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| ID | Type | Description | Link |
|---|---|---|---|
| PEDSHEMALL0015 | Other Identifier | Stanford OnCore | |
| NCI-2023-04129 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| The Pediatric Oncology Experimental Therapeutics Investigators' Consortium | OTHER |
| Amgen | INDUSTRY |
| Lucile Packard Foundation for Children's Health | UNKNOWN |
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The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given orally (PO) or naso-gastrically (NG) or intravenously (IV). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease | Proportion of patients who are minimal residual disease positive at the end of Induction Intensification | 5 years and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy | To determine the estimated minimum safe and biologically-effective dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs, MRD assessments, and pharmacokinetic studies | 5 years and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanja A Gruber, MD, PhD | Contact | 650 723 5535 | tagruber@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tanja A Gruber, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41671463 | Derived | 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. |
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| Kura Oncology, Inc. |
| INDUSTRY |
| United States Department of Defense | FED |
| Cannonball Kid's Cancer | UNKNOWN |
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| Mitoxantrone |
| Drug |
Given IV |
|
| PEG asparaginase | Drug | Given IV |
|
| Bortezomib | Drug | Given IV |
|
| Vorinostat | Drug | Taken PO or NG |
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| Mercaptopurine | Drug | Given PO or NG. |
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| Methotrexate | Drug | Given IV, IM or PO |
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| Blinatumomab | Drug | Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction |
|
| Ziftomenib | Drug | 3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D |
|
| Event Free Survival |
To estimate the 3-year event-free survival for subjects treated on study |
| 8 years |
| Overall Survival | To estimate the 3-year overall survival for subjects treated on study | 8 years |
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
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| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| Valley Children's Hospital | Recruiting | Madera | California | 93636 | United States |
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| Children's Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
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| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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| Rady Children's Hospital San Diego | Not yet recruiting | San Diego | California | 92123 | United States |
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| Arnold Palmer Hospital for Children | Recruiting | Orlando | Florida | 32806 | United States |
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| Children's Hospital of Minnesota | Recruiting | Minneapolis | Minnesota | 55404 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Novant Health - Hemby Children's Hospital | Not yet recruiting | Charlotte | North Carolina | 28204 | United States |
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| Doernbecher Children's Hospital | Recruiting | Portland | Oregon | 97239 | United States |
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| Penn State Milton S Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033-0850 | United States |
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| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| University of Texas Health Science Center San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| University of Utah Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| Children's Hospital of The King's Daughters | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Alberta Children's Hospital | Not yet recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| Stollery Children's Hospital | Not yet recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| BC Children's Hospital | Not yet recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
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| McMaster Children's Hospital | Not yet recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
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| CHU Sainte-Justine | Not yet recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| Montreal Children's Hospital | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Chu De Quebec | Not yet recruiting | Québec | Quebec | G1V 4G2 | Canada |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008942 | Mitoxantrone |
| C042705 | pegaspargase |
| D000069286 | Bortezomib |
| D000077337 | Vorinostat |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| C510808 | blinatumomab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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