Pediatric-Inspired Chemotherapy for Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Jae Park, MD - MSK Leukemia Specialist ...

Overseen byJae Park, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.

Eligibility Criteria

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.

Inclusion Criteria

My liver is functioning well, with specific blood test levels within normal limits.

I agree to use effective birth control during and for 4 months after treatment.

I have ALL with CNS involvement and can get additional treatments for it.

+8 more

Exclusion Criteria

I have had treatment for ALL, but only steroids or hydroxyurea.

Pregnant women or women who are breast-feeding

My leukemia is identified as Mature B-cell (Burkitt's).

+7 more

Participant Groups

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.

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.