Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions

Completed · Phase 1

Conditions studied: Lymphoma, Myeloma, Leukemia

In brief

The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.

Key facts

Study ID

NCT00660166

Run by

Tufts Medical Center

People needed

13

Starts

2006-04-01

Expected to finish

2012-06-01

Last updated by the study team

2012-06-27

Who can join

Age: 13 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have undergone an autologous stem cell transplant for the following diseases:
• Acute Myeloid Leukemia
• Non-Hodgkin's Lymphoma
• Hodgkin's Disease
• Multiple Myeloma
• Age 13 - 70 years old
• Able to give informed consent
• Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
• ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
• Patients with no active infection

You may not qualify if…

• Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have > grade 2 toxicity in any organ system)
• Patients who have insufficient engraftment parameters according to the following criteria: WBC < 2,500 /mm3 and platelets < 50,000/mm3
• Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
• Intrinsic impaired organ function (as stated above).
• Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
• Uncontrolled, life-threatening infections at the time of infusion.
• Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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