Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Leukemia, Solid Tumors

In brief

This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.

Key facts

Study ID

NCT00582816

Run by

University of Wisconsin, Madison

People needed

9

Starts

2008-08-01

Expected to finish

2015-08-01

Last updated by the study team

2019-12-09

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Solid tumors that have failed auto transplant or are ineligible to receive auto transplant
• Relapsed AML in 1st relapse or 2nd or 3rd CR
• Relapsed ALL if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy.
• Greater than or equal to 6 months and <26 years old
• Suitable haploidentical donor available

You may not qualify if…

• Leukemia with >25% blasts in bone marrow at the time of admission to the HSCT unit.
• Serum bilirubin >3 mg/dl
• GFR <40 ml/min/1.73 mw
• Cardiac left ventricular ejection fraction <40%
• HIV+
• Pregnant

Where it is running

• Kenneth DeSantes., MD — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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