Combination Therapy for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byDaniel DeAngelo, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL\>

Eligibility Criteria

This trial is for adults aged 18 to 50 with Acute Lymphoblastic Leukemia, but not the mature B-cell type. Participants should be new to leukemia treatment, except possibly short-term steroids or emergency treatments. It's not for those with mental illnesses affecting consent/follow-up, pregnant/breastfeeding women, HIV-positive individuals, or people with secondary ALL.

Inclusion Criteria

Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)

Age 18.00-50.99 years

Exclusion Criteria

You cannot have had any treatment for leukemia, except for short-term use of steroids, emergency radiation therapy to the chest area, or temporary measures to reduce your white blood cell count.

You have a mental illness that may make it hard for you to understand the study or follow the treatment plan.

You are pregnant or breastfeeding.

See 2 more

Treatment Details

Interventions

6-MP (Antimetabolite)
Cyclophosphamide (Alkylating agent)
Cytarabine (Antimetabolite)
Dexamethasone (Corticosteroid)
Doxorubicin (Topoisomerase II Inhibitor)
E. coli Asparaginase (Enzyme)
Etoposide (Topoisomerase II Inhibitor)
Hydrocortisone Sodium Succinate (Corticosteroid)
Imatinib (Tyrosine Kinase Inhibitor)
Methotrexate (Antimetabolite)
Methylprednisone (Corticosteroid)
PEG-Asparaginase (Enzyme)
Radiation Therapy (Radiation)
Vincristine (Vinca Alkaloid)

Trial OverviewThe study tests a multi-drug chemotherapy regimen used in children on adults with ALL and adds PEG-asparaginase and E. coli asparaginase drugs. The goal is to assess safety and effectiveness of this combination therapy including intravenous administration of these drugs.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment14 Interventions

Failure to achieve complete remission after the Induction Phase

Group II: Arm AExperimental Treatment14 Interventions

Complete remission achieved after Induction Phase