Trials / Completed
CompletedNCT02370160
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Refractory B-Lineage Leukemia
- Relapsed B-Lineage Leukemia
- Refractory B-Lineage Lymphoma
- Relapsed B-Lineage Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DT2219ARL | DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity. |
Timeline
- Start date
- 2015-12-21
- Primary completion
- 2018-04-08
- Completion
- 2018-04-08
- First posted
- 2015-02-24
- Last updated
- 2020-01-13
- Results posted
- 2020-01-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02370160. Inclusion in this directory is not an endorsement.