QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).

Key facts

Study ID: NCT03050216
Run by: Masonic Cancer Center, University of Minnesota
People needed: 8
Starts: 2017-05-16
Expected to finish: 2019-12-15
Last updated by the study team: 2023-07-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Diagnosis of acute myeloid leukemia (AML) and meets one of the following disease criteria:
Primary induction failure:
De novo AML - no CR after 2 or more chemotherapy induction attempts
Secondary AML (from MDS or treatment related): no CR after 1 or more chemotherapy induction attempts
Relapse after chemotherapy: not in CR after 1, 2, or 3 re-induction attempts
Patients > 60 years of age, the 1 cycle of chemotherapy is not required
Relapse after hematopoietic stem cell transplant:
Relapse must have occurred > 18 months after transplant
No re-induction required and no more than 1 re-induction attempt is allowed
Notes:
For hypomethylating agents (i.e. decitabine, azacitidine) to count as an induction/re-induction attempt, the patient must have completed a minimum of 3 monthly cycles
For targeting agents (i.e. sorafenib) to count as an induction/re-induction attempt, the patient must have completed a minimum of 1 month without attaining CR
7+3 followed by 5+2 counts as TWO induction attempts
Use of hydroxyurea is permitted to control blasts until Day -3 per Section 8.7
A history of AML related CNS involvement is allowed if CSF analysis is negative on 2 test dates at least 2 weeks apart prior to study treatment. The use of ongoing CNS maintenance therapy is allowed while on study.
HLA-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele)
Karnofsky Performance Status ≥ 60%
Adequate organ function within 14 days of study registration (28 days for pulmonary and cardiac) defined as:
Creatinine: ≤ 2.0 mg/dL
Hepatic: AST and ALT < 3 x upper limit of institutional normal
Pulmonary Function: oxygen saturation ≥ 90% on room air; PFT's required only if symptomatic or prior known impairment - must have pulmonary function >50% corrected DLCO and FEV1.
Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA or cardiac MRI, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Able to be off prednisone or other systemic immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications) .
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy .
Voluntary written consent prior to the performance of any research related procedures.

You may not qualify if…

Acute leukemias of ambiguous lineage
Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening
Active autoimmune disease requiring systemic immunosuppressive therapy
History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
New or progressive pulmonary infiltrates on screening chest X-ray or chest CT scan unless cleared for study 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-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
Prior ALT-803

Where it is running

Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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