CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR

Stopped early · Not applicable

Conditions studied: Acute Myelogenous Leukemia

In brief

This is a phase II trial designed to test the safety and efficacy (complete response \[CR\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one or two standard induction attempts receive after a preparative regimen of cyclophosphamide and fludarabine a single infusion of 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

NCT03152526

Run by

Miltenyi Biotec B.V. & Co. KG

People needed

1

Starts

2017-10-18

Expected to finish

2018-03-21

Last updated by the study team

2020-07-09

Who can join

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

You may qualify if…

• Newly diagnosed with acute myelogenous leukemia (except acute promyelocytic leukemia) and has failed one or two prior standard induction attempts. Failure is defined as:
• ≥ 30% bone marrow blasts with at least 20% cellularity at mid-cycle bone marrow biopsy or residual AML on subsequent\~ day 28 bone marrow biopsy by morphology, flow, PCR or FISH
• Patients enrolling after only 1 failed induction attempt must meet at least one of the following additional eligibility criteria of high risk: ≥ 60 years of age adverse cytogenetics or molecular characteristics
• AML that progressed out of myelodysplastic syndrome (MDS) is eligible if the patient did not receive treatment directed at the MDS
• HLA-haploidentical related donor (aged 12 to 70 years)
• ≥ 18, but < 75 years of age
• Karnofsky performance status ≥ 60%
• Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) as defined in section 4.5
• 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)
• No prior hematopoietic transplant
• Not pregnant or lactating
• Sexually active females of childbearing potential and males with partners of child bearing potential must agree to use birth control

You may not qualify if…

• Pregnant or lactating as the treatments used in this study includes drugs that are FDA Pregnancy Category D.
• Acute leukemias of ambiguous lineage
• AML that transformed from previously treated myelodysplastic syndromes
• Prior hematopoietic transplant
• New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been cleared by Pulmonary. 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 HIV - chronic asymptomatic viral hepatitis is allowed
• Known hypersensitivity to one or more of the study agents used

Where it is running

• Universtiy of Chicago — Chicago, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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