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Bone Marrow Transplant

Natural Killer Cell Therapy Post Non-Myeloablative BMT (FHCRC-2230)
A Phase I/II Study Evaluating the Safety and Efficacy of Adding a Single Prophylactic Donor Lymphocyte Infusion (DLI) of Natural Killer Cells Early After Nonmyeloablative, HLA-Haploidentical Hematopoietic Cell Transplantation
Status Conditions Phase Study ID
Recruiting Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Phase I/II FHCRC-2230
NCT00789776
Summary

The purpose of this research study is to determine whether or not the experimental addition of cells after a non-myeloablative bone-marrow transplant is safe for patients with life-threatening hematologic malignancies (diseases such as leukemia, lymphoma and others). This study also aims to determine the effects, good or bad, of this experimental treatment on recovery from transplant.

A non-myeloablative bone-marrow transplant uses milder or lower doses of chemotherapy and radiation than a standard transplant. Participants in this study will also receive additional cells from the donor a week after the transplantation. These additional cells are a type of white blood cell called natural killer cells (or NK cells).

This is an investigational study for patients who are not eligible for standard transplant treatment because they do not have a matched bone-marrow donor. The transplant treatment in this study uses an HLA-haploidentical donor (someone who is related to the patient and whose tissue type has some genetic similarity).

Study treatment will last about 3½ months, but could be longer. 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). Study participants may be asked to return for follow-up visits 6 months after the study treatment is complete and every year thereafter.

We would like to keep track of each participant’s medical condition for the rest of his or her life, to understand the long-term effects of the transplant.


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

1. Diagnosed with a life-threatening hematologic malignancy (according to study guidelines)

2. Not eligible for a conventional transplant

3. Related (family member) donor is available and has a tissue type that is partially matched

(HLA-haploidentical donor)

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• HLA-matched related or unrelated donor is available

• Patient is eligible for a curative autologous transplant

• Significant organ dysfunction that would prevent compliance with the protocol or would severely limit the probability of survival; severe liver, heart, and/or lung disorder

• HIV-positive or other active infectious disease concerns

• High blood pressure that cannot be controlled with medication

• Central nervous system involvement that does not respond to chemotherapy

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.