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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DT2219ARL
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory B-Lineage Leukemia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DT2219ARL

Arm Description

A recombinant bispecific antibody-targeted toxin.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Incidence of Serious Adverse Events
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
Phase II : Duration of Response
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)
Disease-free Survival
Overall Survival
Time to Relapse/Progression

Full Information

First Posted
February 18, 2015
Last Updated
December 27, 2019
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02370160
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2015 (Actual)
Primary Completion Date
April 8, 2018 (Actual)
Study Completion Date
April 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory B-Lineage Leukemia, Relapsed B-Lineage Leukemia, Refractory B-Lineage Lymphoma, Relapsed B-Lineage Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DT2219ARL
Arm Type
Experimental
Arm Description
A recombinant bispecific antibody-targeted toxin.
Intervention Type
Biological
Intervention Name(s)
DT2219ARL
Intervention Description
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 Outcome Measure Information:
Title
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
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
Time Frame
Day 1 - Day 29
Title
Phase ll: Overall Disease Response
Description
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.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Incidence of Serious Adverse Events
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
Time Frame
Day 29
Title
Phase II : Duration of Response
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)
Time Frame
1 year
Title
Disease-free Survival
Time Frame
1 year
Title
Overall Survival
Time Frame
1 year
Title
Time to Relapse/Progression
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronika Bachanova, MD, PhD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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