Clinical Trials /

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

NCT02370160

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • B-Cell Prolymphocytic Leukemia
  • Hairy Cell Leukemia
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
  • Official Title: HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 2014LS093
  • NCT ID: NCT02370160

Conditions

  • Refractory B-Lineage Leukemia
  • Relapsed B-Lineage Leukemia
  • Refractory B-Lineage Lymphoma
  • Relapsed B-Lineage Lymphoma

Interventions

DrugSynonymsArms
DT2219ARLDT2219ARL

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
DT2219ARLExperimentalA recombinant bispecific antibody-targeted toxin.
  • DT2219ARL

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
Time Frame:Day 1 - Day 29
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Incidence of Serious Adverse Events
Time Frame:Day 29
Safety Issue:
Description:A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes: Death A life-threatening adverse event Inpatient hospitalization or prolongation of existing hospitalization A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions A congenital anomaly/birth defect. Important medical event
Measure:Phase II : Duration of Response
Time Frame:1 year
Safety Issue:
Description:Duration of response was calculated as duration between on-study date and best response date for those patients who achieved complete remission (CR) or partial response (PR)
Measure:Disease-free Survival
Time Frame:1 year
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:1 year
Safety Issue:
Description:
Measure:Time to Relapse/Progression
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Masonic Cancer Center, University of Minnesota

Last Updated

January 13, 2020