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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

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 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)

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
Methotrexate
2019
Completed Phase 4
~4400
Dexamethasone
2007
Completed Phase 4
~2640
Vincristine
2003
Completed Phase 4
~2970
Daunorubicin
2013
Completed Phase 4
~5040
Cytarabine
2016
Completed Phase 3
~3330

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
442 Previous Clinical Trials
5,308,019 Total Patients Enrolled
Seth E. Karol, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
191 Total Patients Enrolled
~567 spots leftby May 2034
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