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

NCT02370160 | Completed Phase 1 Results DMC

• 1 other identifier: 2014LS093
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle

  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-hematologic adverse event occurring after completion of DT2219 infusion

  Day 1 - Day 29

• Phase ll: Overall Disease Response

  Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.

  Day 29

Secondary Outcomes (5)

• Incidence of Serious Adverse Events

  Day 29

• Phase II : Duration of Response

  1 year

• Disease-free Survival

  1 year

• Overall Survival

  1 year

• Time to Relapse/Progression

  1 year

Study Arms (1)

DT2219ARL

EXPERIMENTAL

A recombinant bispecific antibody-targeted toxin.

Biological: DT2219ARL

Interventions

DT2219ARL 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.

DT2219ARL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Results Point of Contact

• Title: Dr. Veronika Bachanova
• Organization: Masonic Cancer Center at University of Minnesota

pham0179@umn.edu

612-625-8287

Study Officials

• Veronika Bachanova, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 24, 2015
• Study Start: December 21, 2015
• Primary Completion: April 8, 2018
• Study Completion: April 8, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Locations

US (1)