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Phase 2 Completed N=50 Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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