Anaplastic Large Cell Lymphoma, ALK-PositivePhase 2ACCELERATENCT07013565
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
A Phase 2 study testing Vinblastine (Velban), Brentuximab vedotin (Adcetris) and Nivolumab (Opdivo) in people with Anaplastic Large Cell Lymphoma, ALK-Positive, run by New York Medical College at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 1 year to 39 years
- Conditions the study is for
- Anaplastic Large Cell Lymphoma, ALK-Positive
- What is being tested?
- Vinblastine (Velban), Brentuximab vedotin (Adcetris) and Nivolumab (Opdivo)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must weigh ≥10 kilograms at the time of study enrollment.
- Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:
- Low Risk Cohort (LR cohort):
- Any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
- Common histology,
- CD3 negative, AND
Show all 13Show fewer
- No prior exposure to vinblastine (VBL).
- High-Risk Cohort (HR cohort):
- Any patient with RELAPSED OR PROGRESSIVE DISEASE less than ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
- Small cell/histiocytic histology,
- CD3 positive (homogeneous staining of CD3 positive T-cells)
- Patients must have adequate organ function.
- Patients must have performance status 60 or above.
Who cannot join
- ALK-NEGATIVE anaplastic large cell lymphoma.
- Patients with active leptomeningeal disease (lymphoma cells in CSF).
- Previous treatment with vinblastine (only in patients in the LR cohort).
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarche.
- Lactating females unless they have agreed not to breastfeed their infants.
- Patients with Down syndrome.
- Any patient with uncontrolled infection prior to study entry.
- Any patient known to have primary or acquired immunodeficiency and/or prior solid organ transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Medical College
Valhalla, New York, 10595
Lauren Harrison, RN, MSN, 617-285-7844, lauren_harrison@nymc.edu
Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu
About this study
Official title: NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed/Refractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)
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.
Read the detailed description
Brief Background: A multitude of chemotherapeutic regimens have been evaluated for the treatment of de novo ALK+ ALCL. Unfortunately, no chemotherapeutic regimen has improved the 20-30% treatment failure rate. Given the ubiquitous cell surface expression of CD30 on ALK+ ALCL, the anti-CD30 antibody drug conjugate (ADC) brentuximab vedotin (BV) is a rational therapeutic agent for ALK+ ALCL. 16. In the most recent Children's Oncology Group (COG) trial for de novo ALK+ ALCL (ANHL12P1), BV was combined with ALCL99 chemotherapy and demonstrated the best reported outcomes with a 2-year event free survival and overall survival of 79% and 97% respectively. Immune checkpoint inhibition with antibodies that block the inhibitory immune receptors CTLA-4, PD-1, and PD-L1 have improved the outcomes for many patients with cancer by dramatically enhancing the anti-tumor activity of the immune system. Iwafuchi et al. demonstrated that elevated PD-1/PD-L1 expression was associated with a poor prognosis in pediatric ALK+ ALCL 22. Three different case reports have described dramatic responses (CR, CR, CR) to PD-1 inhibitors in heavily pre-treated patients with R/R ALK+ ALCL. The combination of BV and NIVO has been extensively tested in both pediatric and adult patients with R/R Hodgkin lymphoma and R/R primary mediastinal B-cell lymphoma with robust safety and efficacy. Given the frequent expression of both CD30 and PD-L1 in ALK+ ALCL, the impressive single agent therapeutic efficacy of both BV and NIVO, and the tolerability of the combination of BV and NIVO in other patients with lymphoma, investigating the safety and efficacy of BV and NIVO in R/R ALK+ ALCL is warranted. For pediatric patients with relapsed or refractory ALK-positive ALCL, remission can be achieved through the use of chemotherapy and/or immune therapy. However, the optimal treatment strategy for consolidative therapy in pediatric patients with relapsed or refractory ALK- positive ALCL remains to be determined. The literature reports High-risk patients with CD3-positive ALCL experiencing relapse at any time after first-line therapy achieved 5-year EFS and OS rates of 62 and 73%, respectively after reinduction therapy followed by best available donor allogeneic stem cell transplantation. Very high-risk patients with progression during first-line therapy achieved EFS and OS rates of 41 and 59%, respectively after reinduction therapy followed by best available donor allogeneic stem cell transplantation. For all evaluable patients, the 5-year EFS and OS rates were 53 and 78%, respectively. A major barrier to survival for pediatric patients with relapsed or refractory ALCL is progression of disease during reinduction therapy prior to stem cell transplantation, highlighting the importance of effective re-induction therapy. Limited toxicity associated with immune therapy in comparison to traditional cytotoxic chemotherapy may contribute to more rapid recovery, reduction in time to stem cell transplantation and improvement in performance score prior to stem cell transplantation. Through the use of allogeneic stem cell transplantation and donor lymphocyte infusion, a graft versus lymphoma effect has been suggested for pediatric patients with relapsed or refractory ALCL.
