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Completed

NCT Number: NCT02370160

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 1 - Day 29

    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

  2. Phase ll: Overall Disease Response

    Time frame: Day 29

    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.

Secondary outcomes

  1. Incidence of Serious Adverse Events

    Time frame: Day 29

    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

  2. Phase II : Duration of Response

    Time frame: 1 year

    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)

  3. Disease-free Survival

    Time frame: 1 year

  4. Overall Survival

    Time frame: 1 year

  5. Time to Relapse/Progression

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2015
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.