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

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ClinicalTrials.gov Identifier: NCT02370160
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 18, 2015
First Posted Date  ICMJE February 24, 2015
Last Update Posted Date September 27, 2018
Actual Study Start Date  ICMJE December 21, 2015
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • 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
  • Phase ll: Overall disease response [ Time Frame: Day 29 ]
    Response is defined as complete response, partial response and stable disease.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
  • Incidence of any grade 3 or 4 adverse event attributed to DT2219ARL [ Time Frame: Day 35 ]
    Phase I
  • Overall disease response [ Time Frame: Day 29 ]
    Phase II extension
Change History Complete list of historical versions of study NCT02370160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • 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
  • Duration of response [ Time Frame: 1 year ]
  • Disease-free survival [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
  • Time to relapse/progression [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
  • Incidence of serious adverse events [ Time Frame: Day 35 ]
  • Duration of response [ Time Frame: 1 year ]
  • Disease-free survival [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
  • Time to relapse/progression [ Time Frame: 1 year ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
Official Title  ICMJE HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory B-Lineage Leukemia
  • Relapsed B-Lineage Leukemia
  • Refractory B-Lineage Lymphoma
  • Relapsed B-Lineage Lymphoma
Intervention  ICMJE Biological: DT2219ARL
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.
Study Arms Experimental: DT2219ARL
A recombinant bispecific antibody-targeted toxin.
Intervention: Biological: DT2219ARL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2015)
44
Actual Study Completion Date March 8, 2018
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Active Hepatitis B or Hepatitis C (virus detectable by PCR)
  • Documented penicillin or cephalosporin allergies
  • Pregnant or lactating
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02370160
Other Study ID Numbers  ICMJE 2014LS093
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Veronika Bachanova, MD, PhD Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP