Study on Copanlisib and Venetoclax for Treating Relapsed or Hard-to-Treat Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT04939272

Provider View

This clinical trial is testing the safety, best dose, and effectiveness of combining two drugs, copanlisib and venetoclax, to treat mantle cell lymphoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

This study is exploring whether the combination of two drugs, copanlisib and venetoclax, can help treat patients with mantle cell lymphoma that has come back or is not responding to other treatments. Copanlisib works by blocking certain enzymes that cancer cells need to grow, while venetoclax blocks a protein that helps cancer cells survive. The trial aims to find the safest and most effective dose of these drugs and to see how well they work together in shrinking tumors.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of copanlisib and venetoclax for patients with relapsed or refractory mantle cell lymphoma. In Phase II, they will evaluate how effective this combination is in treating the cancer.

Participants will receive copanlisib through an IV on specific days and take venetoclax pills daily over a 28-day cycle. This treatment cycle can be repeated for up to 26 cycles unless the cancer progresses or side effects become too severe.

The study will also look at how long the treatment keeps the cancer from getting worse and how long patients live after receiving the treatment. Researchers will monitor the safety of the drug combination and study how the drugs are processed in the body. They will also explore how the cancer cells might develop resistance to the treatment and how the immune system responds to the drugs.

After finishing the treatment, participants will have follow-up visits every three months for two years to monitor their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of mantle cell lymphoma with specific markers or genetic changes.
  • The cancer must have returned or not responded to previous treatments.
  • Must have received at least one prior treatment for mantle cell lymphoma.
  • Must have measurable cancer that can be tracked by scans or tests.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must be able to take oral medication.
  • Must not have active infections like HIV or hepatitis.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days after the last dose.
  • Must agree to provide a tumor sample if available and sign an informed consent form.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have previously been treated with venetoclax or copanlisib.
  • Have had a stem cell transplant from a donor.
  • Have received certain cancer treatments recently, such as antibodies, radiation, or chemotherapy.
  • Have been vaccinated with live vaccines within four weeks of starting the study.
  • Are taking high doses of steroids or certain other medications that affect the liver.
  • Have cancer that has spread to the brain or central nervous system.
  • Have uncontrolled infections or unresolved side effects from previous treatments.
  • Have a history of other cancers unless they have been treated and are not active.
  • Have had major surgery recently.
  • Have significant heart or lung problems, uncontrolled high blood pressure, or diabetes.
  • Have had recent blood clots or strokes.
  • Are allergic to the study drugs or their ingredients.
  • Are pregnant or breastfeeding.
  • Have any other condition that would make participating in the study unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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