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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 : Recruiting
First Posted : February 24, 2015
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Refractory B-Lineage Leukemia Relapsed B-Lineage Leukemia Refractory B-Lineage Lymphoma Relapsed B-Lineage Lymphoma Biological: DT2219ARL Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
Actual Study Start Date : December 21, 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
Experimental: DT2219ARL
A recombinant bispecific antibody-targeted toxin.
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.




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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. Duration of response [ Time Frame: 1 year ]
  3. Disease-free survival [ Time Frame: 1 year ]
  4. Overall survival [ Time Frame: 1 year ]
  5. Time to relapse/progression [ Time Frame: 1 year ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Active Hepatitis B or Hepatitis C (virus detectable by PCR)
  • Documented penicillin or cephalosporin allergies
  • Pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370160


Contacts
Contact: Timothy Krepski, RN 612-273-2800 tkrepsk1@fairview.org

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Timothy Krepski    612-273-2800    tkrepsk1@fairview.org   
Principal Investigator: Veronika Bachanova, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Veronika Bachanova, MD, PhD Masonic Cancer Center, University of Minnesota

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02370160     History of Changes
Other Study ID Numbers: 2014LS093
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases