Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
67 participants
INTERVENTIONAL
2026-04-30
2035-07-31
Brief Summary
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The names of the study drugs involved in this study are:
* blinatumomab (a type of immunotherapy drug)
* cyclophosphamide (a type of chemotherapy drug)
* cytarabine (a type of antineoplastic agent)
* dexamethasone (a type of synthetic glucocorticoid)
* doxorubicin (a type of antineoplastic agent)
* etoposide (a type of antineoplastic agent)
* mercaptopurine (a type of antineoplastic agent)
* methotrexate (a type of chemotherapy drug)
* pegaspargase (a type of antineoplastic agent)
* vincristine (a type of antineoplastic agent)
Detailed Description
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The U.S. Food and Drug Administration (FDA) has approved all of the drugs of treatment being studied but the investigators of this research study want to understand more about the safety and effectiveness of the chemotherapy regimen in adolescents and young adults with newly diagnosed Philadelphia chromosome-negative ALL.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, saliva tests, X-rays, electrocardiograms (ECGs), echocardiograms (ECHOs), Dual-Energy X-ray Absorptiometry (DEXA) scans, bone marrow aspirations/biopsies.
Participation in this study is expected to last about 10 years, 2 years of treatment followed by 8 years of follow up.
It is expected that about 67 people will take part in this research study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALL Backbone Regimen for B-Cell
* Steroid Prophase (3-dy cycle): Dexamethasone \& cytarabine
* Induction IA (29-dy cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy
* Induction IB (42-dy cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy
* Blinatumomab Cycle 1, 2 (42-dy cycles): Blinatumomab, dexamethasone, IT chemotherapy
* Consolidation I:
* Phase IA (28-dy cycle), Phase IC (21-dy cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy
* Blinatumomab Cycle 3 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy
* Consolidation II (21-dy cycles for 30 wks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy
* Blinatumomab Cycle 4 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy
* Continuation (21-dy cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy
* End of treatment visit
* Follow up
Blinatumomab
A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
Oncaspar
A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
Cyclophosphamide
An alkylating agent, single-use vial via intravenous infusion, per standard of care
Cytarabine
An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
Dexamethasone
A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
Doxorubicin Hydrochloride
An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
Etoposide
A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
Mercaptopurine
A purine antagonist, tablet via orally, per standard of care
Methotrexate
A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
ALL Backbone Regimen for T-Cell
* Steroid Prophase (3-day cycle): Dexamethasone and cytarabine
* Induction IA (29-day cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy
* Induction IB (42-day cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy
* Consolidation I:
* Phase IA (28-day cycle) and Phase IC (21-day cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy
* CNS Phase (21-day cycle): Dexamethasone, vincristine, mercaptopurine, pegaspargase, IT chemotherapy
* Consolidation II (21-day cycles for 30 weeks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy
* Continuation (21-day cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy
* End of treatment visit
* Follow up
Blinatumomab
A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
Oncaspar
A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
Cyclophosphamide
An alkylating agent, single-use vial via intravenous infusion, per standard of care
Cytarabine
An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
Dexamethasone
A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
Doxorubicin Hydrochloride
An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
Etoposide
A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
Mercaptopurine
A purine antagonist, tablet via orally, per standard of care
Methotrexate
A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
Vincristine
A vinca alkaloid, single-use vials via intravenous injection, per standard of care
Interventions
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Blinatumomab
A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
Oncaspar
A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
Cyclophosphamide
An alkylating agent, single-use vial via intravenous infusion, per standard of care
Cytarabine
An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
Dexamethasone
A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
Doxorubicin Hydrochloride
An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
Etoposide
A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
Mercaptopurine
A purine antagonist, tablet via orally, per standard of care
Methotrexate
A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
Vincristine
A vinca alkaloid, single-use vials via intravenous injection, per standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
3.1.3 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.
3.1.6 Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
3.2.5 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.
3.2.7 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.
18 Years
51 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Marlise Luskin, MD
Principal Investigator
Principal Investigators
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Marlise R Luskin, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Central Contacts
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Other Identifiers
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25-533
Identifier Type: -
Identifier Source: org_study_id