Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT ID: NCT00720109

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-14
• Study Completion Date: 2020-03-31

Brief Summary

This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 dasatinib together with combination chemotherapy may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility and toxicity of an intensified chemotherapeutic regimen that incorporates dasatinib for treatment of children, adolescents, and young adults (up to age 30) with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

II. To determine whether the intensification of tyrosine kinase inhibition through the addition of dasatinib in Induction (Days 15-28) and substitution of dasatinib for imatinib during post-Induction therapy, in the context of intensive cytotoxic therapy (according to AALL0031) and a good early response to therapy, will lead to a 3-year event-free survival (EFS) of at least 60% in patients with Ph+ ALL.

SECONDARY OBJECTIVES:

I. To determine whether the addition of dasatinib during Induction therapy (Days 15-28) will decrease levels of minimal residual disease (MRD) present at end of Induction therapy as compared with COG AALL0031.

II. To determine whether early intensified tyrosine kinase inhibitor (TKI) therapy will lower end-Consolidation MRD levels as compared to patients on COG AALL0031 that received imatinib in Consolidation Blocks 1 and 2 (Cohorts 3-5).

III. To determine the overall 3-year EFS rate for the whole cohort of Standard- and High-Risk patients treated with dasatinib.

IV. To determine the long-term effects of dasatinib on growth, development, and bone metabolism.

V. To assess BCR-ABL mutation status at time of diagnosis and progression/relapse.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (standard risk vs high risk) at the end of consolidation therapy.

INDUCTION THERAPY (weeks 1-4): Patients receive initial induction therapy on days 1-14 prior to beginning the study. Patients then receive vincristine intravenously (IV) and daunorubicin hydrochloride* IV over 15 minutes on days 15 and 22; dasatinib orally (PO) once daily (QD) and prednisone PO (or methylprednisolone IV) twice daily (BID) on days 15-28; methotrexate intrathecally (IT) on day 29; and some patients receive methotrexate, hydrocortisone, and cytarabine IT on days 15 and 22. After completion of induction therapy, patients undergo bone marrow aspiration for evaluation of disease. Patients with M1 bone marrow and minimal residual disease (MRD) < 1% (standard-risk disease) proceed to block 1 consolidation therapy 1 week after completion of induction therapy or when blood counts recover (whichever occurs later). Patients with M2 or M3 bone marrow or MRD >= 1% (high-risk disease) proceed immediately to block 1 consolidation therapy, regardless of blood counts. Patients with clinically evident or biopsy-proven testicular leukemia at diagnosis that persists at the end of induction therapy undergo 12 fractions of testicular radiotherapy beginning within 4 days prior to starting block 1 consolidation therapy.

NOTE: *Patients who receive initial induction therapy on a DFCI Childhood ALL Consortium trial do not receive daunorubicin hydrochloride during induction therapy on this study.

CONSOLIDATION THERAPY:

BLOCK 1 CONSOLIDATION THERAPY: (weeks 6-8) Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5, dasatinib PO on days 1-14 OR on days 1-21, and some patients receive methotrexate, hydrocortisone, and cytarabine IT on days 8 and 15. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV QD beginning on day 6 and continuing until blood counts recover.

After completion of block 1 consolidation therapy, patients proceed to block 2 consolidation therapy.

BLOCK 2 CONSOLIDATION THERAPY: (weeks 9-11) Patients receive high-dose methotrexate IV continuously over 24 hours on day 1; leucovorin calcium PO or IV every 6 hours for 3 doses on days 2-3; methotrexate, hydrocortisone, and cytarabine IT on day 1; cytarabine IV over 3 hours every 12 hours for 4 doses on days 2 and 3; and dasatinib PO on days 1-14 OR on days 1-21. Patients also receive G-CSF SC or IV QD beginning on day 4 and continuing until blood counts recover. After completion of block 2 consolidation therapy and recovery of blood counts, patients undergo bone marrow aspiration for evaluation of disease. Patients with MRD < 0.01% (standard-risk disease) with a matched related donor and who are willing to undergo hematopoietic stem cell transplantation (HSCT) proceed to HSCT off study. Standard-risk patients without a suitable donor or those who elect not to undergo HSCT proceed to post-consolidation therapy. Patients with MRD >= 0.01% (high-risk disease) with a matched related or unrelated donor proceed to HSCT off study. High-risk patients without a suitable donor proceed to post-consolidation therapy.

