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NCT03740334 · ClinicalTrials.gov registry record · Phase 1
Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL
A Phase 1 study of Acute Lymphoblastic Leukemia (ALL), sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 12
- Study locations
NCT03740334: Active Phase 1 study of Acute Lymphoblastic Leukemia (ALL), sponsored by Dana-Farber Cancer Institute.
NCT03740334 is a Phase 1 study of Acute Lymphoblastic Leukemia (ALL) that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 45 participants, below the 6,303-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740334, a Phase 1 study of Acute Lymphoblastic Leukemia (ALL), is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 12
- Study locations
Study Summary
This research study is evaluating a drug called ribociclib (LEE011) given in combination with everolimus and other standard of care chemotherapy drugs as a possible treatment for relapsed or refractory ALL. The names of the drugs involved in this study are: * ribociclib * everolimus * dexamethasone
Primary Outcome
Blood samples obtained for Pharmacokinetic (PK) analysis will be used to describe how study drugs are distributed and metabolized by human subjects. Samples for PK analysis will be obtained during Cycle 1 of all Cohorts. Area under the concentration-time curve from time zero to 24 hours (AUC(0-24hr)) is a measure of a subject's exposure to study drugs.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Dexamethasone
- DRUG Ribociclib
Study Locations (12)
Massachusetts
- Boston Children's Hospital - Boston
- Dana Farber Cancer Institute - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours/Alfred I. duPont Hospital for Children - Wilmington
Georgia
- Children's Healthcare of Atlanta - Atlanta
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
What the registry record for NCT03740334 still lists
NCT03740334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 6,303-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 3 interventions - of which Everolimus is the first listed.
NCT03740334 lists 12 locations in 9 states (Massachusetts, New York, Colorado).
Frequently Asked Questions
What is clinical trial NCT03740334 about?
NCT03740334 is a clinical study titled "Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL". This research study is evaluating a drug called ribociclib (LEE011) given in combination with everolimus and other standard of care chemotherapy drugs as a possible treatment for relapsed or refractory ALL. The names of the drugs involved in this study are: * ribociclib * everolimus * dexamethason...
What is the current status of trial NCT03740334?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-01-30. Estimated completion is 2026-10-01.
What conditions does trial NCT03740334 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia (ALL).
What interventions are being tested in trial NCT03740334?
The interventions under investigation include: Everolimus (DRUG), Dexamethasone (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT03740334?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740334 being conducted?
This trial has 12 study locations across Colorado, Delaware, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia (ALL)
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 NCT03740334's enrollment target sits among peer trials
45 10th of 16 higher than 7 of 16 other Acute Lymphoblastic Leukemia (ALL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia (ALL) 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.
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