New combo aims to wipe out leukemia cells in younger patients
NCT ID NCT02158091
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new targeted drug, IPI-145, added to standard chemotherapy and immunotherapy (FCR) for younger adults (18-65) with untreated chronic lymphocytic leukemia (CLL). The goal is to see if the combination is safe and can achieve deep remissions where no cancer cells are detectable. Only 32 participants are enrolled, and the trial is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IPI-145 (a targeted drug) combined with fludarabine, cyclophosphamide, and rituximab (standard chemotherapy and immunotherapy)
- What this could lead to
- If this combination works, it could lead to deeper remissions and longer disease control for younger patients with chronic lymphocytic leukemia.
- What could go wrong
- This is an early-phase trial with only 32 participants, so results may not apply broadly. The added drug IPI-145 could increase side effects like infections or organ toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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32 people
The number who actually took part.
- Started
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Jun 2014
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * confirmed diagnosis of CLL and an indication for treatment as per IW-CLL 2008 criteria * no prior therapy for CLL * age 18-65 -- ECOG performance status ≤1 Exclusion Criteria: * May not be receiving any other study agents * Known CNS involvement * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because IPI-145 has the potential for teratogenic or abortifacient effects. * Individuals with a history of a different malignancy are ineligible except for the following circumstances. disease-free for at least 5 years and deemed to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated with curative intent within the past 5 years: cervical cancer in situ, localized prostate cancer, and basal cell or squamous cell carcinoma of the skin * HIV-positive individuals, because of the potential for pharmacokinetic interactions with IPI-145 * Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN); direct bilirubin \>1.5 x ULN, unless due to hemolysis or Gilbert's syndrome * Inadequate renal function defined by serum creatinine \>1.5 x ULN. * Baseline QTcF \>480 ms. NOTE: This criterion does not apply to patients with a left bundle branch block * Concurrent treatment with any agent known to prolong the QTc interval * Patients with a history of active tuberculosis within the preceding two years. * Patients who have had a venous thromboembolic event (e.g., PE/DVT) requiring anticoagulation and who meet any of the following criteria: * Have been on a stable dose of anticoagulation for \<1 month * Have had a Grade 2, 3 or 4 hemorrhage in the last 30 days * Are experiencing continued symptoms from their event * History of alcohol abuse, chronic hepatitis, or other chronic liver disease (other than direct CLL liver involvement) * Foods or medications that are strong or moderate inhibitors or inducers of CYP3A taken within 1 week prior to study treatment and for the duration of the study * Unable to receive prophylactic treatment for pneumocystis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02115, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?