Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma

Conditions

• Classical Hodgkin Lymphoma Relapsed

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• BEGEV (Bendamustine, Gemcitabine,Vinorelbine) — COMBINATION_PRODUCT
  Gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4. Vinorelbine 20 mg/m2 on day 1. Bendamustine 90 mg/m2 on days 2 and 3.
• GDP(Gemcitabine, Dexamethasone and Cisplatin) — COMBINATION_PRODUCT
  Gemcitabine 1000 mg/m2 days 1 and 8. Dexamethasone 20 mg/m2 days 1-4 and days 11-14 Cisplatin 25 mg/m2 days 1-3.

Study Details

The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma. Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year

Key Dates

Start date

Apr 30, 2024

Status verified

Feb 2026

Primary completion

Oct 30, 2024

Completion

Feb 1, 2026

Study Design

Enrollment

88 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine)
  Received the BEGEV protocol
• Active Comparator: GDP arm (Gemcitabine,Dexamethasone,Cisplatin)
  Received the GDP protocol

Primary Outcome Measure

Overall response rate [ Time Frame: Six months ]