Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma

Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma - Phase II trial of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004205

Enrollment

Registered

2010-09-15

Start date

2010-09-01

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

Malignant lymphoma, non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma

Interventions

Combination therapy of rituximab and cladribine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue and nodal marginal zone B-cell lymphoma 2. CD20-positivity on lymphoma cells by immunohistochemical staining and/or flow cytometry. 3. Clinical stage 3 or 4 by Ann Arbor criteria. 4. At least 1 measurable lesion more than 1.5 cm in at least one dimension by computed tomography, if not any lesions defined by computed tomograghy, magnetic resonance imaging, positron emission tomograghy or endoscopy. 5. No prior chemotherapiy or immunotherapy. 6. Expected to survive for at least 3 months. 7. Performance status (ECOG) of 0 to 2 8. Age 20-79 years 9. No major organ dysfunction (1) Neutrophil counts:more than or equal to 1200/uL (2) Platelet counts:more than or equal to 100000/uL. (3) Hemoglobin more than or equal to 8.0 g/dl (4) Serum bilirubin:less than or equal to 2 x upper limit of normal (In cases with lymphomatous involvement, 5 times and less is allowed.) (5) AST(GOT):less than or equal to 2.5 x upper limit of normal ALT(GPT):less than or equal to 2.5 x upper limit of normal (6) Serum creatinin:less than or equal to 1.5 x upper limit of normal (7) SpO2:more than or equal to 90 percent (8) No abnormalities that require treatment on ECG 10. Patient's written informed consent

Exclusion criteria

Exclusion criteria: (1) Histologically transformed lymphoma. (2) History of glaucoma (3) Peripheral lymphoma cells> 5000/uL (4) Serious bacterial or viral infections. (5) Positive for HBs antigen, HCV antibody or HIV antibody (6) Active cancer or history of malignancies within 5 years, except for carcinoma in situ (7) Interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema. (8) Serious complications (cardiac failure, hepatic failure or renal failure) (9) Psychological complications judged to be difficult to enroll (10) Active disease or history of autoimmune anemia. (11) Serious bleeding tendencies (e.g. disseminated intravascular coagulation) (12) Patients who received granulacyte colony stimulating factor within 2 weeks before registration. (13) Active or suggestive CNS involvement (14) Patients who are pregnant or lactating (15) Inadequate patients to enroll judged by investigators

Design outcomes

Primary

Measure	Time frame
Two-year progression-free survival	—

Secondary

Measure	Time frame
Complete response rate Overall response rate Two-year overall survival rate Time to response Remission duration	—

Countries

Japan

Contacts

Public ContactMichinori Ogura, Tatsuya Suzuki

Nagoya Daini Red Cross Hospital Hematology and Oncology

052-832-1121

Outcome results

None listed

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