Clinical trial for Hodgkin Lymphoma
Official title Phase II Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL
ClinicalTrials.gov ID: NCT07551583
What this study is testing
What is Nivolumab?
An investigational intravenous medicine being studied for early‑stage Hodgkin lymphoma in children, teens, and young adults. It is designed to block a protein that helps cancer cells hide from the immune system.
Also referred to as Opdivo.
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
- The study wants to see if this drug combo can control newly diagnosed early-stage non‑bulky Hodgkin lymphoma and to check its safety.
- Who it's for
- Children, adolescents, and young adults newly diagnosed with early-stage non‑bulky Hodgkin lymphoma.
- What's involved
- Participants will receive the drug combination and have regular visits and tests to monitor response and side effects.
- Time commitment
- The study lasts about 6 months, with multiple clinic visits and blood tests during treatment.
- 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 2 to 21
You may be able to join if
- Age ≥ 2 year to 21 years
- Newly diagnosed early-stage (I/II) non-bulky (\<10cm) classical Hodgkin lymphoma
- Baseline ejection fraction must be \> 40%
- Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or lymphoma involvement...
- Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease
You likely can't join if
- 11) Patients who have received prior systemic therapy for the lymphoma with the exclusion of steroids for inflammatory conditions (e.g.
- Patients who weigh less than 10kg
- Any severe allergy to any of the drugs (Nivo-AVD)
- Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient...
- Patients who are receiving any other cancer directed investigational agents
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years.
See the full eligibility criteria
- Age ≥ 2 year to 21 years
- Newly diagnosed early-stage (I/II) non-bulky (\<10cm) classical Hodgkin lymphoma
- Baseline ejection fraction must be \> 40%
- Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or lymphoma involvement, and AST and/or ALT \< 3x ULN unless considered due to lymphoma...
- Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease
- ECOG performance status ≤2 (Karnofsky ≥60%,) (See Appendices)
- In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e.
- Ability to understand and the willingness to sign a written informed consent document as detailed below and if minor, getting parental/guardian consent
- 11) Patients who have received prior systemic therapy for the lymphoma with the exclusion of steroids for inflammatory conditions (e.g. asthma) or greater than 72 hours of emergent steroids (e.g.
- Patients who weigh less than 10kg
- Any severe allergy to any of the drugs (Nivo-AVD)
- Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment
- Patients who are receiving any other cancer directed investigational agents; The use of other chemotherapeutic agents or anti-lymphoma agents is not permitted during study
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years.
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
- The use of stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted for medical conditions needing systemic steroids.
- Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication 12) The use of strong inhibitors or inducers of CYP1A2 (dacarbazine interaction) or CYP3A4 (doxorubicin...
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, 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, but 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, 2 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.