ALL Backbone in AYAs (NCT07227584) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ALL Backbone in AYAs
67 participantsStarted 2026-04
Plain-language summary
The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
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)
Who can participate
Age range18 Years – 51 Years
SexALL
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Inclusion criteria
✓.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.
✓.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.
Exclusion criteria
✕.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.
What they're measuring
1
Treatment Completion Rate Through Time Point 3 (TP3)
Timeframe: 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
✕.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.