participants in non-myeloablative transplants also receive drugs to suppress their immune systems. We will also evaluate whether or not these drugs, called cyclosporine and mycophenolate mofetil (MMF), can help prevent graft-versus-host disease (GVHD). GVHD is a serious side effect that can occur after a transplant. It is an inflammatory disease that occurs when the "new" cells (the donor's cells) react against the participant's cells.

We plan to treat the participant at the Seattle Cancer Care Alliance outpatient clinic. The study treatment and initial follow-up will last about three and a half months. If hospitalization is needed, the participant will be admitted to the University of Washington Medical Center.

Before the transplant, participants will receive the drugs fludarabine and cyclosporine. On the day of the transplant, the participant will receive low-dose, total body irradiation (TBI). The participant will also start taking a drug called mycophenalate mofetil (MMF). The participant will be monitored closely following the transplant. We will continue standard follow-up for five years. We would like to continue to keep track of the participant's medical condition for his or her lifetime to look at the long-term effects of the study.


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

1. Participant is:

 

a. Within the age range of 50 to 74 years OR

 

b. Less than 50 years of age, but at high risk for regimen-related toxicity using standard, high-dose regimens.

 

2. Participant has been diagnosed with CMML or has previously untreated MDS or MPD.

 

3. Participant has a matched, related donor or a matched, unrelated donor.

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

1. HIV-positive or other serious, active viral, bacterial or fungal infection.

 

2. Active central nervous system involvement with the disease.

 

3. Presence, or likely occurrence, of other non-hematologic, malignant disease according to study guidelines.

 

4. Pregnant or breastfeeding.

 

5. Severe heart, lung, kidney or liver disorder.

 

6. Medical or physical condition that may prevent the participant from completing the study.

 

Other exclusion criteria may apply.

Last Updated
May 26, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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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.