- Being tested
- Vinblastine (Velban), Brentuximab vedotin (Adcetris), Nivolumab (Opdivo)
- Keywords
- ALCL, Relapsed ALCL
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinblastine (Velban)Drug
Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity).
Brentuximab vedotin (Adcetris)Drug
Also called Nivolumab
HR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO [BV + NIVO] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO [BV + VBL + NIVO] once every 21 days
Nivolumab (Opdivo)Drug
Also called brentuximab vedodin, Vinblastine
High risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO [VBL + NIVO] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR/SD/PD, patient will receive [BV+VBL+NIVO] and subsequent therapy as defined for the HR2 cohort.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk ALK+ ALCL | Experimental | Low risk patients include any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,Common histology, CD3 negative, Minimum disseminated disease (MDD) negative at de novo diagnosis (if MDD known), AND No prior exposure to vinblastine (VBL). Receives: Drug: Vinblastine (Velban) |
| High Risk ALK+ ALCL (BV Naive) | Experimental | * Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
* Small cell/histiocytic histology,
* CD3 positive (homogeneous staining of CD3 positive T-cells)
* Second or later relapse,
* Induction failure during initial treatment for de novo ALK+ ALCL, OR
* Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known) Receives: Drug: Vinblastine (Velban); Drug: Brentuximab vedotin (Adcetris); Drug: Nivolumab (Opdivo) |
| High Risk ALK+ ALCL (with prior BV) | Experimental | * Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
* Small cell/histiocytic histology,
* CD3 positive (homogeneous staining of CD3 positive T-cells)
* Second or later relapse,
* Induction failure during initial treatment for de novo ALK+ ALCL, OR
* Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known) Receives: Drug: Vinblastine (Velban); Drug: Brentuximab vedotin (Adcetris); Drug: Nivolumab (Opdivo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
adverse events possible probably or definitely related to NIVO will be reported.
Measured: 1 year
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).
Patient will have disease assessments to determine best response to therapy with NIVO and Vinblastine
Measured: 1 year
To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.
adverse events probably or definitely related to NIVO will be collected.
Measured: 1 year
To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.
disease assessments will be performed to determine best response post therapy
Measured: 1 year
To significantly improve the 1 year EFS in CAYA with high-risk ALCL who received NIVO risk-adapted combining immunotherapy with re-induction followed by RTC and AlloHSCT compared to historical controls.
Events for EFS the first year will be reported and are defined as disease relapse, disease progression or toxic death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start7 Aug 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Large Cell Lymphoma, ALK-PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Helen DeVos Children's Hospital, Nationwide Children's Hospital, Memorial Sloan Kettering Cancer Center, University of Utah, Ohio State University, University of North Carolina, Children's Hospital of Philadelphia, Medical College of Wisconsin, Children's Hospital of Orange County
- Responsible party
- Sponsor
- Investigators
- Mitchell S Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013565
- Sponsor's protocol ID
- NYMC 623
- Acronym
- ACCELERATE
- Status last verified
- May 2026
- First submitted
- 6 May 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed/Refractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)
- ClinicalTrials.gov ID
- NCT07013565
- Acronym / sponsor ID
- ACCELERATE / NYMC 623
- Keywords
- ALCL, Relapsed ALCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Helen DeVos Children's Hospital, Nationwide Children's Hospital, Memorial Sloan Kettering Cancer Center, University of Utah, Ohio State University, University of North Carolina, Children's Hospital of Philadelphia, Medical College of Wisconsin, Children's Hospital of Orange County
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brief Background: A multitude of chemotherapeutic regimens have been evaluated for the treatment of de novo ALK+ ALCL. Unfortunately, no chemotherapeutic regimen has improved the 20-30% treatment failure rate. Given the ubiquitous cell surface expression of CD30 on ALK+ ALCL, the anti-CD30 antibody drug conjugate (ADC) brentuximab vedotin (BV) is a rational therapeutic agent for ALK+ ALCL. 16. In the most recent Children's Oncology Group (COG) trial for de novo ALK+ ALCL (ANHL12P1), BV was combined with ALCL99 chemotherapy and demonstrated the best reported outcomes with a 2-year event free survival and overall survival of 79% and 97% respectively. Immune checkpoint inhibition with antibodies that block the inhibitory immune receptors CTLA-4, PD-1, and PD-L1 have improved the outcomes for many patients with cancer by dramatically enhancing the anti-tumor activity of the immune system. Iwafuchi et al. demonstrated that elevated PD-1/PD-L1 expression was associated with a poor prognosis in pediatric ALK+ ALCL 22. Three different case reports have described dramatic responses (CR, CR, CR) to PD-1 inhibitors in heavily pre-treated patients with R/R ALK+ ALCL. The combination of BV and NIVO has been extensively tested in both pediatric and adult patients with R/R Hodgkin lymphoma and R/R primary mediastinal B-cell lymphoma with robust safety and efficacy. Given the frequent expression of both CD30 and PD-L1 in ALK+ ALCL, the impressive single agent therapeutic efficacy of both BV and NIVO, and the tolerability of the combination of BV and