HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
Completed · Phase 1/Phase 2
Conditions studied: Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma, Relapsed B-Lineage Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02370160
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 18
- Starts
- 2015-12-21
- Expected to finish
- 2018-04-08
- Last updated by the study team
- 2020-01-13
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
- Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
- Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
- Recovered from effects of prior therapy
- Peripheral blast count under 50 x 10\^9/L
- Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
- Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
- Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
You may not qualify if…
- Presence of leukemic or infectious pulmonary parenchymal disease
- Presence of active CNS leukemia
- Presence of any uncontrolled systemic infection
- Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
- Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
- Active Hepatitis B or Hepatitis C (virus detectable by PCR)
- Documented penicillin or cephalosporin allergies
- Pregnant or lactating
Where it is running
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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