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NCT07013565 · ClinicalTrials.gov registry record · Phase 2
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
A Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive, sponsored by New York Medical College.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07013565: Active Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive, sponsored by New York Medical College.
NCT07013565 is a Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive that is active but no longer recruiting, run by New York Medical College. The registered enrollment target is 20 participants, below the 65-participant average among 4 other Anaplastic Large Cell Lymphoma, ALK-Positive trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07013565, a Phase 2 study of Anaplastic Large Cell Lymphoma, ALK-Positive, is active but no longer recruiting, sponsored by New York Medical College.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Children, adolescents, and young adults (CAYA) with relapsed/refractory (R/R) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of overall survival. This clinical trial will investigate if a new FDA approved medication called Nivolumab (NIVO) (which is a checkpoint blockade immunotherapy) combined with chemotherapy based on the patients risk status to get the patient into the best response possible. Then patients will receive lower doses of chemoimmunotherapy and allogeneic stem cell transplantation (stem cells from another person). The investigators this this new treatment will improve survival rates in this high-risk population of patients.
Primary Outcome
adverse events possible probably or definitely related to NIVO will be reported.
Conditions Studied
Interventions
- DRUG Vinblastine (Velban)
- DRUG Brentuximab vedotin (Adcetris)
- DRUG Nivolumab (Opdivo)
Study Locations (1)
New York
- New York Medical College - Valhalla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-08-07 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 2 |
What the registry record for NCT07013565 still lists
NCT07013565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 65-participant average among 4 other Anaplastic Large Cell Lymphoma, ALK-Positive trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Anaplastic Large Cell Lymphoma, ALK-Positive appearing as the primary indexed condition, and to 3 interventions - of which Vinblastine (Velban) is the first listed.
NCT07013565 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07013565 about?
NCT07013565 is a clinical study titled "Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL". Children, adolescents, and young adults (CAYA) with relapsed/refractory (R/R) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of overall survival. This clinical trial will investigate if a new FDA approved medication called Nivolumab (NIVO) (which is a checkpoint blockade i...
What is the current status of trial NCT07013565?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-08-07. Estimated completion is 2030-07-01.
What conditions does trial NCT07013565 study?
This clinical trial studies the following conditions: Anaplastic Large Cell Lymphoma, ALK-Positive.
What interventions are being tested in trial NCT07013565?
The interventions under investigation include: Vinblastine (Velban) (DRUG), Brentuximab vedotin (Adcetris) (DRUG), Nivolumab (Opdivo) (DRUG).
Who is sponsoring clinical trial NCT07013565?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07013565 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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