POST-CONSOLIDATION THERAPY:

REINDUCTION BLOCK 1 THERAPY: (weeks 12-14) Patients receive vincristine IV on days 1, 8, and 15; daunorubicin hydrochloride IV over 15 minutes on days 1 and 2; cyclophosphamide IV over 1 hour every 12 hours for 4 doses on days 3 and 4; pegaspargase intramuscularly (IM) on day 4; methotrexate, hydrocortisone, and cytarabine IT on days 1 and 15; dexamethasone PO or IV BID on days 1-7 and 15-21; and dasatinib PO on days 1-14 OR on days 1-21. Patients also receive G-CSF SC or IV QD beginning on day 5 and continuing until blood counts recover.

After completion of reinduction block 1 therapy, patients proceed to intensification block 1 therapy.

INTENSIFICATION BLOCK 1 THERAPY: (weeks 15-23) Patients receive high-dose methotrexate IV continuously over 24 hours on day 1; leucovorin calcium PO or IV every 6 hours for 3 doses on days 2-3; methotrexate, hydrocortisone, and cytarabine IT on days 1 and 22; etoposide IV over 1 hour and cyclophosphamide IV over 1 hour on days 22-26; cytarabine IV over 3 hours every 12 hours for 4 doses on days 43 and 44; asparaginase IM on day 44; and dasatinib PO on days 1-14, 22-35, and 43-56 OR on days 1-63. Patients also receive G-CSF SC or IV QD beginning on day 27 and continuing until blood counts recover. After completion of intensification block 1 therapy, patients proceed to reinduction block 2 therapy.

REINDUCTION BLOCK 2 THERAPY: (weeks 24-26) Patients receive reinduction block 2 therapy as per reinduction block 1 therapy. After completion of reinduction block 2 therapy, patients proceed to intensification block 2 therapy.

INTENSIFICATION BLOCK 2 THERAPY: (weeks 27-35) Patients receive intensification block 2 therapy as per intensification block 1 therapy. After completion of intensification block 2 therapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY:

MAINTENANCE COURSES 1-4: (weeks 36-67) Patients receive high-dose methotrexate IV continuously over 24 hours on day 1; leucovorin calcium PO or IV every 6 hours for 3 doses on days 2-3; methotrexate, hydrocortisone, and cytarabine IT and vincristine IV on days 1 and 29; prednisone PO or IV BID on days 1-5 and 29-33; mercaptopurine PO on days 8-28; methotrexate PO on days 8, 15, and 22; etoposide IV over 1 hour and cyclophosphamide IV over 1 hour on days 29-33; and dasatinib PO on days 1-14 and 29-42 OR on days 1-56. Patients also receive G-CSF SC or IV QD beginning on day 34 and continuing until blood counts recover. Courses repeat every 56 days. After completion of maintenance courses 1-4, patients proceed to maintenance course 5.

MAINTENANCE COURSE 5: (weeks 68-75) Patients receive vincristine IV on days 1 and 29; prednisone PO or IV BID on maintenance courses 6-12.

MAINTENANCE COURSES 6-12: (weeks 76-131) Patients receive vincristine IV on days 1 and 29; prednisone PO or IV BID on days 1-5 and 29-33; mercaptopurine PO on days 1-56; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, and 50; and dasatinib PO on days 1-14 and 29-42 OR on days 1-56.

Courses repeat every 56 days. Patients long-term growth, development, and bone metabolism are assessed after completion of study therapy and then annually for 5 years.

After completion of study therapy, patients are followed up periodically for up to 10 years.

Conditions

Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzyme inhibitor therapy and chemotherapy)

See Detailed Description

Group Type: EXPERIMENTAL

Asparaginase

Intervention Type: DRUG

Given IT

Cyclophosphamide

Intervention Type: DRUG

Given IV

Cytarabine

Intervention Type: DRUG

Given IT or IV

Dasatinib

Intervention Type: DRUG

Given PO

Daunorubicin Hydrochloride

Intervention Type: DRUG

Given IV

Dexamethasone

Intervention Type: DRUG

Given IV or PO

Etoposide

Intervention Type: DRUG

Given IV

Filgrastim

Intervention Type: BIOLOGICAL

Given IV or SC

Hydrocortisone Sodium Succinate

Intervention Type: DRUG

Given IT

Ifosfamide

Intervention Type: DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Leucovorin Calcium

