CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Cyclophosphamide (CTX) +7 moredrug
Likely dose
Cyclophosphamide (CTX) 300 mgfrom 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/NCT00890656
NCT00890656Phase 2Completed

Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

M.D. Anderson Cancer Center·interventional·Posted Apr 30, 2009·Updated Feb 20, 2012

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide (CTX), Vincristine, and 6 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this therapy will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 30, 2009
Enrollment StartJun 1, 2003
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 17.2 years ago

Interventions

Cyclophosphamide (CTX)drug

300 mg/m\^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of

Vincristinedrug

2 mg by vein (IV) weekly for 3: Days 1, 8, 15

Doxorubicindrug

50 mg/m\^2 by vein (IV) over 24 hours

Decadrondrug

80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18

G-CSFdrug

10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours

Methotrexate (MTX)drug

200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1

Ara-Cdrug

3 gm/m\^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.

Pegaspargasedrug

2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses