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New treatment option for Anaplastic Large Cell Lymphoma, ALK-Positive
Official title Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
ClinicalTrials.gov ID: NCT07013565
What this study is testing
What is Vinblastine (Velban)?
Vinblastine (Velban) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anaplastic large cell lymphoma, alk-positive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- 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...
- Any patient with FIRST RELAPSE \> ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
- Common histology,
- CD3 negative, AND
You likely can't join if
- 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.
See the full eligibility criteria
- 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.