Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas
NCT ID: NCT02900716
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2016-09-30
2020-11-23
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase Ia
DTRMWXHS-12: oral capsules, daily x 21 days every 28 days
DTRMWXHS-12
DTRMWXHS-12
Phase Ib, DTRM-505
DTRMWXHS-12 oral capsules and everolimus oral tablets: daily x 21 days every 28 days
DTRM-505
DTRMWXHS-12 and everolimus
Phase Ib, DTRM-555
DTRMWXHS-12 and pomalidomide oral capsules, everolimus oral tablets:
daily x 21 days every 28 days
DTRM-555
DTRMWXHS-12 and everolimus and pomalidomide
Interventions
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DTRMWXHS-12
DTRMWXHS-12
DTRM-505
DTRMWXHS-12 and everolimus
DTRM-555
DTRMWXHS-12 and everolimus and pomalidomide
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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:
1. AST or ALT \> 2.5 x ULN
2. 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)
3. Alkaline phosphatase \> 2.5 x ULN
4. 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.
* Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low molecular weight heparin and heparin line flush allowed).
* Patient is receiving any azole.
* Patients with a significant cardiovascular disease or condition, including:
* Myocardial infarction within 6 months of study entry
* NYHA Class III or IV heart failure, or reduced LVEF \<50%
* Uncontrolled dysrhythmias or poorly controlled angina.
* History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO).
18 Years
ALL
No
Sponsors
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Zhejiang DTRM Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Wei He, Ph.D.
Role: STUDY_DIRECTOR
Zhejiang DTRM Biopharma
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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D15-11094
Identifier Type: -
Identifier Source: org_study_id