Study of combination of gemcitabine, vinorelbine and dexamethasone chemotherapy in relapsed hodgkins lymphoma

Phase 2

• Conditions: Health Condition 1: null- Adult patients more than 18 years of age with relapsed Hodgkins lymphomaHealth Condition 2: C819- Hodgkin lymphoma, unspecifiedHealth Condition 3: C819- Hodgkin lymphoma, unspecified

• Registration Number: CTRI/2017/04/008361
• Lead Sponsor: Cancer Institute WIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Relapsed/ refractory Hodgkin’s Lymphoma having previously received at least 1 line of standard chemotherapy planned for salvage followed by high dose chemotherapy and autologous stem cell transplantation.

ECOG performance status 0 to 1

Written informed consent must be obtained

Female patients must have a negative

Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable

Exclusion Criteria

CNS involvement by disease

Serious intercurrent illness or medical condition such as active uncontrolled infection or significant cardiac dysfunction that would preclude safe administration of the protocol treatment.

Abnormal Renal function test ( serum creatinine >2mg/dl)

Abnormal liver functions (serum bilirubin >1.5, ALT and AST more than 2.5 fold rise)

Pregnancy in case of female patients

Lack of patient consent

Prior therapy with Gemcitabine or vinorelbine based chemotherapy

Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C infection

Neuropathy >Grade1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)Timepoint: 6 weeks from start of 1 cycle of treatment

Secondary Outcome Measures

Name	Time	Method
•Progression free survival (PFS) <br/ ><br>•Overall survival (OS) <br/ ><br>•Rate of successful stem cell mobilization prior to autologous HSCT <br/ ><br>•Toxicity in terms of Grade 3 or higher adverse events, both hematological and non-hematological <br/ ><br>•No of days of hospitalization per cycle of chemotherapy <br/ ><br>•No days of GCSF use per cycle of chemotherapy <br/ ><br>•Quality of life (QoL) <br/ ><br>Timepoint: •PFS and OS at 1 year and 2 years <br/ ><br>