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Promising new combo aims to tame hodgkin lymphoma in young patients

NCT ID NCT07551583

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 6 times

Summary

This study tests whether adding nivolumab to standard chemotherapy (AVD) can better control early-stage Hodgkin lymphoma in patients aged 2 to 21. The treatment is given to 15 participants to see if it is safe and effective. The goal is to improve outcomes while reducing long-term side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 2 year to 21 years 2. Newly diagnosed early-stage (I/II) non-bulky (\<10cm) classical Hodgkin lymphoma 3. Baseline ejection fraction must be \> 40% 4. 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 involvement, in which case direct bilirubin \< 3x ULN or AST and/or ALT \< 5x ULN will be considered eligible) 5. Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease 6. ECOG performance status ≤2 (Karnofsky ≥60%,) (See Appendices) 7. 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 the prior therapy (whichever is shorter). Steroids for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI 8. 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better as classified by PI 9. Unless surgically or biologically sterile: Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months for males, and 6 months for females, after the last treatment The effects of this combination of chemotherapy on the developing human fetus are unknown. For this reason, these agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 10. Ability to understand and the willingness to sign a written informed consent document as detailed below and if minor, getting parental/guardian consent Exclusion Criteria: 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. symptomatic mediastinal mass) 1. Patients who weigh less than 10kg 2. Any severe allergy to any of the drugs (Nivo-AVD) 3. Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment 4. 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 5. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded 6. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of nivolumab. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection). 2. 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. 3. 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, vinblastine interactions) should be avoided. Multiple CYP3A4 interacting agents of moderate or strong effect in the HIV+ patients should not be used. This includes most HIV protease inhibitors. 13) Known active HIV and hepatitis B and hepatitis C (unless see below points (a)(b)). Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with prior hepatitis B and hepatitis C with are undetectable viral load are eligible for this trial. 14\) For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated a. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load 7\) Patients with psychiatric illness/social situations that would limit compliance with study requirements 8) Patients with a concurrent active malignancy under treatment 9) Pregnant women are excluded from this study because these agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UT MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.