Acute Myeloid Leukemia
Conditions
Keywords
AML
Brief summary
The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
Interventions
BIOLOGICALGamma Delta T-Cell Infusion
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Florida Department of Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML * Have \< 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed * Karnofsky performance status (KPS) ≥ 70% during the study screening. * Free of symptomatic congestive heart failure or uncontrolled arrhythmia * Adequate organ function as defined per protocol * Negative serum pregnancy test * Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study. * Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion criteria
* Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function. * Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product). * Uncontrolled serious infection. * Morphologic relapse of leukemia at any timepoint after HCT. * Active central nervous system malignancy. * Pregnancy or lactation. * Treatment with another investigational drug or other intervention within 14 days of T-cell infusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | Up to 12 months | Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells. |
| Dose Expansion: Leukemia Free Survival | Up to 12 months | Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Graft Versus Host Disease (GVHD) | at 6 weeks | Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells |
| Overall Survival (OS) | Up to 12 months | The length of time from start of treatment to death by any cause. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNelli Bejanyan, MD
Moffitt Cancer Center
Outcome results
None listed