HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma

NCT ID: NCT02370160

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-21
• Study Completion Date: 2018-04-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DT2219ARL

A recombinant bispecific antibody-targeted toxin.

Group Type: EXPERIMENTAL

DT2219ARL

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronika Bachanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014LS093

Identifier Type: -

Identifier Source: org_study_id