Study on RP-3500 and Olaparib for Treating Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia with DNA Repair Issues

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05405309

Provider View

This clinical trial is testing a combination of two drugs, RP-3500 and Olaparib, to see if they are safe and effective for patients with chronic lymphocytic leukemia (CLL) that has returned or is difficult to treat due to problems in DNA repair pathways.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with chronic lymphocytic leukemia (CLL) that has come back or is hard to treat. The treatment combines two drugs, RP-3500 and Olaparib, which target specific DNA repair issues in cancer cells. The study aims to find the safest and most effective dose of this combination and to see if it can help control the disease in patients with certain genetic mutations.

Description

The study is divided into two phases. In Phase Ib, researchers will test different doses of RP-3500 and Olaparib to find the safest dose that patients can tolerate. Up to 18 patients will be involved in this phase to determine the best dose. If the initial dose is too strong, it may be adjusted to ensure safety.

Once the best dose is found, the study will move to Phase II, where more patients will receive the treatment to see how well it works. This phase will include two groups of patients: one group with specific genetic changes (del(11q) and/or ATM mutation) and another group with other eligible patients. A total of 24 patients will participate in this phase.

The study will help determine if this combination of drugs can effectively treat CLL in patients with DNA repair issues, providing a new option for those who have not responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have a diagnosis of chronic lymphocytic leukemia (CLL) based on specific medical criteria.
  • Must have certain genetic mutations or deletions in their cancer cells, such as TP53, ATM, or deletion 17p13.
  • Must have tried at least two other treatments that did not work or are not expected to work long-term.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of at least 12 months.
  • Must have adequate blood cell counts and organ function, including kidney and liver function.
  • Must be able to swallow capsules and follow the study schedule.
  • Must agree to use effective contraception during the study and for six months after the last treatment.
  • Women must have a negative pregnancy test before starting the study.
  • Patients with HIV must have an undetectable viral load and be on stable antiretroviral therapy.

Exclusion Criteria

  • Currently taking another investigational drug.
  • Have received radiation or chemotherapy within two weeks before starting the study.
  • Have received immunotherapy or targeted therapy within two weeks before starting the study.
  • Have used certain medications that affect drug metabolism within a specified time before the study.
  • Have had major surgery within four weeks before starting the study.
  • Have active Richter's Transformation.
  • Have conditions requiring steroids at doses higher than 10mg of prednisone or equivalent.
  • Have had a stem cell transplant within a specified time before the study.
  • Have significant liver impairment.
  • Have another active cancer, except for certain non-threatening types.
  • Have active central nervous system involvement of CLL.
  • Have uncontrolled illnesses that could interfere with the study.
  • Have a history of severe allergic reactions to the study drugs.
  • Are pregnant or breastfeeding.
  • Have significant gastrointestinal issues affecting drug absorption.

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