A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma.

A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma. - A phase II study of Cladribine and Rituximab therapy for relapsed indolent B-cell Non-Hodgkin's Lymphoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001570

Enrollment

Registered

2008-12-18

Start date

2004-11-01

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

low grade B cell lymphoma

Interventions

Cladribine 0.09mg/kg (day1-5) combined with Rituximab 375mg/m2 (day 1 and 15) is administrated every 4 weeks (total 4 cycles).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.pathological diagnosis: low grade B cell lymphoma. 2.CD20 antigen positive. 3.presence of mesurable lesions. 4.relapsed case after previous systemic chemotherapies. 5.washout duration from previous chemotherapy: more than 4 weeks after systemic chemoterapy and more than 3 months after rituximab treatment. 6.at least 3 months of life expectancy. 7.PS(ECOG): 0-2. 8.adequate organ function. 9.informed consented patients for this clinical trial.

Exclusion criteria

Exclusion criteria: 1.previous exposures of cladribine, fludarabine, or pentostatin. 2.treatment histories of more than one allogenic stem cell transplantasion or more than 2 times of autologous stem cell transplantation. 3.transformed case at registration. 4.past history of glaucoma. 5.presence of active infection. 6.HBs Ag posivtive, HCV Ab positive, HIV Ab positive. 7.presence of lymphoma cells more than 5000/mm3 in periperal blood. 8.past history of severe drug allergy. 9.presence of other active malignancy. 10.diabetis melitus recieving insulin therapy. 11.severe mental disorder. 12.autoimmune hemolytic anemia. 13.severe bleeding tendency. 14.recieving CSF or blood transfusion within 2 weeks of registration. 15.presence of central nervous involvement (clinical or pathological). 16.pregnant or feeding female. 17.recieving unapproved anti cancer agents within 3 months of registration. 18.judged for inappropriate by other reasons.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
complete response rate, 2 years progression free survival, 2 years overall survival, time to best response, duration of remission, safety	—

Countries

Japan

Contacts

Public ContactHIROKAZU NAGAI

National Hospital Organization Nagoya Medical Center Clinical Research Center

nagaih@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

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

A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin&#39;s Lymphoma.