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

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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
DT2219ARLExperimentalA recombinant bispecific antibody-targeted toxin.

    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 109/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

    - 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:Duration of response
    Time Frame:1 year
    Safety Issue:
    Description:
    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:Recruiting
    Lead Sponsor:Masonic Cancer Center, University of Minnesota

    Trial Keywords

      Last Updated

      February 22, 2017