NCT00003700|CompletedPhase 2

Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-19802U10CA031946CDR0000066807

Study Type

interventional

Target

163

Locations

1 country

Sites

Timeline

RegisteredMay 2004

StartedJan 1999

CompletionJan 2010

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

163

participants targeted

Target at P75+ for phase_2 leukemia

Timeline

Completed

Started Jan 1999

Longer than P75 for phase_2 leukemia

Geographic Reach

1 country

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 years study duration

Study Start

First participant enrolled

January 1, 1999

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed

4 months until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed

5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

5.1 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2016

Conditions

Leukemia

Keywords

untreated adult acute lymphoblastic leukemiaL1 adult acute lymphoblastic leukemiaL2 adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

Complete Response
6 months post treatment

Secondary Outcomes (2)

Toxicity
prior to ea tx and ea maintenance course
CNS relapse rate
before ea tx, q 3 mon for 1 yr, q 6 mon for 2 yrs, then yrly up to 10 yrs

Study Arms (1)

Daunorubicin, ara-C, & MTX Therapy

EXPERIMENTAL

daunorubicin during induction, increasing doses of cytarabine during consolidation followed by methotrexate in place of cranial irradiation for treatment of ALL

Biological: G-CSFDrug: asparaginaseDrug: cyclophosphamideDrug: cytarabineDrug: daunorubicin hydrochlorideDrug: leucovorin calciumDrug: mercaptopurineDrug: methotrexateDrug: prednisoneDrug: vincristine sulfateDrug: Allopurinol

Interventions

G-CSFBIOLOGICAL

Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC \> 5,000 uL after nadir: 7 day minimum for Courses I \& IV

Also known as: filgrastim