First line chemotherapy for Hodgkin Lymphoma in Russia
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
This study is testing different chemotherapy treatments for adults with Hodgkin Lymphoma in Russia to see which one helps them live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, doxorubicin |
| Locations | 2 sites (Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012 and 1 other locations) |
| Trial ID | NCT04638790 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with histologically confirmed classical Hodgkin Lymphoma who have not received prior treatment.
Not a fit: Patients with relapsed or refractory Hodgkin Lymphoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored chemotherapy regimens for patients with Hodgkin Lymphoma, improving their chances of long-term remission.
How similar studies have performed: Other studies have shown success with similar chemotherapy approaches for Hodgkin Lymphoma, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012 and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.