CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Filgrastim +8 morebiological
Likely dose
R-CVP: Rituximab 375 mg/m² (Days 1, 8), Cyclophosphamide 1500 mg/m² (Day 1), Vincristine 1.4 mg/m² (Day 1), Prednisone 100 mg (Days 1-5) per cycle; plus high-dose cyclophosphamide 50 mg/kg/day (Days -3 to 0) and rituximab 375 mg/m² with weekly dosing × 4 weeks post-HiCyAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed classic, sporadic Burkitt lymphoma; Burkitt leukemia (FAB L3); or atypical Burkitt/Burkitt-like lymphoma with characteristic morphology, high proliferative index, and Ki-67 ≥85%
  • ✓Age 30 years or older
  • ✓Newly diagnosed or untreated disease (prior steroids allowed)
  • ✓No known irreversible renal dysfunction precluding high-dose cyclophosphamide
Key exclusion· 5
  • ✕Prior chemotherapy for lymphoma (maximum 2 prior intrathecal chemotherapy doses allowed)
  • ✕Prior radiation therapy for lymphoma
  • ✕Known HIV positivity
  • ✕Other malignancy within past 3 years, except basal cell/squamous cell skin cancer or cervical carcinoma in situ

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

Search/NCT00133991
NCT00133991Phase 2Completed
CompareCT.gov

Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Aug 24, 2005·Updated Sep 17, 2018

In Brief

A Phase 2 clinical trial evaluating Filgrastim, Rituximab, and 7 other interventions for Leukemia and Lymphoma. Completed, enrolled 23 participants across 2 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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 combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2005
Enrollment StartJul 1, 2005
Primary CompletionAug 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.9 years ago

Interventions

Filgrastimbiological

5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.

Rituximabbiological

375 mg/m\^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m\^2 on Day -4 of HiCy and weekly for four weeks after HiCy.

Cyclophosphamidedrug

1500 mg/m\^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.

Cytarabinedrug

100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

Methotrexatedrug

3 g/m\^2 on Day 8 of each cycle of R-CVP.

Prednisonedrug

100 mg on Days 1-5 of each cycle of R-CVP.

Hydrocortisonedrug

50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

Vincristinedrug

1.4 mg/m\^2 on Day 1 of each cycle of R-CVP.

Leucovorindrug

25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.