Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin's lymphoma having a history of more than 2 regimens.

Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin's lymphoma having a history of more than 2 regimens. - Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin's lymphoma having a history of more than 2 regimens.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013588

Enrollment

Registered

2014-04-01

Start date

2014-04-01

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

non-Hodgkin&#39

Interventions

Gemcitabine1,000mg/m2(day1,8) Cisplatin 25mg/m2(day1,8) Dexamethasone 8mg/body(day1,2,8,9) Rituximab 8mg/body(day1,8) (CD20 antigen is expressed) to be repeated every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Non-Hodgkin lymphoma. 2. History of treatment more than 2 regimens. 3. Measurable lesion (diameter> 1.5cm). 4. Age 20-79 years. 5. ECOG performance status of 0-1. 6. Adequate organ function. Neutrophil : >=1,500/mm3 Platelet : >= 10,000/mm3 Hb : >= 8.0 mg/dl AST, ALT : >= 100IU mg/L T.bil.: <= 2.0 mg/dl Creatinin : <= 1.2mg/dl (or 24 hr CCr >= 60ml/min) SpO2 : >= 90% 7. Life expectancy of more than 3 month. 8. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Interstitial pneumonitis or pulmonary fibrosis. 2. Prior radiotherapy for the lungs. 3. Uncontrollable diabetes. 4. Uncontrollable heat disease. 5. Uncontrollable infection. 6. History of severe drug allergy. 7. Severe renal disorder. 8. Large quantity of pleural, abdominal or cardiac effusion. 9. Positive for HBs antigen. 10. Positive for HCV antibody. 11. Severe mental disease. 12. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 13. Women who are pregnant or breastfeeding. Men/women who are unwilling to avoid pregnancy. 14. Inadequate for study enrollment by the physician.

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Complete Response Rate Event-Free Survival Progression-Free Survival Safety Completion Rate	—

Countries

Japan

Contacts

Public ContactTsutomu Kobayashi

Kyoto Prefectural University of Medicine Department of Hematology and Oncology,

t-koba@koto.kpu-m.ac.jp075-251-5740

Outcome results

None listed

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

Phase II trial of GDP therapy (gemcitabine, cisplatin and dexamethasone) in patients with refractory or recurrence non-Hodgkin&#39;s lymphoma having a history of more than 2 regimens.