Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma

Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma - GHG-GCD

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015998

Enrollment

Registered

2014-12-19

Start date

2014-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

relapsed or refractory non-Hodgkin&#39

Interventions

GCD +/- R therapy Gemcitabine 1000mg/sqm Day 1,8 Carboplatin AUC5 Day 1 Dexamethasone 40mg Day 1-4 *if CD 20 is positive Rituximab 375mg/sqm Day 8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients have pathologically confirmed refractory or relapsed non-Hodgkin lymphoma. 2) Patients had received prior treatment of rituximab in combination with CHOP or THP-COP. 3) Patients aged >= 18 years. 4) ECOG performance status of 0-2 5) Patients have measurable lesion. 6) Patients without interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT. 7) Patients have a life expectancy > 12 weeks. 8) Written informed consent. 9) Patients meet all following standard. Absolute neutrophil count >= 1,000/mm3 Hemoglobin >= 8.0 g/dL Platelet count >= 75,000/mm3 AST and ALT < 2.5 times facility criteria. Total bilirubin < 2.5 times facility criteria.

Exclusion criteria

Exclusion criteria: 1) Patients have CNS invasion. 2) HIV antibody positive. 3) Patients have interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT. 4) Patients undergoing chest radiotherapy. 5) Patients have major heart/lung disorders, or uncontrolled diabetes mellitus. 6) Patients are pregnant or lactating women. Patients cannot or will not use birth control during the treatment. 7) Patients have active other malignant diseases. 8) Patients have severe allergic symptoms. 9) Patients have chemotherapy resistant lymphoma. 10) Inadequate for clinical trial entry by the attending physicians.

Design outcomes

Primary

Measure	Time frame
complete response rate	—

Secondary

Measure	Time frame
overall response rate overall survival progression free survival safety peripheral blood stem cell harvest (transplant case)	—

Countries

Japan

Contacts

Public ContactJunichi Kitagawa

Gifu University Hospital First Department of Internal Medicine

jkitagawa1128@gmail.com058-230-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin&#39;s lymphoma