Classical Hodgkin Lymphoma Clinical Trials

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A Phase II Single Arm Study to Evaluate Safety and Preliminary Efficacy of Nivolumab Plus AVD in Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-stage Non-bulky Classical Hodgkin Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients. The safety of this drug combination will also be studied.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 21
Healthy Volunteers: f
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• 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 involvement, in which case direct bilirubin \< 3x ULN or AST and/or ALT \< 5x ULN will be considered eligible)

• 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 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

• 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

• 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.

⁃ Ability to understand and the willingness to sign a written informed consent document as detailed below and if minor, getting parental/guardian consent

Locations
United States
Texas
UT MD Anderson
RECRUITING
Houston
Contact Information
Primary
David McCall, MD
dmccall1@mdanderson.org
(713) 792-6604
Time Frame
Start Date: 2026-08-19
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Phase II: Treatment with Nivolumab + AVD
Treatment will be administered on an inpatient and outpatient basis. Participants will be admitted for day 1 of chemotherapy for cycle 1 and evaluated for 1 or more days following chemotherapy as needed for tumor lysis or supportive care needs as directed by standard of care.
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov

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