Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dizal Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female participants who have provided ICF with age ≥ 18 yrs
2. ECOG performance 0-2, no deterioration in the past 2 weeks
3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
4. Adequate bone marrow reserve and organ system functions
5. Participants willing to comply with contraceptive restrictions
You may not be if
1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
2. Prior history of allogeneic hematopoietic stem cell transplantation
3. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
4. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
6. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
7. Participants with infectious disease:
8. Clinically significant cardiac disorders or abnormalities
9. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
10. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
11. Women who are breast feeding
12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