Intervention Type: DRUG

Given IV or PO

Mercaptopurine

Intervention Type: DRUG

Given PO

Methotrexate

Intervention Type: DRUG

Given IT, PO, or IV

Methylprednisolone

Intervention Type: DRUG

Given IV

Pegaspargase

Intervention Type: DRUG

Given IM

Prednisone

Intervention Type: DRUG

Given PO or IV

Radiation Therapy

Intervention Type: RADIATION

Some patients undergo cranial RT

Vincristine Sulfate

Intervention Type: DRUG

Given IV

Interventions

Asparaginase

Given IT

Intervention Type: DRUG

Cyclophosphamide

Given IV

Intervention Type: DRUG

Cytarabine

Given IT or IV

Intervention Type: DRUG

Dasatinib

Given PO

Intervention Type: DRUG

Daunorubicin Hydrochloride

Given IV

Intervention Type: DRUG

Dexamethasone

Given IV or PO

Intervention Type: DRUG

Etoposide

Given IV

Intervention Type: DRUG

Filgrastim

Given IV or SC

Intervention Type: BIOLOGICAL

Hydrocortisone Sodium Succinate

Given IT

Intervention Type: DRUG

Ifosfamide

Given IV

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Leucovorin Calcium

Given IV or PO

Intervention Type: DRUG

Mercaptopurine

Given PO

Intervention Type: DRUG

Methotrexate

Given IT, PO, or IV

Intervention Type: DRUG

Methylprednisolone

Given IV

Intervention Type: DRUG

Pegaspargase

Given IM

Intervention Type: DRUG

Prednisone

Given PO or IV

Intervention Type: DRUG

Radiation Therapy

Some patients undergo cranial RT

Intervention Type: RADIATION

Vincristine Sulfate

Given IV

Intervention Type: DRUG

Other Intervention Names

ASP-1; Asparaginase II; Asparaginase-E.Coli; Colaspase; Elspar; Kidrolase; L-Asnase; L-ASP; L-asparaginase; L-Asparagine amidohydrolase; Laspar; Lcf-ASP; Leucogen; Leunase; MK-965; Paronal; Re-82-TAD-15; Serasa; Spectrila; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CTX; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamide Monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cyclostine; Cytophosphan; Cytophosphane; Cytoxan; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; .beta.-Cytosine arabinoside; 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone; 1-.beta.-D-Arabinofuranosylcytosine; 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone; 1-Beta-D-arabinofuranosylcytosine; 1.beta.-D-Arabinofuranosylcytosine; 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-; 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-; Alexan; Ara-C; ARA-cell; Arabine; Arabinofuranosylcytosine; Arabinosylcytosine; Aracytidine; Aracytin; Aracytine; Beta-cytosine Arabinoside; CHX-3311; Cytarabinum; Cytarbel; Cytosar; Cytosine Arabinoside; Cytosine-.beta.-arabinoside; Cytosine-beta-arabinoside; Erpalfa; Starasid; Tarabine PFS; U 19920; U-19920; Udicil; WR-28453; BMS-354825; Dasatinib Hydrate; Dasatinib Monohydrate; Sprycel; Cerubidin; Cerubidine; Cloridrato de Daunorubicina; Daunoblastin; Daunoblastina; Daunoblastine; Daunomycin hydrochloride; Daunomycin, hydrochloride; Daunorubicin.HCl; Daunorubicini Hydrochloridum; FI-6339; Ondena; RP-13057; Rubidomycin Hydrochloride; Rubilem; Aacidexam; Adexone; Aknichthol Dexa; Alba-Dex; Alin; Alin Depot; Alin Oftalmico; Amplidermis; Anemul mono; Auricularum; Auxiloson; Baycadron; Baycuten; Baycuten N; Cortidexason; Cortisumman; Decacort; Decadrol; Decadron; Decadron DP; Decalix; Decameth; Decasone R.p.; Dectancyl; Dekacort; Deltafluorene; Deronil; Desamethasone; Desameton; Dexa-Mamallet; Dexa-Rhinosan; Dexa-Scheroson; Dexa-sine; Dexacortal; Dexacortin; Dexafarma; Dexafluorene; Dexalocal; Dexamecortin; Dexameth; Dexamethasone Intensol; Dexamethasonum; Dexamonozon; Dexapos; Dexinoral; Dexone; Dinormon; Fluorodelta; Fortecortin; Gammacorten; Hexadecadrol; Hexadrol; Lokalison-F; Loverine; Methylfluorprednisolone; Millicorten; Mymethasone; Orgadrone; Spersadex; TaperDex; Visumetazone; ZoDex; Demethyl