Study on IPI-145 with FCR for Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02158091

Provider View

This clinical trial is testing a new drug, IPI-145, combined with standard chemotherapy drugs fludarabine, cyclophosphamide, and rituximab (FCR), to see if it can effectively treat younger patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug, IPI-145, when used with standard chemotherapy drugs (fludarabine, cyclophosphamide, and rituximab) in treating younger patients with chronic lymphocytic leukemia (CLL) who have not been treated before. The study is divided into two phases: Phase I aims to find the highest safe dose of the drug combination, while Phase II will use the recommended dose to further assess its effectiveness.

Description

Participants who meet the study requirements will receive the new drug IPI-145 along with the standard chemotherapy drugs fludarabine, cyclophosphamide, and rituximab (FCR). The study is conducted in two phases:

Phase I: The goal is to determine the highest dose of the drug combination that can be given safely without causing severe side effects. Participants may receive different doses based on how previous participants have responded.

Phase II: Participants will receive the recommended dose of IPI-145 along with the standard FCR treatment to further evaluate its effectiveness in treating CLL.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) and need for treatment.
  • No previous treatment for CLL.
  • Aged between 18 and 65 years.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Cannot be participating in another study or receiving other study drugs.
  • No known involvement of the central nervous system (CNS) by CLL.
  • No uncontrolled illnesses such as active infections, heart failure, unstable chest pain, irregular heartbeats, or mental health issues that would affect study participation.
  • Pregnant women cannot participate due to potential risks to the unborn baby.
  • No history of other cancers unless they have been disease-free for at least 5 years or have certain low-risk cancers treated within the past 5 years.
  • Cannot be HIV-positive due to potential drug interactions.
  • Must have adequate liver and kidney function as shown by specific blood tests.
  • Cannot have a prolonged QT interval on an ECG unless due to a specific heart condition.
  • Cannot be taking medications that affect the heart's electrical activity.
  • No history of active tuberculosis in the past two years.
  • No recent serious blood clots or bleeding issues.
  • No history of alcohol abuse or chronic liver disease.
  • Cannot be taking certain foods or medications that affect liver enzymes within a week before starting the study.
  • Must be able to receive preventive treatment for a specific type of pneumonia.

Locations

FACILITYZIPCITYSTATE
Beth Isreal Deaconess Medical Center02115BostonMassachusetts
Dana Farber Cancer Institute02115BostonMassachusetts

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