IPI-145 + FCR for Chronic Lymphocytic Leukemia
Trial Summary
What is the purpose of this trial?
This research study is evaluating a new drug called IPI-145 in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR), as a possible treatment for chronic lymphocytic leukemia (CLL).
Will I have to stop taking my current medications?
The trial requires that you stop taking foods or medications that strongly affect CYP3A enzymes (which help process drugs in the body) at least one week before starting the study and throughout its duration.
What data supports the effectiveness of the drug combination IPI-145 + FCR for Chronic Lymphocytic Leukemia?
Research shows that the combination of fludarabine, cyclophosphamide, and rituximab (FCR) is highly effective for treating chronic lymphocytic leukemia, with a 95% overall response rate and 72% complete remission in patients. This suggests that adding IPI-145 to this regimen could potentially enhance its effectiveness.12345
Is the combination of IPI-145, fludarabine, cyclophosphamide, and rituximab safe for humans?
The combination of fludarabine, cyclophosphamide, and rituximab (FCR) has been shown to cause significant blood-related side effects, such as myelosuppression (a decrease in bone marrow activity leading to fewer blood cells), which can lead to infections and other complications. This treatment is generally less well tolerated in older patients, especially those over 70 years old.678910
What makes the IPI-145 + FCR drug unique for treating chronic lymphocytic leukemia?
The IPI-145 + FCR drug is unique because it combines a novel agent, IPI-145, with the established FCR regimen (fludarabine, cyclophosphamide, and rituximab), potentially enhancing the treatment's effectiveness while aiming to reduce the high toxicity levels associated with traditional FCR therapy.1351112
Research Team
Matthew S. Davids
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for younger patients aged 18-65 with confirmed chronic lymphocytic leukemia (CLL) who need treatment but haven't had any yet. They should be relatively healthy, not pregnant, and free from other cancers unless it's low-risk or treated within the past 5 years. People with poor liver or kidney function, heart issues, certain infections or diseases like HIV are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose escalation to find the highest safe dose of IPI-145 in combination with FCR
Phase II Treatment
Treatment with IPI-145 at the Recommended Phase II Dose (RP2D) in combination with FCR
Maintenance
IPI-145 maintenance therapy for up to 2 years after completing chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Fludarabine
- IPI-145
- Rituximab
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Verastem, Inc.
Industry Sponsor
Secura Bio, Inc.
Industry Sponsor