Epipodophyllotoxin Ethylidine Glucoside; EPEG; Lastet; Toposar; Vepesid; VP 16; VP 16-213; VP-16; VP-16-213; VP16; G-CSF; Neupogen; r-metHuG-CSF; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; rG-CSF; Tevagrastim; (11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt; A-Hydrocort; Buccalsone; Corlan; Cortisol sodium succinate; Cortop; Efcortelan; Emergent-EZ; Flebocortid; Hidroc Clora; Hycorace; Hydro-Adreson; Hydrocort; Hydrocortisone 21-Sodium Succinate; Hydrocortisone Na Succinate; Kinogen; Nordicort; Nositrol; Sinsurrene; Sodium hydrocortisone succinate; Solu-Cortef; Solu-Glyc; Asta Z 4942; Asta Z-4942; Cyfos; Holoxan; Holoxane; Ifex; IFO; IFO-Cell; Ifolem; Ifomida; Ifomide; Ifosfamidum; Ifoxan; IFX; Iphosphamid; Iphosphamide; Iso-Endoxan; Isoendoxan; Isophosphamide; Mitoxana; MJF 9325; MJF-9325; Naxamide; Seromida; Tronoxal; Z 4942; Z-4942; Adinepar; Calcifolin; Calcium (6S)-Folinate; Calcium Folinate; Calcium Leucovorin; Calfolex; Calinat; Cehafolin; Citofolin; Citrec; citrovorum factor; Cromatonbic Folinico; Dalisol; Disintox; Divical; Ecofol; Emovis; Factor, Citrovorum; Flynoken A; Folaren; Folaxin; FOLI-cell; Foliben; Folidan; Folidar; Folinac; Folinate Calcium; folinic acid; Folinic Acid Calcium Salt Pentahydrate; Folinoral; Folinvit; Foliplus; Folix; Imo; Lederfolat; Lederfolin; Leucosar; leucovorin; Rescufolin; Rescuvolin; Tonofolin; Wellcovorin; 3H-Purine-6-thiol; 6 MP; 6 Thiohypoxanthine; 6 Thiopurine; 6-Mercaptopurine; 6-Mercaptopurine Monohydrate; 6-MP; 6-Purinethiol; 6-Thiopurine; 6-Thioxopurine; 6H-Purine-6-thione, 1,7-dihydro- (9CI); 7-Mercapto-1,3,4,6-tetrazaindene; Alti-Mercaptopurine; Azathiopurine; BW 57-323H; Flocofil; Ismipur; Leukerin; Leupurin; Mercaleukim; Mercaleukin; Mercaptina; Mercaptopurinum; Mercapurin; Mern; NCI-C04886; Puri-Nethol; Purimethol; Purine, 6-mercapto-; Purine-6-thiol (8CI); Purine-6-thiol, monohydrate; Purinethiol; Purinethol; U-4748; WR-2785; Abitrexate; Alpha-Methopterin; Amethopterin; Brimexate; CL 14377; CL-14377; Emtexate; Emthexat; Emthexate; Farmitrexat; Fauldexato; Folex; Folex PFS; Lantarel; Ledertrexate; Lumexon; Maxtrex; Medsatrexate; Metex; Methoblastin; Methotrexate LPF; Methotrexate Methylaminopterin; Methotrexatum; Metotrexato; Metrotex; Mexate; Mexate-AQ; MTX; Novatrex; Rheumatrex; Texate; Tremetex; Trexeron; Trixilem; WR-19039; Adlone; Caberdelta M; DepMedalone; Depo Moderin; Depo-Nisolone; Duralone; Emmetipi; Esametone; Firmacort; Medlone 21; Medrate; Medrol; Medrol Veriderm; Medrone; Mega-Star; Meprolone; Methylprednisolonum; Metilbetasone Solubile; Metrocort; Metypresol; Metysolon; Predni-M-Tablinen; Prednilen; Radilem; Sieropresol; Solpredone; Summicort; Urbason; Veriderm Medrol; Wyacort; L-Asparaginase with Polyethylene Glycol; Oncaspar; Oncaspar-IV; PEG-asparaginase; PEG-L-Asparaginase; PEG-L-Asparaginase (Enzon - Kyowa Hakko); PEGLA; Polyethylene Glycol L-Asparaginase; Polyethylene Glycol-L-Asparaginase; .delta.1-Cortisone; 1, 2-Dehydrocortisone; Adasone; Cortancyl; Dacortin; DeCortin; Decortisyl; Decorton; Delta 1-Cortisone; Delta-Dome; Deltacortene; Deltacortisone; Deltadehydrocortisone; Deltasone; Deltison; Deltra; Econosone; Lisacort; Meprosona-F; Metacortandracin; Meticorten; Ofisolona; Orasone; Panafcort; Panasol-S; Paracort; Perrigo Prednisone; PRED; Predicor; Predicorten; Prednicen-M; Prednicort; Prednidib; Prednilonga; Predniment; Prednisone Intensol; Prednisonum; Prednitone; Promifen; Rayos; Servisone; SK-Prednisone; Cancer Radiotherapy; Irradiate; Irradiated; irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation; Kyocristine; Leurocristine sulfate; Leurocristine, sulfate; Oncovin; Vincasar; Vincosid; Vincrex; Vincristine, sulfate

