Phase 2 Lymphoma Trial, Recruiting NCT07013565 Sponsor: New York Medical College Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT07013565
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who weigh at least 10 kilograms at the time of joining the study
  • People who have a confirmed type of lymphoma called ALK-positive anaplastic large cell lymphoma (ALK+ ALCL) that has come back or stopped responding to treatment
  • People who fall into the Low Risk group, meaning: the lymphoma came back more than one year after first being diagnosed, has a common tissue type, tests negative for a marker called CD3, and the person has never been treated with a drug called vinblastine
  • People who fall into the High Risk group, meaning: the lymphoma came back or got worse within one year of first being diagnosed, has a less common tissue type (small cell or histiocytic), and tests positive for CD3
  • People whose heart, liver, kidneys, and other organs are working well enough to safely take part (confirm with trial site)
  • People with a performance status score of 60 or above, which is a medical measure of how well a person is able to carry out daily activities (confirm with trial site)

Who may not be able to join:

  • People whose lymphoma tests negative for ALK (ALK-negative ALCL)
  • People who currently have lymphoma cells present in the fluid around the brain or spinal cord
  • People in the Low Risk group who have previously been treated with vinblastine
  • People who are currently pregnant — pregnancy testing is required for girls who have already started their periods
  • People who are currently breastfeeding, unless they have agreed to stop breastfeeding for the duration of the trial
  • People who have Down syndrome
  • People who have an infection that is not currently under control
  • People who have a known immune system disorder (whether present from birth or developed later) or who have previously received a solid organ transplant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mitchell S Cairo, MD, New York Medical College

Phone: 914-594-2150

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
New York Medical College
Registry
ClinicalTrials.gov
Start date
7 August 2025
Est. completion
1 July 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the incidence of adverse events (safety) of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV); To determine the overall response rate of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV).; To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.; To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.; To significantly improve the 1 year EFS in CAYA w...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov