CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
filgrastim +16 morebiological
Likely dose
Multi-drug regimen: Daunorubicin 60 mg/m² IV days 1-3, Vincristine 1.4 mg/m² (max 2 mg) IV days 1,8,15,22, Asparaginase 2,000 IU/m² IM/IV day 15, Prednisone 60 mg/m² PO/IV days 1-35, followed by Induction 2 with Cytarabine 3 g/m² IV days 1-5, Mitoxantrone 80 mg/m² IV day 3, Dexamethasone 0.1% QID eye drops days 1-6, followed by consolidation and post-consolidation courses with cyclophosphamide, cytarabine, doxorubicin, mercaptopurine, methotrexate, and maintenance for 2 yearsAI-extracted
Key inclusion· 9
  • ✓Morphologically confirmed acute lymphoblastic leukemia (ALL), FAB class L1 or L2 disease, or mixed lineage ALL
  • ✓Ph-negative/BCR-ABL negative disease
  • ✓Newly diagnosed disease
  • ✓Age 18 to 64 years
Key exclusion· 8
  • ✕FAB class L3 ALL
  • ✕Non-Hodgkin's lymphoma
  • ✕Chronic myelogenous leukemia in lymphoid blast crisis
  • ✕Mixed lineage acute myeloid leukemia or acute minimally differentiated myeloid leukemia (M0)

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

Search/NCT00109837
NCT00109837Phase 2Completed
CompareCT.gov

A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy

SWOG Cancer Research Network·interventional·Posted May 4, 2005·Updated Mar 25, 2015

In Brief

A Phase 2 clinical trial evaluating filgrastim, cyclophosphamide, and 15 other interventions for Leukemia. Completed, enrolled 79 participants across 78 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), and giving the drugs in different combinations may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2005
Enrollment StartApr 1, 2005
Primary CompletionNov 1, 2010
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 21.2 years ago

Interventions

filgrastimbiological

As needed per physician discretion

cyclophosphamidedrug

Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

cytarabinedrug

Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

daunorubicindrug

Induction: 60 mg/m2/d; IV; days 1, 2, and 3

dexamethasonedrug

Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

doxorubicindrug

Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

leucovorindrug

For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC \< 3,000

mercaptopurinedrug

Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

methotrexatedrug

Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

mitoxantronedrug

Induction 2: 80 mg/m2; IV; day 3

Asparaginasedrug

Induction: 2,000 IU/m2; IM or IV; day 15

prednisonedrug

Induction: 60 mg/m2/d; PO or IV; days 1-35

thioguaninedrug

Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

vincristinedrug

Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

radiation therapyradiation

For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

allopurinoldrug

300 mg/d PO Days 1-7

bactrimdrug

1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone