IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
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|ClinicalTrials.gov Identifier: NCT01885897|
Recruitment Status : Completed
First Posted : June 25, 2013
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
This is a multi-center, phase I/II clinical trial for patients who have relapsed more than 60 day after allogeneic transplant for a hematologic malignancy. The study consists of two phases. The dose finding phase is a modified version of a phase I trial and the extended phase is a modified version of a phase II trial.
The primary objective of the dose finding phase is to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will follow a standard 3+3 design of dose escalation for toxicity with an added feature of stopping early if efficacy is confirmed. There are six dose levels of ALT-803 for to determine the MTD/MED: 1, 3, 6, 10, 20, and 30 mcg/kg.
Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase. The primary goal of this extended phase is to study the potential efficacy of ALT-803 in this patient population. Efficacy will be measured using rates of remission induction. An optimal Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or more of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia (AML) Acute Lymphoblastic Leukemia (ALL) Myelodysplastic Syndromes (MDS) Lymphoma Myeloma Chronic Lymphocytic Leukemia (CLL) Chronic Myelogenous Leukemia (CML)||Biological: ALT-803||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||November 11, 2013|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2020|
Experimental: Study treatment
Weekly dose of ALT-803 at assigned dose, ranging from 1mcg/kg to 30 mcg/kg (based on phase 1 dose escalation schedule,) IV once a week for 4 weeks.
Given weekly IV at assigned dose level, ranging from 1mcg/kg to 30mcg/kg.
- Number of Participants With Dose Limiting Toxicity (DLT) Events [ Time Frame: 4 weeks ]
The Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only):
- any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 188.8.131.52 for full definition)
- any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration
- grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle
- Number of Participants Experiencing Potential Efficacy of ALT 803 [ Time Frame: 4 months ]
The potential efficacy of ALT-803 in this patient population is measured by the responses based on bone marrow examination 1 and 3 months after the last dose of ALT-803.
Response was defined as follows: for AML and myelodysplastic syndromes (MDS) using the International Working Group modified criteria, non-Hodgkin lymphoma, and multiple myeloma using the International Myeloma Working Group Uniform Response Criteria, and acute lymphoblastic leukemia using protocol-specified criteria.
- Number of Participants With Excessive Toxicity [ Time Frame: 4 weeks ]To evaluate the safety of the ALT-803 when administered on this schedule. Excessive toxicity is defined as having a grade 3-5 non-hematologic, non-relapse and non-infectious toxicity (except fevers alone) based on the NCI's CTCAE version 4.
- Number of Participants With Incidence of Acute Graft Versus Host Disease [ Time Frame: 100 days ]
- Number of Participants With Incidence of Chronic Graft Versus Host Disease [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885897
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jeffrey S. Miller, MD||Masonic Cancer Center, University of Minnesota|