IPI-145 + FCR for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMatthew S. Davids

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

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).

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

I have been diagnosed with CLL and need treatment.

I have not received any treatment for chronic lymphocytic leukemia.

I am between 18 and 65 years old.

+1 more

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I've been cancer-free for 5 years, except for certain low-risk types.

+12 more

Participant Groups

The study tests a new drug called IPI-145 combined with standard CLL treatments: fludarabine, cyclophosphamide, and rituximab (FCR). It aims to see if adding IPI-145 improves outcomes for those who have never been treated for CLL before.

1Treatment groups

Experimental Treatment

Group I: IPI-145Experimental Treatment4 Interventions

Phase I-Dose escalation will occur using a standard 3-3 dose escalation beginning in dose level 1 with dose cohorts and escalation. * Each treatment cycle lasts 28 days (except cycle 1, which is 35 days) during which time IPI-145 will be taken twice daily. The study begins with 1 week of IPI-145 monotherapy. * Fludarabine, cyclophosphamide, rituximab (iFCR) - FCR will subsequently be introduced after 1 week and administered at standard dosing for up to 6 cycles, with dose reductions permitted. IPI-145 will be continued through the course of chemotherapy and for up to 2 years maintenance after completing chemotherapy Phase II - 20 additional patients treated with IPI-145 at the Recommended Phase II Dose (RP2D) + fludarabine, cyclophosphamide, rituximab (FCR) with standard dosing.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: