Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zhejiang DTRM Biopharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
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).
Clareo Health | Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas
