Trials / Completed
CompletedNCT01885897
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic Stem Cell Transplantation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Acute Myelogenous Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Myelodysplastic Syndromes (MDS)
- Lymphoma
- Myeloma
- Chronic Lymphocytic Leukemia (CLL)
- Chronic Myelogenous Leukemia (CML)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALT-803 | Given weekly IV at assigned dose level, ranging from 1mcg/kg to 30mcg/kg. |
Timeline
- Start date
- 2013-11-11
- Primary completion
- 2019-07-01
- Completion
- 2020-07-01
- First posted
- 2013-06-25
- Last updated
- 2020-08-12
- Results posted
- 2020-08-12
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01885897. Inclusion in this directory is not an endorsement.