Study on the Safety and Effectiveness of Pembrolizumab with Chemotherapy in Children and Young Adults with Classical Hodgkin Lymphoma
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT03407144
This clinical trial is testing the safety and effectiveness of the drug pembrolizumab, combined with chemotherapy, in children and young adults who have been newly diagnosed with classical Hodgkin Lymphoma and are slow to respond to initial chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate how safe and effective pembrolizumab, when used with chemotherapy, is for treating children and young adults with classical Hodgkin Lymphoma (cHL) who do not respond quickly to initial chemotherapy. Participants are divided into two groups based on their risk level: Group 1 includes those with lower-risk stages of cHL, while Group 2 includes those with higher-risk stages.
Description
Participants in this study are divided into two groups based on the stage and risk level of their Hodgkin Lymphoma. Group 1 includes those with lower-risk stages (IA, IB, and IIA) without large tumors. Group 2 includes those with higher-risk stages (IIEB, IIIEA, IIIEB, IIIB, IVA, and IVB). The study will assess how well pembrolizumab, combined with chemotherapy, works in these groups.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with classical Hodgkin Lymphoma (cHL) at specific stages: Group 1 (Stages IA, IB, IIA without large tumors) or Group 2 (Stages IIEB, IIIEA, IIIEB, IIIB, IVA, IVB).
- Have measurable disease as determined by the study doctor.
- Male participants must agree to avoid donating sperm and use contraception or abstain from heterosexual intercourse during the study.
- Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for 120 days after the last dose.
- Must have a performance status score of at least 50 on the Lansky Play-Performance Scale (for children up to 16) or the Karnofsky score (for those 16 and older).
- Must have adequate organ function.
Exclusion Criteria
- Have had a solid organ transplant or a stem cell transplant in the last 5 years.
- Positive pregnancy test for women of childbearing potential within 24 hours before starting the study.
- Heart function below specific levels.
- Previous treatment with pembrolizumab or similar drugs.
- Have received any cancer treatment or investigational drugs for the current diagnosis before joining the study.
- Have received a live vaccine within 30 days before starting the study.
- Have a different type of Hodgkin Lymphoma (lymphocyte-predominant).
- Have an immune deficiency or are on long-term steroid therapy.
- Have another active cancer or have had one in the last 3 years.
- Have cancer that has spread to the brain or spinal cord.
- Severe allergy to study drugs.
- Have an autoimmune disease needing treatment in the last 2 years.
- Have lung disease requiring steroids or current lung disease.
- Have an active infection needing treatment.
- Have HIV, Hepatitis B, or active Hepatitis C.
- Have any condition that could interfere with the study or is not in the participant's best interest.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Have not recovered from major surgery or have ongoing surgical issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama ( Site 0023) | 35233 | Birmingham | Alabama |
| Phoenix Childrens Hospital ( Site 0034) | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital ( Site 0046) | 72202 | Little Rock | Arkansas |
| Kaiser - Orange County ( Site 0084) | 92806 | Anaheim | California |
| Kaiser Permanente ( Site 0082) | 90242 | Downey | California |
| Kaiser - Fontana ( Site 0083) | 92335 | Fontana | California |
| MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si | 90806 | Long Beach | California |
| Kaiser Permanente Downey Medical Center ( Site 0024) | 90027 | Los Angeles | California |
| Kaiser Permanente - Oakland ( Site 0047) | 94611 | Oakland | California |
| Kaiser Permanente - Roseville ( Site 0080) | 95661 | Roseville | California |
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