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Anti-metabolites

Newly diagnosed ALL, LLy, and MPAL patients for Lymphoblastic Lymphoma

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

2013

Completed Phase 4

~3800

Dexamethasone

2007

Completed Phase 4

~2590

Vincristine

2003

Completed Phase 4

~2910

Daunorubicin

2013

Completed Phase 4

~4940

Cytarabine

2016

Completed Phase 3

~3310

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,305,763 Total Patients Enrolled

Seth E. Karol, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

191 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include individuals who are 85 years of age or older?

"Inclusion criteria for this research study include individuals over 12 months old but under the age of 18."

Answered by AI

May I inquire about the criteria for potential participation in this medical study?

"Eligible candidates for this trial must have a diagnosis of acute lymphoblastic leukemia and fall within the age range of 1 year to 18 years. The study aims to recruit approximately 850 individuals meeting these criteria."

Answered by AI

Is the recruitment for this study still ongoing at present?

"According to the information available on clinicaltrials.gov, this specific medical trial is not currently seeking volunteers. The initial posting of this trial was on May 1st, 2024, and the most recent update occurred on February 23rd, 2024. Despite its current inactivity in patient recruitment, it's noteworthy that there are approximately 2838 other trials actively looking for participants at present."

Answered by AI

Do patients with recently identified Acute Lymphoblastic Leukemia, Lymphoma-Associated Hemophagocytic Syndrome, and Mixed Phenotype Acute Leukemia meet the criteria set by the Food and Drug Administration?

"Our research team at Power has rated the safety of treatment for newly diagnosed patients with acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LLy), and mixed-phenotype acute leukemia (MPAL) as a 3 on our scale. This is based on the Phase 4 trial status, indicating that this therapy has been officially sanctioned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

2024. "Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06289673.