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NCT02158091 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL
A Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT02158091: Active Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Dana-Farber Cancer Institute.
NCT02158091 is a Phase 1 study of Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 32 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158091, a Phase 1 study of Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
To assess the safety of IPI145 in combination with FCR in previously untreated younger patients with CLL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 3 or greater hematologic toxicity (except Grade 3 or Grade 4 neutropenia or thrombocytopenia that lasts less than or equal to 10 days off treatment), any Grade 3 or greater non-hematologic toxicity (except Grade
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG IPI-145
Study Locations (2)
Massachusetts
- Beth Isreal Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-06-27 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT02158091 still lists
NCT02158091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02158091 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02158091 about?
NCT02158091 is a clinical study titled "A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL". 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).
What is the current status of trial NCT02158091?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-06-27. Estimated completion is 2026-07.
What conditions does trial NCT02158091 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT02158091?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), IPI-145 (DRUG).
Who is sponsoring clinical trial NCT02158091?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02158091 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02158091's enrollment target sits among peer trials
32 131st of 187 higher than 55 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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