Clinical trial · Interventional
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
NCT04638790CI-TRIAL-00081110HL-Russia-1recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma, Adult | Adult Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Early favorable HL
- description
- HL without adverse prognostic factors
- interventionNames
- Drug: Doxorubicin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: Dacarbazine
- type
- EXPERIMENTAL
- label
- Early unfavorable HL
- description
- Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, age less than 50 years)
- interventionNames
- Drug: Doxorubicin
- Drug: Vinblastine
- Drug: Dacarbazine
- Drug: Etoposide
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Dexamethasone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.