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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

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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