CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission

Withdrawn before enrolling · Phase 2

Conditions studied: Acute Myelogenous Leukemia

In brief

This is a phase II trial designed to test the safety and efficacy (disease free survival \[DFS\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60 years and older who are in a first complete remission after 1 or 2 courses of standard AML induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.

Key facts

Study ID

NCT01639456

Run by

Masonic Cancer Center, University of Minnesota

People needed

0

Starts

2013-10-01

Expected to finish

2017-01-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute myelogenous leukemia (except acute promyelocytic leukemia) in a first complete remission (CR1) and meet the following criteria:
• Meets the definition of complete remission by morphologic criteria including <5% blasts in a moderately cellular (> 20% cellularity) or cellular marrow.
• Complete remission (CR) was achieved after no more than 2 cycles of standard induction chemotherapy. Early re-induction therapy based on residual disease on a day 14 bone marrow (BM) will count as a 2nd cycle. Prior therapy with demethylating agents (i.e. azacitidine) is allowed, but patients must have attained CR after standard cytotoxic therapy (defined as absolute neutrophil count (ANC) > 1000 cells/μL, platelets > 100 x 10\^9/L)
• No more than 3 months have lapsed from attainment of CR1
• No acute myelogenous leukemia (AML) consolidation therapy administered prior to enrollment
• Not a candidate for allogeneic stem cell transplantation
• ≥ 60 years of age
• Karnofsky performance status ≥ 70%
• Available related HLA haploidentical natural killer (NK) cell donor (sibling, offspring, or offspring of an HLA identical sibling) by at least Class I serologic typing at the A\&B locus (donor age 18-75 years)
• At least 30 days since last dose of chemotherapy
• Adequate organ function within 14 days of enrollment defined as:
• Creatinine: ≤ 2.0 mg/dL
• Hepatic: aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) < 5 x upper limit of institutional normal (ULN)
• Pulmonary: oxygen saturation ≥ 90% on room air
• Cardiac: left ventricular ejection fraction (LVEF) by echocardiogram (ECHO or MUGA) ≥ 40%, no uncontrolled angina, uncontrolled atrial or ventricular arrhythmias, or evidence of acute ischemia or active conduction system abnormalities (rate controlled a-fib is not an exclusion)
• Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to the NK cell infusion (excluding preparative regimen pre-meds)
• Voluntary written consent

You may not qualify if…

• Biphenotypic acute leukemia
• New progressive pulmonary infiltrates on screening chest x-ray or chest Computed Tomography scan that has not been evaluated with bronchoscopy (when feasible). Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
• Uncontrolled bacterial, fungal, or viral infections including human immunodeficiency virus (HIV) - chronic asymptomatic viral hepatitis is allowed
• Pleural effusion large enough to be detectable on chest x-ray
• Known hypersensitivity to one or more of the study agents
• Donor Selection:
• Related donor (sibling, offspring, or offspring of an HLA identical sibling) 18-75 years of age
• At least 40 kilograms
• In general good health as determined by the medical provider
• Negative for hepatitis and HIV on donor viral screen
• HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus
• Not pregnant
• Voluntary written consent

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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