CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Rituximab +7 moredrug
Likely dose
Rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00669877
NCT00669877Phase 2Completed

Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma

M.D. Anderson Cancer Center·interventional·Posted May 1, 2008·Updated May 16, 2018

In Brief

A Phase 2 clinical trial evaluating Rituximab, Cyclophosphamide, and 6 other interventions for Burkitt's Lymphoma and Burkitt'S-like Lymphoma. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. The safety of the combined treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 1, 2008
Enrollment StartAug 1, 2002
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 13.2 yearsPosted 18.2 years ago

Interventions

Rituximabdrug

375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses.

Cyclophosphamidedrug

300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses).

Doxorubicindrug

50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).

Vincristinedrug

2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses)

Dexamethasonedrug

40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses)

G-CSFdrug

10 mcg/kg

Cytarabinedrug

100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).

Methotrexatedrug

200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.