Clinical trial · Interventional
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
NCT00075946CI-TRIAL-00073503completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's 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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Rituximab Retreatment
- description
- Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
- interventionNames
- Biological: rituximab
- type
- EXPERIMENTAL
- label
- Arm B: Rituximab Scheduled
- description
- Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
- interventionNames
- Biological: rituximab
Primary outcomes (1)
- measure
- Time to Rituximab Failure (TTRF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA:
* Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:
* Follicular grade 1 or 2
* Small lymphocytic
* Marginal zone (nodal)
* Marginal zone (splenic)
* Mucosa-associated lymphoid tissue (MALT)
* Stage III or IV disease
* Must meet the following criteria for low tumor burden:
* No nodal or extranodal mass at least 7 cm
* Less than 3 nodal masses greater than 3 cm in diameter
* No systemic symptoms or B symptoms
* No splenomegaly greater than 16 cm by a computed tomography (CT) scan
* No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)
* No leukemic phase with greater than 5,000/mm\^3 circulating lymphocytes
* No cytopenias, defined as any of the following:
* Platelet count less than 100,000/mm\^3
* Hemoglobin less than 10 g/dL
* Absolute neutrophil count less than 1,500/mm\^3
* At least 1 objective measurable disease parameter
* Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging
* Age: 18 and over
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Must meet the following criteria for labs:
* Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3\*
* Hemoglobin at least 10 g/dL\*
* Platelet count at least 100,000/mm\^3\*
* NOTE: \*Without growth factor and/or transfusion support
* Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin normal for patients with Gilbert's Syndrome
* The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN
* Hepatitis B surface antigen negative
* Renal
* Creatinine no greater than 2 times ULN
EXCLUSION CRITERIA:
* Evidence of transformation to a large cell histology
* Pregnant or nursing. Fertile patients must use effective contraception
* HIV positive
* Uncontrolled active infection
* Other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Prior immunotherapy for lymphoma
* Prior chemotherapy for lymphoma
* Concurrent chemotherapy
* Prior radiotherapy for lymphoma
* Concurrent radiotherapy
* Concurrent radioimmunotherapyReferences
Publications (3)
- RESULTKahl BS, Williams ME, Hong F, et al.: Preliminary pharmacokinetic (PK) analysis of Eastern Cooperative Oncology Group Protocol E4402: rituximab extended schedule or re-treatment trial (RESORT) . [Abstract] Blood 110 (11): A-3420, 2007.
- RESULTKahl BS, Hong F, Williams ME, Gascoyne RD, Wagner LI, Krauss JC, Habermann TM, Swinnen LJ, Schuster SJ, Peterson CG, Sborov MD, Martin SE, Weiss M, Ehmann WC, Horning SJ. Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: eastern cooperative oncology group protocol e4402. J Clin Oncol. 2014 Oct 1;32(28):3096-102. doi: 10.1200/JCO.2014.56.5853. Epub 2014 Aug 25. PMID 25154829
- DERIVEDRutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5. PMID 35787017