Active, not recruitingNCT04530565Updated Aug 28, 2026

Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

A Phase 3 interventional study of Biospecimen Collection and Blinatumomab in B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by National Cancer Institute (NCI). Active, not recruiting at 211 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 348
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy.

SECONDARY OBJECTIVES:

I. To compare the rate of minimal residual disease (MRD) negative complete remission (CR) for patients treated with chemotherapy versus (vs) blinatumomab at the end of first induction (week 15).

II. To evaluate the rate of the MRD negative CR by treatment arm for those patients MRD positive after the first induction and administered of second induction.

III. To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab.

IV. To assess the toxicities of blinatumomab + TKI vs. TKI + chemotherapy in this patient population.

V. To assess the toxicities of the chemotherapy regimen in this patient population.

VI. To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab + TKI only.

OUTLINE:

ARM A (PRE-INDUCTION): Patients receive prednisone orally (PO) once daily (QD) on days 1-21 and ponatinib hydrochloride (ponatinib) PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.

Patients are randomized to 1 of 2 arms (Arm B or C). Patients undergo bone marrow aspiration with biopsy, lumbar punctures, echocardiogram (ECHO), and multigated acquisition (MUGA) scans as indicated by investigator.

ARM B (INDUCTION THERAPY):

CYCLE 1: Patients receive cyclophosphamide intravenously (IV) twice daily (BID) on days 1-3, dexamethasone PO or IV on days 1-4 and 11-14, cytarabine intrathecally (IT) on day 1, doxorubicin hydrochloride (doxorubicin) IV on day 4, vincristine sulfate (vincristine) IV on days 4 and 11, and methotrexate IT on day 8. Patients also receive Mesna 600mg/m\^2 IV as a 'chemoprotectant' via continuous infusion on days 1-3, (beginning 1 hour prior to cyclophosphamide and completed by 12 hours after the last dose of cyclophosphamide).

CYCLE 2 (AGE 18-70): Starting in cycle 2, fit patients aged 18-70 receive dasatinib 70mg/day PO QD or ponatinib 30mg/day PO QD on days 1-21, methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours BID on days 2-3 of each cycle. On day 22 of cycle 2 or later, as soon as the absolute neutrophil count (ANC) is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul, patients receive hyper cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) for 2 additional cycles.

CYCLE 2 (AGE > 70 or unfit \< 70): Starting in cycle 2, patients age > 70 or younger unfit patients for Hyper-CVAD receive ponatinib PO QD or dasatinib PO QD on days 1-21 of each cycle. Patients also receive methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours BID on days 2-3 of each cycle. Cycle 1 and 2 regimens are each repeated once starting on day 22 of cycle 2, or later, but as soon as the ANC is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul.

Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve remission (significant reduction in the amount of leukemia in bone marrow and blood/MRD negative) after 4 cycles may receive alternative treatment, either consolidation with two cycles of Hyper-CVAD followed by TKI maintenance therapy or undergo allogeneic stem cell transplantation followed by maintenance therapy. Patients who do not achieve a remission (MRD positive) are assigned to Arm D. Patients who experience un-resolving renal failure or life-threatening infection which may require a treatment delay of 21 days cross-over to Arm C to receive the prescribed course of blinatumomab.

ARM C (INDUCTION THERAPY):

CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30.

CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30.

Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

ARM D (RE-INDUCTION): Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C.

ARM E (RE-INDUCTION): Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm.

Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

Patients are followed up every 3 months for first 2 years (from study registration), every 6 months for years 3-5, and then every 12 months for years 6-10.

Conditions studied

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

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
Patient must be >= 18 and =\< 75 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)
- Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation
  - NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
Patient must not have a diagnosis of BCR/ABL T-ALL
Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
Patient must not have unstable epilepsy that requires treatment
Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment
Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 X the institutional upper limit of normal (ULN) (obtained =\< 28 days prior to step 1 registration)
Estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation) (obtained =\< 28 days prior to step 1 registration)
Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met
Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible
Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better
Investigators must confirm which TKI patient is to receive
- NOTE: Patients with known T315I mutation status should receive ponatinib treatment
- NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only
ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2
Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted)
- NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization
Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional upper limit of normal (ULN)
AST(SGOT) and ALT(SGPT) =\< 2 X the institutional upper limit of normal (ULN)
Estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation)
Investigators must confirm which TKI patient is to receive.
- NOTE: Patients with known T315I mutation status should receive ponatinib treatment
For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization
Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated
Patients must have resolved any serious infectious complications related to therapy
Any significant medical complications related to therapy must have resolved
ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION)
Institution has received centralized MRD results confirming positive status
Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional ULN
Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =\< 2 X institutional upper limit of normal (ULN)
Patients who presented with acute organ dysfunction must have an estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation)
Investigators must confirm which TKI patient is to receive
- NOTE: Patients with known T315I mutation status should receive ponatinib treatment
For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined
Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy
Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 348 participants (estimated)

