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Brief Title: Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Official Title: A Phase 1/2 Study of Copanlisib and Venetoclax in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study ID: NCT04939272
Brief Summary: This phase I/II trial studies the side effects, best dose, and effectiveness of copanlisib and venetoclax in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving copanlisib and venetoclax may help treat patients with mantle cell lymphoma.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the safety, tolerability, and the maximum tolerated dose (MTD) of copanlisib hydrochloride (copanlisib) and venetoclax in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). (Phase 1) II. To estimate the efficacy (as measured by overall rate of response \[ORR\]) of copanlisib in combination with venetoclax in patients with R/R MCL. (Phase 2) SECONDARY OBJECTIVES: I. To characterize the safety profile of copanlisib in combination with venetoclax in patients with R/R MCL. (Phase 2) II. To evaluate duration of response (DOR) and progression-free survival (PFS) associated with combined administration of copanlisib/venetoclax. (Phase 2) III. To evaluate an overall survival (OS) associated with combined administration of copanlisib/venetoclax. (Phase 2) IV. To characterize the pharmacokinetics (PK) profile of copanlisib and venetoclax. (Phase 2) EXPLORATORY OBJECTIVES: I. Evaluate the emergence of resistant clones, as determined by the presence of novel mutations and expression of BCL2 family proteins. II. Characterize the T-cell population balance in patients treated with copanlisib/venetoclax. OUTLINE: This is a phase I, dose-escalation study of copanlisib hydrochloride, followed by a phase II study. Patients receive copanlisib hydrochloride intravenously (IV) over 1 hour on days 1, 8, and 15, and venetoclax orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Medical Center, Duarte, California, United States
Name: Alexey Danilov
Affiliation: City of Hope Medical Cneter
Role: PRINCIPAL_INVESTIGATOR