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NCT02370160 · ClinicalTrials.gov registry record · Phase 1
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
A Phase 1 study of Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02370160: Completed Phase 1 study of Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia, sponsored by Masonic Cancer Center, University of Minnesota.
NCT02370160 is a Phase 1 study of Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02370160, a Phase 1 study of Refractory B-Lineage Leukemia and Relapsed B-Lineage Leukemia, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.
Primary Outcome
Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematolog
Conditions Studied
Interventions
- BIOLOGICAL DT2219ARL
Study Locations (1)
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2018-04-08 |
| Phase | Phase 1 |
What the finished NCT02370160 record still lists
NCT02370160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 4 conditions, with Refractory B-Lineage Leukemia appearing as the primary indexed condition, and to 1 intervention - of which DT2219ARL is the first listed.
NCT02370160 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02370160 about?
NCT02370160 is a clinical study titled "HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma". This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but ...
What is the current status of trial NCT02370160?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-12-21. Estimated completion is 2018-04-08.
What conditions does trial NCT02370160 study?
This clinical trial studies the following conditions: Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma, Relapsed B-Lineage Lymphoma.
What interventions are being tested in trial NCT02370160?
The interventions under investigation include: DT2219ARL (BIOLOGICAL).
Who is sponsoring clinical trial NCT02370160?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02370160 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02370160's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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
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