Spots Global Cancer Trial Database for A Phase I Study of AC0010 in Patients With CLL/ SLL, MCL, DLBCL and Other NHL
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Trial Identification
Brief Title: A Phase I Study of AC0010 in Patients With CLL/ SLL, MCL, DLBCL and Other NHL
Official Title: A Phase I Study of AC0010 in Patients With Relapsed or Refractory CLL/SLL, MCL, DLBCL and Other Non-Hodgkin B-Cell Lymphoma
Study ID: NCT03060850
Conditions
Interventions
Study Description
Brief Summary: This is an open label, dose escalation, phase I study to determine the recommended Phase 2 dose (PR2D) by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma.
Detailed Description: This is an open label, dose escalation, phase I study to determine the PR2D by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell lymphoma. This study includes two parts. During Part 1 Dose Escalation, the "3+3" design will be applied. Dose escalation will begin at dose level 1 = 400 mg. This dose escalation will be followed by an exploratory expansion phase in 3 or 4 groups of 15\~41 patients each (CLL group, MCL group, non-germinal center B cell-like DLBCL group, and/or FL/WM(macroglobulinemia) group). The study will further evaluate the safety and efficacy of AC0010 in these patients in each group
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking Union Medical College Hospital, Beijing, Beijing, China
The First Affiliated Hospital,Zhejiang University, Hangzhou, Zhejiang, China
Contact Details
Name: Jie Jin, MD
Affiliation: The First Affiliated Hospital, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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