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Bone Marrow Transplant

Unrelated Donor Cord Blood Transplant w/Reduced-intensity Preparative Regimen (FHCRC-2239)
Transplantation of Unrelated Donor Umbilical Cord Blood in Patients with Hematological Malignancies Using a Reduced-intensity Preparative Regimen
Status Conditions Phase Study ID
Recruiting Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase II FHCRC-2239
NCT00723099
Summary

The purpose of this research study is to determine the safety and effectiveness of an experimental treatment for leukemias, lymphomas and other blood disorders. This study uses low-dose chemotherapy and radiation, followed by a stem cell transplant that uses umbilical cord blood as the stem cell source, in patients who cannot tolerate a standard transplant treatment. Standard transplant treatments use higher doses of drugs and radiation and different types of drugs.

Participants in this study will be hospitalized for the transplant. Adult participants will be hospitalized at the University of Washington Medical Center, and pediatric participants at Seattle Children's. Once discharged from the hospital, follow-up visits will continue at the Seattle Cancer Care Alliance (SCCA) outpatient clinic.

The study treatment, including visits to the SCCA clinic after the transplant, will last about 3 ½ months. Less frequent follow-up visits to the study participant's local physician may be requested for up to 2 years after transplant.

After 2 years, we would like to continue to keep track of the participant's medical condition (by phone) to look at the long-term effects of the study.


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

1. Less than 70 years of age

2. Diagnosed with any of the following diseases:

- Acute Myeloid Leukemia (AML)

- Acute Lymphoblastic Leukemia (ALL)

- Chronic Myelogenous Leukemia (CML)

- Myelodysplastic Syndrome (MDS)

- Myeloproliferative Disorders (MPD)

- Large-cell lymphoma and aggressive T-cell lymphoma

- Chronic Lymphocytic Leukemia (CLL)

- Small Lymphocytic Lymphoma (SLL)

- Hodgkin’s Disease

- Follicular lymphoma, marginal zone B-Cell lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, or indolent T-cell lymphomas

- Multiple Myeloma (MM)

- Active or recent invasive fungal infection without consult and approval of SCCA Infectious Disease department

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Patients with an available, matched stem-cell donor.

- Pregnancy or breastfeeding.

- Evidence of HIV infection or known HIV positive serology.

- Uncontrolled viral or bacterial infection at the time of study enrollment.

- Active central nervous system malignancy.

Other exclusion criteria may apply.

Last Updated
April 04, 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.