Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.

Trial Health

On Track

Trial Health Score

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

Enrollment

168

participants targeted

Target at P75+ for not_applicable leukemia

Geographic Reach

5 countries

153 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

Study Start

First participant enrolled

November 1, 2004

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed

Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed

8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

August 6, 2015

Completed

Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

8.8 years

First QC Date

November 9, 2004

Results QC Date

July 10, 2015

Last Update Submit

February 14, 2017

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiaB-cell childhood acute lymphoblastic leukemiaT-cell childhood acute lymphoblastic leukemiaTdT positive childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

Event-free Survival
Monitoring of efficacy results will be performed in comparison with historical results.
3 years

Study Arms (2)

CNS Patients-Treatment (combination chemotherapy)

EXPERIMENTAL

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.

Biological: filgrastimDrug: cyclophosphamideDrug: cytarabineDrug: daunorubicin hydrochlorideDrug: dexamethasoneDrug: etoposideDrug: leucovorin calciumDrug: mercaptopurineDrug: methotrexateDrug: pegaspargaseDrug: therapeutic hydrocortisoneDrug: vincristine sulfateRadiation: radiation therapy

Testicular Relapse Patients (Combination chemotherapy)

EXPERIMENTAL

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.