Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04939272
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copanlisib Hydrochloride — DRUG
    Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 for each cycle. Copanlisib will be given at 30mg, 45mg, or 60 mg depending on the assigned dose level.
  • Venetoclax — DRUG
    Patients receive venetoclax PO QD on days 1-28 for each cycle. Venetoclax will have a weekly dose ramp up in cycle one from 20mg, 50mg, 100mg, 200mg, and then 400mg daily thereafter starting from cycle 2.

Study Details

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.

Key Dates

Start date
Jun 29, 2022
Status verified
Apr 2026
Primary completion
Feb 12, 2027
Completion
Feb 12, 2027

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (copanlisib hydrochloride, venetoclax)
    Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15, and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Copanlisib will be given at 30mg, 45mg, or 60 mg depending on the assigned dose level. Venetoclax will have a weekly dose ramp up from 20mg, 50mg, 100mg, 200mg, and then 400mg thereafter.

Primary Outcome Measure

Incidence of dose limiting toxicities (Phase I) [ Time Frame: Up to end of cycle 2 (1 cycle = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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