Clinical trial · Interventional
Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma
NCT00166439CI-TRIAL-00042790completedPhase 2Results 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)
The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside, and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell non-Hodgkins lymphoma (NHL).
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 |
|---|---|---|---|
| Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ROAD)
- description
- The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
- interventionNames
- Drug: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)
Primary outcomes (1)
- measure
- Overall Response Rate After Two Cycles of ROAD
- timeFrame
- Up to 42 days
- description
- The overall response rate is defined as the percentage of patients who achieve a response after two cycles of oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD). A response was considered a Complete Response (CR) or Partial Response (PR) as defined by the NCI Sponsored International Working Group (IWG). CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with any stage (I-IV, including those with bone marrow involvement) relapsed CD20+ B-cell non-Hodgkins lymphoma, within 5 years, with aggressive histology who have not responded to, or relapsed after, initial chemotherapy and would, if treated off-study, be treated with a platinum-containing regimen. * CD20+ diffuse large cell, mantle cell, or transformed histologies are eligible. * Tumor biopsy to demonstrate histology \< = 6 weeks prior to registration. Computed tomography (CT) or ultrasound guided needle biopsies are acceptable as long as the pathologists can confirm histology and the CD20 positivity of the tumor. * Measurable disease (to be considered measurable the lesion must be greater than or equal to 1.5 x 1.5 cm). * Greater than or equal to 18 years of age. * ECOG performance status (PS) 0, 1, or 2. * Limited to one prior chemotherapy regimen. Antibody therapy alone or immunotherapy alone will not count as a prior regimen - only chemotherapy regimens (for example - RCHOP, CVP, etc.). External beam radiation therapy does not count as a regimen. * The following laboratory values obtained less than or equal to 14 days prior to registration: * Absolute neutrophil count (ANC) greater than or equal to 1500 * Platelets (PLT) greater than or equal to 75,000 * Total bilirubin less than or equal to 2 mg/dL * Creatinine less than or equal to 1.5 x upper normal limit (UNL) Exclusion Criteria: * Any of the following as this regimen may be harmful to a developing fetus or nursing child: * Pregnant women * Nursing women * Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) * HIV infection. * Prior chemotherapy or biologic therapy \<= 4 weeks prior to registration . * Persistent acute toxicities due to prior chemotherapy or biologic therapy. * Active malignancies other than NHL. * Central nervous system (CNS) lymphoma. * Any of the following comorbid conditions: * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Uncontrolled peptic ulcer disease * Uncontrolled infection
References
Publications (0)
Data not yet available
No reference posted for this study.