Phase
Condition
Neoplasms
Treatment
ICP-248
Rituximab (R)
Obinutuzumab (G)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Age ≥ 18.
Subjects with histopathologically and/or flow cytometry-confirmed diseases accordingto the 2016 World Health Organization (WHO) classification criteria forlymphohematopoietic neoplasms or meeting the International Workshop on ChronicLymphocytic Leukemia (iwCLL) criteria: relapsed or refractory CLL/SLL, relapsed orrefractory MCL. Patients must have received at least two prior lines of adequatesystemic therapy before study entry, and at least one prior systemic therapy shouldinclude Bruton's kinase inhibitor (BTKi).
For subjects with R/R MCL: Patients must have measurable disease per the Lugano 2014criteria.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS)score of ≤ 1 and a life expectancy of ≥ 6 months.
Adequate hematologic, hepatic, renal, pulmonary and cardiac function
Patients with basically normal coagulation function
Patients with fertility potential and their partners need contraception
Subjects can communicate with the investigator well and to complete the study asspecified in the study.
Exclusion
Exclusion Criteria:
Known central nervous system involvement by lymphoma/leukemia.
Known or suspected history of Richter's transformation.
Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or priorchimeric cell therapy (unless ≥ 3 months since cell infusion).
A history of allogeneic stem cell transplantation.
An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to thefirst dose of the investigational product, or a plan to use concurrentlymedications, dietary supplements or food (e.g., grapefruit or grapefruit juice) withstrong CYP3A or CYP2C8 inhibitory or inductive effect during study participation
Presence of active infection that currently requires intravenous systemicanti-infective therapy.
History of immunodeficiency, including a positive human immunodeficiency virus (HIV)antibody test.
History of significant cardiovascular disease
Patients with previous or concomitant central nervous system disorders
Grade 2 or above toxicity due to prior anti-cancer therapy at screening
Known alcohol or drug dependence
Unable to swallow tablets or presence of disease significantly affectinggastrointestinal function such as malabsorption syndrome, resection of the stomachor small bowel, bariatric surgery procedures, symptomatic inflammatory boweldisease, or partial or complete bowel obstruction.
Study Design
Connect with a study center
Pan American Center for Oncology Trials
San Juan, 00935
Puerto RicoActive - Recruiting
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, 18009
UkraineActive - Recruiting
CNE"City Clin Hosp#4"of Dnipro City Council
Dnipro, 49102
UkraineActive - Recruiting
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, 2091
UkraineActive - Recruiting
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, 1135
UkraineActive - Recruiting
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, 79057
UkraineActive - Recruiting
BRCR Medical Center
Plantation, Florida 33322
United StatesActive - Recruiting
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.