ALL Backbone in AYAs

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 51 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• 1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.
• Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.
• o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.
• Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:
• Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).
• IT chemotherapy.
• Emergent radiation therapy or leukapheresis for life threatening complications.
• One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction).
• 1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin <1.4 mg/dL (total bilirubin < 1.4 mg/dL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.
• 1.6 Ability to understand and the willingness to sign a written informed consent document.

You cannot join if

• Philadelphia chromosome-positive / BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. [FISH/PCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.
• 2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.
• 2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

autologous blinatumomab-expanded T cells. A preparation of autologous, peripheral blood-derived polyclonal activated T cells that have been expanded and activated ex-vivo using blinatumomab and recombinant human IL2 (rhIL-2) and depleted of contaminating CD19+ tumor cells, with potential immunomodulating activity. Upon administration, these blinatumomab-expanded T cells (BET), composed of functional polyclonal CD4+ and CD8+ T cells and mostly effector and central memory cells, may induce immunological recovery. BET cell expansion leads to the lysis and elimination of contaminating CD19+ tumor cells. The elimination of contaminating tumor cells is important in the treatment of non-Hodgkin CD20 + indolent lymphoma (iNHL) and chronic lymphatic leukemia (CLL). NCI Drug Dictionary

Treatments listed in the registry

• Blinatumomab (Drug): A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
• Oncaspar (Drug): A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
• Cyclophosphamide (Drug): An alkylating agent, single-use vial via intravenous infusion, per standard of care
• Cytarabine (Drug): An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
• Dexamethasone (Drug): A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
• Doxorubicin Hydrochloride (Drug): An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
• Etoposide (Drug): A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
• Mercaptopurine (Drug): A purine antagonist, tablet via orally, per standard of care
• Methotrexate (Drug): A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
• Vincristine (Drug): A vinca alkaloid, single-use vials via intravenous injection, per standard of care

Non Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• bone marrow: Part of the study plan
• echocardiogram: Part of the study plan
• ECG: Part of the study plan

Main goals

• Treatment Completion Rate Through Time Point 3 (TP3) (Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum)

Other goals

• Rate of Treatment-Related Mortality (TRM)
• Rate of Treatment Discontinuation due to Toxicity or Disease
• Rate of Asparaginase Non-Completion
• Reason of Asparaginase Non-Completion
• Grade 3 Infections Toxicity Rate
• Grade 3 Asparaginase-associated Toxicities Rate
• Grade 3 Orthopedic Toxicity Rate
• Complete remission Rate (CRR)
• Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IA (Time Point 1)
• Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IB (Time Point 2)
• Measurable Residual Disease (MRD) Negativity Rate at Time Point 3 (TP3)
• Median Event-Free Survival (EFS)
• Median Disease-Free Survival (DFS)
• Median Overall Survival (OS)
• Rate of Allogeneic Transplantation
• Reason of Allogeneic Transplantation

Planned enrollment: 67 (estimated).

• Dana Farber Cancer Institute, Boston, Massachusetts

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07227584
• NCI Drug Dictionary: C62528

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 16, 2026. Public record; not medical advice.