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 : Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : September 26, 2018
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)|
|Estimated Enrollment :||61 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|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 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.
- Dose Finding Phase: Safe dose of ALT-803 [ Time Frame: 4 weeks ]To establish a safe dose of ALT-803 given weekly for 4 doses in patients with hematologic malignancy who have relapsed after allogeneic transplant
- Extended Phase: Efficacy of ALT-803 [ Time Frame: 4 months ]To study the potential efficacy of ALT-803 in this patient population as measured by the rates of remission induction
- Number of patients 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.
- Incidence of acute graft versus host disease [ Time Frame: 100 days ]
- 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|