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Anti-metabolites

Pediatric-Inspired Chemotherapy for Leukemia

Phase 2
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain
Age 18 - 60 years
Must not have
Mature B-cell (Burkitt's) ALL
Active serious infections not controlled by antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing whether a chemotherapy regimen used to treat children with acute lymphoblastic leukemia (ALL) is also safe and effective for adults with Ph-negative ALL.

Who is the study for?
Adults aged 18-60 with newly diagnosed Ph Negative Acute Lymphoblastic Leukemia (ALL) who haven't been treated yet. They must have good kidney, liver, and heart function, an ECOG performance status of 0-2, and be willing to use birth control. People with certain other conditions or previous ALL treatments are excluded.
What is being tested?
The trial is testing a 'Pediatric-Inspired' chemotherapy regimen in adults with ALL to see if it's safe and effective. It includes drugs like Daunorubicin and Vincristine among others used in children's treatment protocols for leukemia.
What are the potential side effects?
Possible side effects include nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts (myelosuppression), liver toxicity, allergic reactions to the drugs being tested, fatigue, mouth sores from Methotrexate and potential nerve damage from Vincristine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is a type that has not been treated and does not have the Ph chromosome.
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I am between 18 and 60 years old.
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My kidney function is good, with creatinine levels or clearance within the required range.
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My heart pumps well, with an ejection fraction of 50% or higher.
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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My leukemia is identified as Mature B-cell (Burkitt's).
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I have a serious infection that antibiotics can't control.
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I have another cancer that needs immediate treatment.
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I do not have severe heart or lung conditions.
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I am HIV positive.
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My leukemia is not Philadelphia chromosome positive.
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My condition is a lymphoid blast phase of chronic myeloid leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
rate of molecular remission
Secondary study objectives
complete remission (CR)
disease free survival (DFS) rates
event-free survival (EFS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leukemia PatientsExperimental Treatment12 Interventions
The treatment plan has 6 treatment cycles. The cycle names are listed in the following order: Induction Phase I - Induction Phase II - Intensification I - Re-induction I - Intensification II - Re-induction II Each cycle is given over a period of 4-6 weeks and the interval between them can range between 1-3 weeks. Based the patients medical condition, the doctor may decide to change the timing of the drugs, the interval between the drugs in a cycle, or the interval between the cycles. After receiving all cycles you will continue with a 36 months treatment part that is called Maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved
Vincristine
FDA approved
Prednisone
FDA approved
Pegaspargase
FDA approved
Methotrexate
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Leucovorin
FDA approved
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,517 Total Patients Enrolled
117 Trials studying Leukemia
9,401 Patients Enrolled for Leukemia
ShireIndustry Sponsor
456 Previous Clinical Trials
97,239 Total Patients Enrolled
3 Trials studying Leukemia
1,849 Patients Enrolled for Leukemia
Duke UniversityOTHER
2,424 Previous Clinical Trials
3,066,045 Total Patients Enrolled
15 Trials studying Leukemia
1,377 Patients Enrolled for Leukemia
~3 spots leftby Aug 2025
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