GHG-GCD

JRCT ID: jRCT1041230085

Registered date:04/10/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: relapsed or refractory non-Hodgkin's lymphoma
• Date of first enrollment: 05/01/2015
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: complete response rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tsurumi Hisashi