NIVO in other patients with lymphoma, investigating the safety and efficacy of BV and NIVO in R/R ALK+ ALCL is warranted. For pediatric patients with relapsed or refractory ALK-positive ALCL, remission can be achieved through the use of chemotherapy and/or immune therapy. However, the optimal treatment strategy for consolidative therapy in pediatric patients with relapsed or refractory ALK- positive ALCL remains to be determined. The literature reports High-risk patients with CD3-positive ALCL experiencing relapse at any time after first-line therapy achieved 5-year EFS and OS rates of 62 and 73%, respectively after reinduction therapy followed by best available donor allogeneic stem cell transplantation. Very high-risk patients with progression during first-line therapy achieved EFS and OS rates of 41 and 59%, respectively after reinduction therapy followed by best available donor allogeneic stem cell transplantation. For all evaluable patients, the 5-year EFS and OS rates were 53 and 78%, respectively. A major barrier to survival for pediatric patients with relapsed or refractory ALCL is progression of disease during reinduction therapy prior to stem cell transplantation, highlighting the importance of effective re-induction therapy. Limited toxicity associated with immune therapy in comparison to traditional cytotoxic chemotherapy may contribute to more rapid recovery, reduction in time to stem cell transplantation and improvement in performance score prior to stem cell transplantation. Through the use of allogeneic stem cell transplantation and donor lymphocyte infusion, a graft versus lymphoma effect has been suggested for pediatric patients with relapsed or refractory ALCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk ALK+ ALCL | Experimental | Drug: Vinblastine (Velban)Low risk patients include any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,Common histology, CD3 negative, Minimum disseminated disease (MDD) negative at de novo diagnosis (if MDD known), AND No prior exposure to vinblastine (VBL). |
| High Risk ALK+ ALCL (BV Naive) | Experimental | Drug: Vinblastine (Velban), Drug: Brentuximab vedotin (Adcetris), Drug: Nivolumab (Opdivo)* Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL, * Small cell/histiocytic histology, * CD3 positive (homogeneous staining of CD3 positive T-cells) * Second or later relapse, * Induction failure during initial treatment for de novo ALK+ ALCL, OR * Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known) |
| High Risk ALK+ ALCL (with prior BV) | Experimental | Drug: Vinblastine (Velban), Drug: Brentuximab vedotin (Adcetris), Drug: Nivolumab (Opdivo)* Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL, * Small cell/histiocytic histology, * CD3 positive (homogeneous staining of CD3 positive T-cells) * Second or later relapse, * Induction failure during initial treatment for de novo ALK+ ALCL, OR * Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known) |
Who may qualify
- Ages
- 1 year to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Patients must weigh ≥10 kilograms at the time of study enrollment.
- Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:
- Any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
- Common histology,
- CD3 negative, AND
Key exclusion criteria (8 listed)
- ALK-NEGATIVE anaplastic large cell lymphoma.
- Patients with active leptomeningeal disease (lymphoma cells in CSF).
- Previous treatment with vinblastine (only in patients in the LR cohort).
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarche.
- Lactating females unless they have agreed not to breastfeed their infants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinblastine (Velban)Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity). | Drug | High Risk ALK+ ALCL (BV Naive), High Risk ALK+ ALCL (with prior BV), Low-risk ALK+ ALCL |
| Brentuximab vedotin (Adcetris)Also: NivolumabHR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO [BV + NIVO] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO [BV + VBL + NIVO] once every 21 days | Drug | High Risk ALK+ ALCL (BV Naive), High Risk ALK+ ALCL (with prior BV) |
| Nivolumab (Opdivo)Also: brentuximab vedodin, VinblastineHigh risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO [VBL + NIVO] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR/SD/PD, patient will receive [BV+VBL+NIVO] and subsequent therapy as defined for the HR2 cohort. | Drug | High Risk ALK+ ALCL (BV Naive), High Risk ALK+ ALCL (with prior BV) |
Primary outcome
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)
Time frame: 1 year
adverse events possible probably or definitely related to NIVO will be reported.
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).
Time frame: 1 year
Patient will have disease assessments to determine best response to therapy with NIVO and Vinblastine
To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.
Time frame: 1 year
adverse events probably or definitely related to NIVO will be collected.
To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.
Time frame: 1 year
disease assessments will be performed to determine best response post therapy
To significantly improve the 1 year EFS in CAYA with high-risk ALCL who received NIVO risk-adapted combining immunotherapy with re-induction followed by RTC and AlloHSCT compared to historical controls.
Time frame: 1 year
Events for EFS the first year will be reported and are defined as disease relapse, disease progression or toxic death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell S Cairo, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinblastine (Velban), Brentuximab vedotin (Adcetris) and Nivolumab (Opdivo) in people with Anaplastic Large Cell Lymphoma, ALK-Positive, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell S Cairo, MD (914-594-2150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.