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed acute lymphoblastic leukemia (ALL)

• Definitive evidence of BCR-ABL fusion (Philadelphia chromosome positive [PH+]) from an approved Children's Oncology Group (COG) cytogenetics laboratory
• Meets one of the following criteria:

• Concurrent enrollment on Clusters of Orthologous Groups (COG)-AALL03B1 (or a successor trial) AND COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial
• Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND scheduled to receive a 3 or 4-drug standard induction regimen
• Concurrent enrollment on a Dana-Farber Cancer Institute (DFCI) Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
• All patients must have definitive evidence of BCR-ABL fusion from an approved COG cytogenetics laboratory; patients may NOT have received Day 15 of Induction chemotherapy (or day 18 vincristine if enrolled on a DFCI Childhood ALL Consortium trial) prior to enrollment on AALL0622
• Patients must have a performance status of 0, 1 or 2 at completion of two weeks of Induction; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or maximum serum creatinine based on age and gender as follows:

• 0.4 mg/dL (for patients 1 to 5 months of age)
• 0.5 mg/dL (for patients 6 to 11 months of age)
• 0.6 mg/dL (for patients 1 year of age)
• 0.8 mg/dL (for patients 2 to 5 years of age)
• 1.0 mg/dL (for patients 6 to 9 years of age)
• 1.2 mg/dL (for patients 10 to 12 years of age)
• 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
• 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years of age)
• Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN for age
• Shortening fraction >= 27% by echocardiogram or ejection fraction >= 50% by gated radionuclide study
• No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided
• Patients will start AALL0622 therapy on day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial); patients must have received the first 2 weeks of Induction therapy

Exclusion Criteria

• Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
• Female patients who are lactating must agree to stop breast-feeding
• Patients with Down syndrome
• Patients with any clinically significant cardiovascular disease including the following:

• Myocardial infarction or ventricular tachyarrhythmia within 6 months
• Ejection fraction less than institutional normal
• Major conduction abnormality (unless a cardiac pacemaker is present)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William B Slayton

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Hospital of Alabama

Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center

Downey, California, United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Mattel Children's Hospital UCLA

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Valley Children's Hospital

Madera, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

Harbor-University of California at Los Angeles Medical Center

Torrance, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Nemours Children's Clinic - Orlando

Orlando, Florida, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Saint Mary's Hospital

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Michigan State University Clinical Center

East Lansing, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

New York Medical College

Valhalla, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's Hospital

Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Mercy Children's Hospital

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Legacy Emanuel Hospital and Health Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

West Virginia University Charleston Division

Charleston, West Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Royal Children's Hospital-Brisbane

Herston, Queensland, Australia

Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, Australia

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Centre Hospitalier Universitaire de Quebec

Québec, , Canada

Starship Children's Hospital

Grafton, Auckland, New Zealand

Christchurch Hospital

Christchurch, , New Zealand

San Jorge Children's Hospital

San Juan, , Puerto Rico

Countries

United States; Australia; Canada; New Zealand; Puerto Rico

References

Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

Reference Type: DERIVED

PMID: 33242441 (View on PubMed)

Slayton WB, Schultz KR, Kairalla JA, Devidas M, Mi X, Pulsipher MA, Chang BH, Mullighan C, Iacobucci I, Silverman LB, Borowitz MJ, Carroll AJ, Heerema NA, Gastier-Foster JM, Wood BL, Mizrahy SL, Merchant T, Brown VI, Sieger L, Siegel MJ, Raetz EA, Winick NJ, Loh ML, Carroll WL, Hunger SP. Dasatinib Plus Intensive Chemotherapy in Children, Adolescents, and Young Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Results of Children's Oncology Group Trial AALL0622. J Clin Oncol. 2018 Aug 1;36(22):2306-2314. doi: 10.1200/JCO.2017.76.7228. Epub 2018 May 29.

Reference Type: DERIVED

PMID: 29812996 (View on PubMed)

Other Identifiers

NCI-2009-00312

Identifier Type: REGISTRY

Identifier Source: secondary_id

AALL0622

Identifier Type: -

Identifier Source: secondary_id

CDR0000600217

Identifier Type: -

Identifier Source: secondary_id

08-829

Identifier Type: -

Identifier Source: secondary_id

COG-AALL0622

Identifier Type: -

Identifier Source: secondary_id

AALL0622

Identifier Type: OTHER

Identifier Source: secondary_id

AALL0622

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00312

Identifier Type: -

Identifier Source: org_study_id