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Bone Marrow Transplant

Chemotherapy w/wo TBI for MDS or AML (FHCRC-1992)
A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplantation in Patients with Myelodysplastic Syndrome or Acute Myelogenous Leukemia.
Status Conditions Phase Study ID
Closed Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase III FHCRC-1992
NCT00322101
Summary

The purpose of this research study is to compare treatment using low-dose chemotherapy and total-body irradiation with treatment using high-dose chemotherapy, in patients who are undergoing donor stem-cell transplant for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

A computer will randomly assign participants to either a high-dose (the conventional treatment) or lower-dose (non-myeloablative) treatment plan on this study.

Most of the care will be given at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. If hospitalization is needed while in Seattle, participants will be admitted to the UW Medical Center or Children’s Hospital and Regional Medical Center.

Treatment will last approximately 3 ½ months, but could last longer.

Participants may be asked to return for follow-up 6 months after the transplant, and every year thereafter. Blood and bone marrow samples may be requested after the participant returns home, for up to 5 years. These samples will be requested at the same time as the participant’s regularly scheduled doctor visits.


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

1. Patient has a diagnosis of one of the following:

· Myelodysplastic Syndrome (MDS).

· Acute Myelogenous Leukemia that has transformed from MDS (tAML).

· De novo Acute Myelogenous Leukemia (AML) beyond first remission.

· Intermediate or high-risk de novo AML in first complete response (only if the transplant donor is not related to the patient).

 

 

2. Patient is either:

· 65 years of age or younger (if the transplant donor is related to the patient).

· 60 years of age or younger (if the transplant donor is not related to the patient).

 

 

3. Patient must have had prior chemotherapy.

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

1. Pregnant or breastfeeding.

 

2. Male or female of childbearing potential, unwilling to use approved contraceptive methods during and for 12 months following treatment.

 

3. Fungal infection that can be detected by x-rays after taking an anti-fungal drug for more than a month.

 

4. Severe liver, heart, and/or lung disorder.

 

5. HIV-positive.

 

6. Use of therapy with some cytotoxic drugs within three weeks of starting study treatment.

 

7. Non-hematological tumor.

 

8. Active central nervous system (CNS) disease.

 

Other exclusion criteria may apply.

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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.