Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01885897 · ClinicalTrials.gov registry record · Phase 1
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01885897: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01885897 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885897, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
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 6.2.1.1 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
Interventions
- BIOLOGICAL ALT-803
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-11-11 |
| Est. Completion | 2020-07 |
| Phase | Phase 1 |
What the finished NCT01885897 record still lists
NCT01885897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which ALT-803 is the first listed.
NCT01885897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01885897 about?
NCT01885897 is a clinical study titled "IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT". 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 o...
What is the current status of trial NCT01885897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-11-11. Estimated completion is 2020-07.
What interventions are being tested in trial NCT01885897?
The interventions under investigation include: ALT-803 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01885897?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01885897's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02861898 · 33 participants · Phase 1
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
- NCT04871607 · 33 participants · Phase 2
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
- NCT05071937 · 33 participants · Phase 2
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
- NCT05168618 · 33 participants · Phase 2
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI