Recruiting
Phase 3
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
Condition(s) studied
Hodgkin Lymphoma, Adult
Investigational drug(s) / intervention(s)
DoxorubicinBleomycinVinblastineDacarbazineEtoposideDoxorubicinCyclophosphamideVincristineDexamethasoneDacarbazine
Doxorubicin: 25 mg/m2 i.v. day 1,15 for ABVD/AVD
Bleomycin: 10,000 units/m2 i.v. days 1,15 for ABVD
Vinblastine: 6 mg/m2 i.v. days 1,15 for ABVD/AVD
Dacarbazine: 375 mg/m2 i.v. days 1,15 for ABVD/AVD
Etoposide: 100 mg/m2 i.v. days 1-3
Doxorubicin: 50 mg/m2 i.v. day 1 for EACODD-14
Cyclophosphamide: 650 mg/m2 i.v. day 1
Vincristine: 1,4 mg/m2 i.v. day 8
Dexamethasone: 20 mg i.v. days 1-3
Dacarbazine: 375 mg/m2 i.v. day 1 for EACODD-14
Study summary
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).
Eligibility
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.
Primary outcome measure(s)
- Complete remission rate (CR) — up to 6 months
CR rate is defined as the proportion of patients achieving a CR after 3 months of chemotherapy (interim) and at the end of treatment
- Acute Toxicity — 6 months
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
- Late Toxicity — 5 years
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
- Event-Free Survival (EFS) — 5 years
EFS will be measured from the time from entry onto a study to any treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment lacking documented progression, or death)
- Disease free survival (DFS) — 5 years
DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Tata Memorial Hospital |
Mumbai |
Opd-81 Main Building, Dr. E Borges Road, Parel 400012 |
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 |