Study arms

Active comparator
Arm A (steroid, TKI), Single Arm Pre-Induction
Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Dasatinib · Procedure: Echocardiography Test · Procedure: Electrocardiography · Procedure: Lumbar Puncture · Procedure: Multigated Acquisition Scan · Drug: Ponatinib Hydrochloride · Drug: Prednisone
Experimental
Arm B (steroid, TKI, chemotherapy)
See Detailed Description.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: Dasatinib · Drug: Dexamethasone · Drug: Doxorubicin Hydrochloride · Procedure: Echocardiography Test · Procedure: Electrocardiography · Procedure: Lumbar Puncture · Drug: Mesna · Drug: Methotrexate · Procedure: Multigated Acquisition Scan · Drug: Ponatinib Hydrochloride · Drug: Vincristine Sulfate
Experimental
Arm C (steroid, TKI, chemotherapy, immunotherapy)
CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30. CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Procedure: Biospecimen Collection · Biological: Blinatumomab · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Dasatinib · Drug: Dexamethasone · Procedure: Echocardiography Test · Procedure: Electrocardiography · Procedure: Lumbar Puncture · Drug: Mesna · Drug: Methotrexate · Procedure: Multigated Acquisition Scan · Drug: Ponatinib Hydrochloride
Experimental
Arm D (steroid, TKI, chemotherapy, immunotherapy)
Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Procedure: Biospecimen Collection · Biological: Blinatumomab · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Cyclophosphamide · Drug: Dasatinib · Drug: Dexamethasone · Procedure: Echocardiography Test · Procedure: Electrocardiography · Procedure: Lumbar Puncture · Drug: Methotrexate · Procedure: Multigated Acquisition Scan · Drug: Ponatinib Hydrochloride
Experimental
Arm E (steroid, TKI, chemotherapy)
Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: Dasatinib · Drug: Dexamethasone · Drug: Doxorubicin Hydrochloride · Procedure: Echocardiography Test · Procedure: Electrocardiography · Procedure: Lumbar Puncture · Drug: Methotrexate · Procedure: Multigated Acquisition Scan · Drug: Ponatinib Hydrochloride · Drug: Vincristine Sulfate

Interventions

ProcedureBiospecimen Collection
Correlative studies
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
BiologicalBlinatumomab
Given IV
Also known as: AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI 538, MEDI-538, MEDI538, MT 103, MT-103, MT103
ProcedureBone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
DrugCyclophosphamide
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, 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, Frindovyx, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719
DrugCytarabine
Given IV or IT
Also known as: .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
DrugDasatinib
Given PO
Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel
DrugDexamethasone
Given PO or IV
Also known as: 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, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
DrugDoxorubicin Hydrochloride
Given IV
Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, FI106, hydroxydaunorubicin, Rubex
ProcedureEchocardiography Test
Undergo ECHO
Also known as: EC, Echocardiography
ProcedureElectrocardiography
Undergo ECG
Also known as: ECG, EKG
ProcedureLumbar Puncture
Undergo lumbar puncture
Also known as: LP, Spinal Tap
DrugMesna
Given IV
Also known as: 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna, Mercaptoethane Sulfonate, Mercaptoethanesulfonate, Mesnex, Mesnil, Mesnum, Mexan, Mistabron, Mistabronco, Mitexan, Mucofluid, Mucolene, UCB 3983, Uromitexan, Ziken
DrugMethotrexate
Given IV or IT
Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, 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
ProcedureMultigated Acquisition Scan
Undergo MUGA
Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, MUGA, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning
DrugPonatinib Hydrochloride
Given PO
Also known as: AP24534 HCl, Iclusig
DrugPrednisone
Given PO
Also known as: .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
DrugVincristine Sulfate
Given IV
Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

