First line chemotherapy for Hodgkin Lymphoma in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of three different chemotherapy approaches for treating classical Hodgkin Lymphoma in adult patients in Russia. It involves a non-randomized, open-label, multicenter design, focusing on early favorable, early unfavorable, and advanced stages of the disease. Patients will receive various treatment regimens based on their PET scan results after initial chemotherapy courses, which may include standard ABVD chemotherapy and potential radiotherapy or high-dose chemotherapy with stem cell transplantation. The study aims to improve progression-free survival and overall treatment outcomes for Hodgkin Lymphoma patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed classical HL
* Previously untreated disease
* Age 18-5 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
* Adequate organ and marrow function as defined below: absolute neutrophil count \>1,0 x109/L, platelets \>75 x109/L
* Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome
* Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2
* Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception
* Life expectancy \> 6 months
* Able to adhere to the study visit schedule and other protocol requirements
* Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Access to PET-CT (positron emission computed tomography) scans facilities

Exclusion Criteria:

* Nodular Lymphocyte Predominant HL
* Prior chemotherapy or radiation therapy
* Pregnant or lactating females
* Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
* Abnormal QTc (corrected QT interval) interval prolonged (\>450 msec in males; \>470 msec in women)
* Uncontrolled infectious disease
* Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided
* Uncompensated diabetes
* Refusal of adequate contraception
* Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Where it's running

• Tata Memorial Hospital
  Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012, India Recruiting
• The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Vladislav Sarzhevskiy, PhD — State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Study coordinator: Vladislav Sarzhevskiy, PhD
• Email: vladsar100@gmail.com
• Phone: +7-910-436-00-40

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ctDNA-guided therapy for relapsed or refractory Hodgkin lymphoma using pembrolizumab with GVD

  This study tests a pembrolizumab-based regimen plus chemotherapy in adults with relapsed or refractory classic Hodgkin lymphoma to see if ctDNA can guide treatment response and consolidation choices.

  Recruiting Phase 2 University of California, San Francisco · Davis, California and 5 other locations · NCT07021989

• Using nivolumab with AVD for advanced Hodgkin lymphoma

  This study is testing if a new combination of nivolumab and AVD chemotherapy can help people with newly diagnosed advanced Hodgkin lymphoma feel better and respond well to treatment.

  Recruiting Phase 2 National Medical Research Radiological Centre of the Ministry of Health of Russia · Moscow · NCT06984146

• Understanding brain function in Hodgkin Lymphoma survivors

  This study is trying to see how treatments for Hodgkin Lymphoma affect brain function in survivors compared to people who haven't had cancer.

  Recruiting St. Jude Children's Research Hospital · Memphis, Tennessee · NCT06421987

• Evaluating MT-601 for patients with relapsed or refractory lymphoma

  This study is testing a new treatment called MT-601 to see if it can help people with relapsed or hard-to-treat lymphoma feel better.

  Recruiting at 7 sites Phase 1 Marker Therapeutics, Inc. · Duarte, California and 6 other locations · NCT05798897

• Epcoritamab treatment for patients with follicular lymphoma not responding to initial therapy

  This study is testing if a new treatment called epcoritamab can help people with follicular lymphoma who didn't respond well to their first therapy.

  Recruiting at 3 sites Phase 2 Beth Israel Deaconess Medical Center · Stanford, California and 2 other locations · NCT06510361

• T-Cell Therapy for Adults with Relapsed B-Cell Non-Hodgkin's Lymphoma

  This study is testing a new T-cell therapy to see if it can help adults with relapsed B-cell non-Hodgkin's lymphoma feel better.

  Recruiting at 5 sites Phase 1/2 Estrella Immunopharma, Inc. · Sacramento, California and 4 other locations · NCT06343311

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.