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ACTIVE NOT RECRUITING Phase 2

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

NCT07013565 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Vinblastine (Velban)
  • DRUG Brentuximab vedotin (Adcetris)
  • DRUG Nivolumab (Opdivo)

Study Locations (1)

New York

  • New York Medical College — Valhalla

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-08-07
Est. Completion 2030-07-01
Phase Phase 2

Sponsor

New York Medical College

50 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07013565

The ClinicalTrials.gov registry entry for NCT07013565 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07013565 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07013565?

The interventions under investigation include: Vinblastine (Velban) (DRUG), Brentuximab vedotin (Adcetris) (DRUG), Nivolumab (Opdivo) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07013565?

This trial is sponsored by New York Medical College, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial