Clinical trial · Interventional
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine Phosphate (Fludara) | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Fludarabine Phosphate (Fludara)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- The best response until the end of 6th treatment cycle
Secondary outcomes (3)
- measure
- CR rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.) * Patients with measurable lesions (\> 1.5 cm). * Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies). * ECOG performance status: 0 - 1 * Patients with adequately maintained organ functions. Exclusion Criteria: * Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever \</=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma. * Patients who are positive for HBs antigen, HCV antibody, or HIV antibody. * Patients who received G-CSF or transfusion within 1 week before the registration. * Patients with the history of allergies to purine nucleoside analogue. * Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products. * Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy). * Patients who had progressive disease within 6 months of receiving therapy including rituximab. * Women who are pregnant, of childbearing potential, or lactating. * Patients who do not agree to practice contraception.
References
Publications (1)
- DERIVEDTobinai K, Ishizawa K, Ogura M, Itoh K, Morishima Y, Ando K, Taniwaki M, Watanabe T, Yamamoto J, Uchida T, Nakata M, Terauchi T, Nawano S, Matsusako M, Hayashi M, Hotta T. Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma. Cancer Sci. 2009 Oct;100(10):1951-6. doi: 10.1111/j.1349-7006.2009.01247.x. Epub 2009 Jun 17. PMID 19594547