Phase 2
Completed N=50
Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Source: ClinicalTrials.gov NCT00166439 ↗Enrolled (actual)
50
Serious AEs
6.7%
Results posted
Jan 2020
Primary outcomePrimary: Overall Response Rate After Two Cycles of ROAD — 58 percentage of patients
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate After Two Cycles of ROAD |
58 | — |
| SECONDARY Overall Survival |
26 | — |
| SECONDARY Progression-free Survival |
11 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00166439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.