CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 220 enrolled
Drug / intervention
Rituximab +11 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/NCT00671658
NCT00671658Phase 2Completed
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Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia

M.D. Anderson Cancer Center·interventional·Posted May 5, 2008·Updated Dec 3, 2020

In Brief

A Phase 2 clinical trial evaluating Rituximab, Cyclophosphamide (CTX), and 10 other interventions for Leukemia and Acute Lymphoblastic Leukemia. Completed, enrolled 220 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Lymphoblastic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2008
Enrollment StartNov 1, 2002
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 18.2 years ago

Interventions

Rituximabdrug

375 mg/m2 by vein

Cyclophosphamide (CTX)drug

300 mg/m2 by vein

Doxorubicindrug

50 mg/m2 by vein

Vincristinedrug

2 mg by vein

Dexamethasonedrug

40 mg by vein or by mouth (P.O.)

Methotrexate (MTX)drug

12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8

Cytarabinedrug

100 mg intrathecal for Courses 1,3,5,7 3 gm/m2 by vein for Courses 2,4,6,8

G-CSFdrug

10 ug/kg subcutaneous injection

Mesnadrug

600 mg/m2 a day by vein

Pegylated asparaginasedrug

2000 International units/m2 by vein

Pegfilgrastimdrug

6 mg (flat dose) within 72 hrs after completion of chemotherapy

Solumedroldrug

40 mg by vein for Courses 2,4,6,8