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

Phase II study of GVDexa (Gemcitabine, Vinorelbine and Dexamethasone) regimen as salvage therapy in relapsed Hodgkins lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008361

Enrollment

Registered

2017-04-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: GVDexa (Gemcitabine, Vinorelbine and Dexamethasone) regimen as salvage therapy in relapsed Hodgkins lymphoma: GVDexa regimen (Q 21 days) Inj Gemcitabine 1000mg/m2 (on Days 1 and 8), In

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR)Timepoint: 6 weeks from start of 1 cycle of treatment	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactRekha Devi

Cancer Institute (WIA)

rekhatrialcoordinator@gmail.com09445021561

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026