Status:
WITHDRAWN
QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
University of Minnesota
Conditions:
High-Risk Acute Myeloid Leukemia
Treatment-Related Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution usin...
Eligibility Criteria
Inclusion
- Age ≥18 to ≤70 years
- Meets one of the following disease and risk categories:
- High-Risk Acute Myeloid Leukemia (AML) with predicted risk of relapse higher than 30%, which includes, but not limited to the following:
- Patients in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers.
- Patients with the following karyotypes in morphological CR or CRi: ELN-Intermediate I, Adverse, ELN-Intermediate-II. (18) (Examples include monosomal karyotype, complex karyotype, mutant p53, mutant RUNX1, mutant ASXL1, mutant FLT3-ITD, mutant DNMT3A, Inversion 3, T(6:9), KIT mutated core binding factor AML)
- Treatment-Related AML and Secondary AML in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers
- Myelodysplastic Syndrome (MDS) with \< 5% blasts by morphology and meets at least one of the following:
- Received intensive induction chemotherapy (i.e. 7+3 or MEC) OR
- Progression after 4 cycles of hypomethylating agents
- The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
- Karnofsky performance status ≥ 60% (appendix IV)
- Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) defined as:
- Hepatic: AST and ALT \< 3 x upper limit of institutional normal
- Renal: estimated glomerular filtration rate (GFR) ≥ 40 mL/min/1.73m2
- Pulmonary: oxygen saturation ≥ 90% on room air with no symptomatic pulmonary disease. If symptomatic or prior known impairment DLCOcor ≥ 40%.
- Cardiac: 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 immunosuppressive medications for at least 3 days prior to transplant (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
Exclusion
- Acute leukemias of ambiguous lineage
- Allogeneic transplant for AML within the previous 6 months (no time limit for autologous transplant)
- Active CNS disease - if a history of AML related CNS involvement, screening CSF analysis must be negative
- 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
- Active concomitant second malignancy (i.e. has required treatment in the previous 6 months)
- Known hypersensitivity to any of the study agents
- Received any investigational drugs within the 14 days before 1st dose of fludarabine
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03365661
Start Date
October 30 2018
End Date
January 1 2023
Last Update
November 9 2018
Active Locations (1)
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1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455