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Anti-metabolites

Combination Therapy for Acute Lymphoblastic Leukemia

Phase 4

Waitlist Available

Led By Seth E. Karol, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 5 years from study entry

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to provide effective treatment for patients with B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) while determining their risk

Who is the study for?

This trial is for children and teens aged 1 to nearly 19 with newly diagnosed acute leukemia or lymphoma, including ALL with significant bone marrow involvement, LLy with less than 25% bone marrow blasts, or MPAL. It's not for those who are pregnant/breastfeeding, have had certain cancer treatments already (except limited cases), are ineligible for related studies, can't consent, or have specific pre-existing conditions.

What is being tested?

The study tests initial therapy while determining the risk category of B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Leukemia. It involves drugs like Dexamethasone and Vincristine among others. The aim is to gather data on the disease and survival rates while creating a database of genomic/clinical information.

What are the potential side effects?

Possible side effects include weakened immune system leading to infections; mouth sores; nausea; vomiting; hair loss; nerve damage causing numbness or tingling in hands and feet; muscle weakness; increased risk of bleeding due to low blood cell counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 5 years from study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 5 years from study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 5 years from study entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete data within the INITIALL database

Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).

Secondary study objectives

Event Free Survival (EFS)

Overall Survival (OS)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Newly diagnosed ALL, LLy, and MPAL patientsExperimental Treatment6 Interventions

All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Vincristine

2003

Completed Phase 4

~2970