- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370160
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center, University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DT2219ARL
A recombinant bispecific antibody-targeted toxin.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Day 1 - Day 29
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Phase ll: Overall Disease Response
Time Frame: Day 29
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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. |
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 1 year
|
1 year
|
|
Disease-free Survival
Time Frame: 1 year
|
1 year
|
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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:
|
Day 29
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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)
|
1 year
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Time to Relapse/Progression
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Veronika Bachanova, MD, PhD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014LS093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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