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Bone Marrow Transplant

I 131 Monoclonal Antibody BC8, Chemotherapy, TBI, and a Donor Bone Marrow Transplant for Advanced Acute Leukemia MDS (FHCRC-2186)
Hematopoietic Bone Marrow Transplantation for Patients with High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) using Related HLA-Mismatched Donors: A Trial Using Radiolabeled Anti-CD45 Antibody Combined with Immunosuppression Before and After Transplantation
Status Conditions Phase Study ID
Closed Leukemia
Myelodysplastic Syndromes
Phase I FHCRC-2186
NCT00589316
Summary
The purpose of this study is to learn more about an experimental, two-part treatment for patients with advanced acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or high-risk myelodysplastic syndrome (MDS). This study will look at the effects, good or bad, that this combined treatment has on the body and leukemia or MDS. The study will also help us determine the highest dose of radiation we can give safely. The two parts of the treatment are:

• targeted radiolabeled antibody therapy, followed by

• bone marrow transplant from a related, mismatched donor

The type of bone marrow transplant in this study has been used before to treat leukemia, MDS and other similar diseases. It has been effective in getting the donor’s stem cells to “take hold” in the recipient, but many patients relapse (the disease returns) after transplant. We want to find out if using the radiolabeled antibody before the transplant will reduce the number of patients who relapse after transplant.

Participants will receive treatment as outpatients at the Seattle Cancer Care Alliance (SCCA) and as inpatients at the University of Washington Medical Center (UWMC). The radiation used in the study requires participants to stay in a “radiation isolation” room at UWMC for about 5 to 10 days.

Participants in this study will need to be in Seattle for about 4 months. This includes about 3 weeks from the start of study participation until the bone marrow transplant, and then about 3 months of follow-up after the transplant.


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

1. Males or females with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS)

 • AML or ALL patients must have disease that has either:
- come back after first remission, or
- did not respond to initial treatment, or
- evolved from myelodysplastic or myeloproliferative syndrome

 • MDS patients must have one of the following:
- refractory anemia with excess blasts (RAEB),
- RAEB in transformation (RAEBT),
- refractory cytopenia with multilineage dysplasia (RCMD),
- RCMD with ringed sideroblasts (RCMD-RS), or
- chronic myelomonocytic leukemia (CMML)

2. Must be 18 years of age or older

3. Must have normal liver and kidney function

4. Must be physically able to meet study requirements

5. Must not have active infection

6. Must have a related donor who meets study guidelines

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

1. Already received maximum radiation to any organ

2. Severe heart problems requiring medication, or symptoms of coronary artery disease

3. Severe lung or liver problems

4. HIV positive

5. Medical or other condition that may prevent the patient from finishing the study

6. Pregnant or breast feeding

Other exclusion criteria may apply.

Last Updated
May 17, 2011
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.