Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas
A Phase Ia/Ib Study of a Novel BTK Inhibitor, DTRMWXHS-12, and Combination Products, DTRM-505 and DTRM-555, in Patients With Chronic Lymphocytic Leukemia or Other B-cell Lymphomas
1 other identifier
interventional
48
1 country
6
Brief Summary
This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in combination. This study will be conducted in two parts: phase Ia and Ib. Both parts will explore escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy. The phase Ib study will evaluate DTRMWXHS-12 combinations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2016
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2020
CompletedNovember 27, 2020
April 1, 2020
4.2 years
August 18, 2016
November 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events
Safety and tolerability
Starting from date of first dose up to 30 days after last dose
Secondary Outcomes (1)
Plasma concentration over time
Days 1-28 (first treatment cycle)
Study Arms (3)
Phase Ia
EXPERIMENTALDTRMWXHS-12: oral capsules, daily x 21 days every 28 days
Phase Ib, DTRM-505
EXPERIMENTALDTRMWXHS-12 oral capsules and everolimus oral tablets: daily x 21 days every 28 days
Phase Ib, DTRM-555
EXPERIMENTALDTRMWXHS-12 and pomalidomide oral capsules, everolimus oral tablets: daily x 21 days every 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of chronic lymphocytic leukemia (CLL) or other B-cell neoplasms including small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular B-cell non-Hodgkin's lymphoma (FL) who have no available approved therapies.
- Age \> 18 years.
- Life expectancy greater than 12 weeks.
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
- Patients must provide written informed consent.
- Ability to swallow and retain capsules.
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- Women of child-bearing potential must have a negative serum or urine pregnancy test.
- Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
- Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.
You may not qualify if:
- Received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days or 5 half-lives for targeted therapies prior to this study entry.
- Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptable
- Pregnant or lactating individuals.
- Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
- AST or ALT \> 2.5 x ULN
- Total bilirubin \> 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)
- Alkaline phosphatase \> 2.5 x ULN
- Glomerular filtration rate (GFR) \< 50 mL/min, as assessed using the standard methodology at the investigating center (i.e. Cockroft-Gault), or serum creatinine \> 1.5 x ULN
- INR \> 1.5 or other evidence of impaired hepatic synthesis function.
- Persisting (\> 8 weeks) severe pancytopenia due to hematologic disorder or due to previous therapy rather than disease (ANC \< 0.5 x 109/L or platelets \< 30 x 109/L) - to be confirmed via bone marrow biopsy, as part of normal clinical care, prior to signing of consent.
- Previous allogeneic bone marrow transplant are restricted, unless there is no evidence of acute or chronic graft versus host disease.
- CNS involvement with malignancy.
- Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.
- Known history of HIV, HBV or HCV infection.
- Documented or known bleeding disorder.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Yale Cancer Center
New Haven, Connecticut, 06510, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei He, Ph.D.
Zhejiang DTRM Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2016
First Posted
September 14, 2016
Study Start
September 1, 2016
Primary Completion
November 23, 2020
Study Completion
November 23, 2020
Last Updated
November 27, 2020
Record last verified: 2020-04