ALL Backbone in AYAs

  • STATUS
    Recruiting
  • End date
    Jul 31, 2035
  • participants needed
    67
  • sponsor
    Dana-Farber Cancer Institute
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Updated on 11 February 2026
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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)

Description

This Phase 2, single-arm research study is to evaluate a chemotherapy regiment the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).

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.

Details
Condition Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Negative Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia (ALL), Leukemia
Age 18years - 51years
Clinical Study IdentifierNCT07227584
SponsorDana-Farber Cancer Institute
Last Modified on11 February 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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