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NCT07001384 · ClinicalTrials.gov registry record · Phase 1
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
A Phase 1 study of Anaplastic Large Cell Lymphoma and Anaplastic Lymphoma Kinase, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT07001384: Recruiting Phase 1 study of Anaplastic Large Cell Lymphoma and Anaplastic Lymphoma Kinase, sponsored by Memorial Sloan Kettering Cancer Center.
NCT07001384 is a Phase 1 study of Anaplastic Large Cell Lymphoma and Anaplastic Lymphoma Kinase that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 59-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (49% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07001384, a Phase 1 study of Anaplastic Large Cell Lymphoma and Anaplastic Lymphoma Kinase, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study Summary
The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. Once they find this dose combination, they will test it in a new group of participants to learn how long the effect of the combination lasts after the end of treatment
Primary Outcome
of alectinib (A) + duvelisib (D) The MTD will be defined as the dose level at which the estimated dose-limiting toxicity (DLT) rate from the CRM model is closest to the target acceptable rate of 25%.
Conditions Studied
Interventions
- DRUG Duvelisib
- DRUG Alectinib
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (LimitedProtocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-08-08 |
| Est. Completion | 2031-08-08 |
| Phase | Phase 1 |
What NCT07001384 shows while recruiting
NCT07001384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 59-participant average among 25 other Anaplastic Large Cell Lymphoma trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with Anaplastic Large Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Duvelisib is the first listed.
NCT07001384 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT07001384 about?
NCT07001384 is a clinical study titled "A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)". The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest do...
What is the current status of trial NCT07001384?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-08-08. Estimated completion is 2031-08-08.
What conditions does trial NCT07001384 study?
This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase.
What interventions are being tested in trial NCT07001384?
The interventions under investigation include: Duvelisib (DRUG), Alectinib (DRUG).
Who is sponsoring clinical trial NCT07001384?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07001384 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07001384's enrollment target sits among peer trials
30 12th of 25 higher than 13 of 25 other Anaplastic Large Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anaplastic Large Cell Lymphoma 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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