NCT00866918|CompletedPhase 3Results

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation

Children's Oncology Group ClinicalTrials.gov

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4 other identifiers

AAML0631NCI-2011-01904CDR0000637184U10CA098543

Study Type

interventional

Target

106

Locations

3 countries

Sites

121

Timeline

RegisteredMar 2009

StartedMar 2009

CompletionSep 2022

Brief Summary

This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. 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) may kill more cancer cells.

Trial Health

On Track

Trial Health Score

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

Enrollment

106

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach

3 countries

121 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.6 years study duration

Study Start

First participant enrolled

March 9, 2009

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed

Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

6.3 years

First QC Date

March 20, 2009

Results QC Date

October 25, 2016

Last Update Submit

October 3, 2022

Conditions

Childhood Acute Promyelocytic Leukemia With PML-RARA Myeloid Neoplasm

Outcome Measures

Primary Outcomes (1)

Event-free Survival (EFS)
EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.
At 3 years from study entry

Secondary Outcomes (3)

Hematologic Remission Rate
End of consolidation, course 1: up to 5 months
Hematologic, Molecular, and Cytogenetic Remission Rate
End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)
Overall Survival (OS)
At 3 years from study entry

Study Arms (2)

Arm I (standard risk, combination chemotherapy)

EXPERIMENTAL

See Detailed Description

Drug: Arsenic TrioxideDrug: CytarabineOther: Diagnostic Laboratory Biomarker AnalysisDrug: IdarubicinDrug: MercaptopurineDrug: MethotrexateDrug: Mitoxantrone HydrochlorideDrug: Tretinoin

Arm II (high risk, combination chemotherapy)

EXPERIMENTAL

See Detailed Description.

Drug: Arsenic TrioxideDrug: CytarabineOther: Diagnostic Laboratory Biomarker AnalysisDrug: IdarubicinDrug: MercaptopurineDrug: MethotrexateDrug: Mitoxantrone HydrochlorideDrug: Tretinoin

Interventions

Arsenic TrioxideDRUG

Given IV

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride, Arsenous Oxide, ATO, Trisenox, White Arsenic