What researchers measure

Primary outcomes

Overall survival (OS)
Will compare OS following induction with steroids + tyrosine kinase inhibitor (TKI) + blinatumomab and induction with steroids + TKI + chemotherapy. Will be based on an intent-to-treat analysis. Estimates of OS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of OS between treatment arms will be conducted using the one-sided stratified log-rank test, stratified on the same factors used in the randomization. Cox proportional hazards models of OS, stratified on the same factors used in the randomization, will be used to assess the effect of treatment by adjusting other possible clinical and biological risk factors, including cytogenetic abnormalities.
Time frame: Time between randomization and death from any cause, assessed up to 10 years from the date of registration

Secondary outcomes

Rate of minimal residual disease (MRD) negative complete remission (CR)
Will be centrally evaluated. Will be compared between two arms using Fisher's exact test with a one-sided type I error rate of 2.5%. Multivariable logistic regression modeling will be used to adjust for other possible clinical and biological risk factors. For patients registered to Step 3 (re-induction), the rates of MRD negative CR and their corresponding 95% confidence intervals after re-induction will be given by treatment arm.
Time frame: At the end of first induction (week 15)
Event free survival (EFS)
Will be based on an intent-to-treat analysis. Estimates of EFS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of EFS between treatment arms will be conducted using the one-sided stratified log-rank test, stratified on the same factors used in the randomization. Cox proportional hazards models of EFS, stratified on the same factors used in the randomization, will be used to assess the effect of treatment by adjusting other possible clinical and biological risk factors, including cytogenetic abnormalities
Time frame: Time from randomization to failure to achieve induction molecular remission by the end of first induction, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Rate of MRD negative CR
Will be centrally evaluated. Will be compared between two arms using Fisher's exact test with a one-sided type I error rate of 2.5%. Multivariable logistic regression modeling will be used to adjust for other possible clinical and biological risk factors. For patients registered to Step 3 (re-induction), the rates of MRD negative CR and their corresponding 95% confidence intervals after re-induction will be given by treatment arm.
Time frame: After re-induction
Incidence of adverse events
All toxicity grades and reportable adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 10 years from the date of registration

Study locations

211 sites

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Community Cancer Institute
Clovis, California 93611, United States
University Oncology Associates
Clovis, California 93611, United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
Yale University
New Haven, Connecticut 06520, United States
Augusta University Medical Center
Augusta, Georgia 30912, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813, United States
Queen's Medical Center
Honolulu, Hawaii 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii 96817, United States
Kuakini Medical Center
Honolulu, Hawaii 96817, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii 96701, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii 96701, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii 96701, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301, United States
OSF Saint Anthony's Health Center
Alton, Illinois 62002, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois 60527, United States
Northwestern University
Chicago, Illinois 60611, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois 60491, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045, United States
Loyola University Medical Center
Maywood, Illinois 60153, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois 60160, United States
SSM Health Good Samaritan
Mount Vernon, Illinois 62864, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202, United States
Mary Greeley Medical Center
Ames, Iowa 50010, United States
McFarland Clinic - Ames
Ames, Iowa 50010, United States
McFarland Clinic - Boone
Boone, Iowa 50036, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158, United States
Central Care Cancer Center - Garden City
Garden City, Kansas 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530, United States
University of Kansas Cancer Center
Kansas City, Kansas 66160, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan 48114, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan 48188, United States
Chelsea Hospital
Chelsea, Michigan 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Henry Ford Hospital
Detroit, Michigan 48202, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334, United States
Cancer Hematology Centers - Flint
Flint, Michigan 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503, United States
Hurley Medical Center
Flint, Michigan 48503, United States
Allegiance Health
Jackson, Michigan 49201, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan 48044, United States
Henry Ford Medical Center-Columbus
Novi, Michigan 48377, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604, United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan 48315, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan 48764, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322, United States

Showing the first 100 of 211 sites across 3 countries.

References and documents

Publications

Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PubMed 41671463 ↗

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04530565
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Aug 28, 2020
Start date: Jan 25, 2021
Primary completion: Jul 1, 2028 (estimated)
Completion: Jul 1, 2028 (estimated)
Last update: Aug 28, 2026

Study contacts

Yishai Ofran

principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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