CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Regimen A +1 moredrug
Likely dose
Regimen A: Cyclophosphamide 800 mg/m² IV, vincristine 1.5 mg/m² IV, doxorubicin 40 mg/m² IV, high-dose methotrexate 2,700 mg/m² IV, rituximab 500 mg/m² IV (R-CODOX-M); Regimen B: Rituximab 500 mg/m² IV, ifosfamide 1500 mg/m² IV daily, etoposide 60 mg/m² IV daily, cytarabine 2 g/m² IV for 4 doses (R-IFOCE)AI-extracted
Key inclusion· 7
  • ✓Histologically confirmed Burkitt's or Burkitt-like non-Hodgkin's lymphoma
  • ✓Newly diagnosed disease
  • ✓ECOG performance status 0-2
  • ✓Hemoglobin ≥8.0 g/dL, ANC ≥500/mm³, platelets ≥100,000/mm³ (or ≥50,000/mm³ if bone marrow involved)
Key exclusion· 7
  • ✕No New York Heart Association class II-IV heart failure
  • ✕No myocardial infarction within the past 6 months
  • ✕No uncontrolled angina
  • ✕No severe uncontrolled ventricular arrhythmias

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00392990
NCT00392990Phase 2Completed
CompareCT.gov

A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma

Northwestern University·interventional·Posted Oct 26, 2006·Updated Oct 15, 2019

In Brief

A Phase 2 clinical trial evaluating Regimen A and Regimen B for Lymphoma. Completed, enrolled 25 participants across 8 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2006
Enrollment StartFeb 6, 2007
Primary CompletionDec 3, 2011
Study CompletionMay 28, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.7 years ago

Interventions

Regimen Adrug

Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen

Regimen Bdrug

Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)