CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,949 enrolled / 5,949 target
Drug / intervention
Clofarabine +17 moredrug
Likely dose
Not stated in 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/NCT02883049
NCT02883049Phase 3CompletedMonitor (34.6/mo)Completion was 42mo ago
CompareCT.gov

A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

National Cancer Institute (NCI)·interventional·Posted Aug 30, 2016·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Clofarabine, Cyclophosphamide, and 16 other interventions for B Acute Lymphoblastic Leukemia and 3 related conditions. Completed, enrolled 5,949 participants across 239 sites in 7 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia, Testicular Leukemia
CountriesAustralia, Canada, Ireland, New Zealand, Puerto Rico, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2016
Enrollment StartFeb 29, 2012
Primary CompletionDec 31, 2022
Study CompletionMar 31, 2026
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 9.8 years ago

Arms & Interventions

DS HR B-ALL (RER)experimental

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: DexamethasoneDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: ThioguanineDrug: Vincristine Sulfate
DS HR B-ALL (SER)experimental

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: ThioguanineDrug: Vincristine Sulfate
Group I Arm A (HR B-ALL)experimental

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: ThioguanineDrug: Vincristine Sulfate
Group I Arm B (HR B-ALL) (CLOSED 03/19/2018)experimental

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideDrug: Hydrocortisone Sodium SuccinateOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: ThioguanineDrug: Vincristine Sulfate
Group II Arm A (VHR B-ALL - Control Arm)active_comparator

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: ThioguanineDrug: Vincristine Sulfate
Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)experimental

Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: Doxorubicin HydrochlorideDrug: EtoposideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: Vincristine Sulfate
Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014)experimental

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Drug: ClofarabineDrug: CyclophosphamideDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideDrug: EtoposideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneRadiation: Radiation TherapyDrug: Vincristine Sulfate
Group III PH-like predicted TKI-sensitive kinase mutationexperimental

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Drug: CyclophosphamideDrug: CytarabineDrug: DasatinibDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MercaptopurineDrug: MethotrexateDrug: PegaspargaseDrug: PrednisoneDrug: Vincristine Sulfate

Interventions

Clofarabinedrug

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT, IV, or SC

Dasatinibdrug

Given PO

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

PO or IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Hydrocortisone Sodium Succinatedrug

Given IT

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given PO or IV

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT and IV

Pegaspargasedrug

Given IV

Prednisonedrug

Given PO or IV

Radiation Therapyradiation

Undergo radiation therapy

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV