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Antimetabolite

Combination Therapy for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Daniel DeAngelo, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will study a new multi-drug chemotherapy regimen for treating Acute Lymphoblastic Leukemia in adults. The regimen includes drugs that have been used to treat pediatric patients in the past, as well as new drugs PEG-asparaginase and E. coli asparaginase. Researchers hope to learn more about the disease and how it responds to standard chemotherapy drugs.

Eligible Conditions

Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment in adult patient 18 year of age or older.

Secondary outcome measures

Disease-free survival, defined as the time from achieving a complete remission to the first of disease recurrence or death, will be estimated using Kaplan-Meier methods.

Overall survival, defined as time from study entry to death from any cause, will be estimated using Kaplan-Meier methods.

To determine the complete response rate at the end of induction therapy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Dexamethasone

FDA approved

Etoposide

FDA approved

Methylprednisone

FDA approved

Hydrocortisone succinate

FDA approved

Cytarabine

FDA approved

Imatinib

FDA approved

Pegaspargase

FDA approved

Doxorubicin

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

Methotrexate

FDA approved

Vincristine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,760 Total Patients Enrolled

NCIC Clinical Trials GroupNETWORK

189 Previous Clinical Trials

144,729 Total Patients Enrolled

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,243 Total Patients Enrolled

Media Library

6-MP (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT00476190 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Arm B, Arm A

Acute Lymphoblastic Leukemia Clinical Trial 2023: 6-MP Highlights & Side Effects. Trial Name: NCT00476190 — Phase 2

6-MP (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00476190 — Phase 2

Frequently Asked Questions

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

If I meet the qualifications, may I enroll in this clinical research?

"This leukemia study has space for 112 participants that are aged between 18 and 50. To be eligible, potential patients must have acute lymphoblastic leukemia (ALL) which can be diagnosed by certain characteristics including the presence of surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)."

Answered by AI

At how many total locations is this trial being conducted?

"Enrollment for this research project is currently open at Hopital Maisonneuve Rosemont in Columbus, Ohio, Ohio State University Medical Center in Boston, Massachusetts, Dana-Farber Cancer Institute in Winnipeg, Manitoba as well as 15 other locations."

Answered by AI

Are we still enrolling people for this clinical trial?

"Unfortunately, this study is not currently recruiting patients. The listing was first posted on April 1st, 2007 and updated as recently as July 25th, 2022. If you are interested in other trials, there are 513 active studies for leukemia, lymphocytic, acute, l1 and 1938 6-MP trials admitting participants."

Answered by AI

What are some of the main illnesses that 6-MP has been shown to help?

"6-MP is a medication that is most often used to treat macular edema. Other conditions that 6-MP can help manage include pheochromocytomas, ulcerative colitis, and certain eye disorders."

Answered by AI

Are there any noted side effects to 6-MP?

"While 6-MP has not been proven effective in Phase 2 trials, there is evidence that it is safe to use. Therefore, our team at Power gave it a score of 2."

Answered by AI

Are the subjects of this research project restricted to those over 30 years old?

"According to the inclusion criteria, only patients aged 18-50 can participate in this trial. Out of the 751 trials for people under 18 and 1901 trials for those over 65, this is the only one that falls within the specified age range."

Answered by AI

What other similar research has been conducted in the past?

"Alfacell completed the first study on 6-MP in 1997, which then allowed the drug to progress to Phase 3 trials. There are currently 1938 active studies being conducted on 6-MP in 87 different countries."

Answered by AI

How many people have been chosen to participate in this experiment?

"Unfortunately, this particular clinical trial is no longer actively recruiting patients. It was initially posted on April 1st, 2007 but the last update was on July 25th, 2022. There are 513 other trials for leukemia, lymphocytic, acute, l1 and 1938 6-MP trials that are still looking for participants."

Answered by AI

What other scientific investigations have there been of 6-MP?

"The first 6-MP clinical trial was at Spectrum Health Hospital - Butterworth Campus in 1997. As of today, there have been 3554 completed trials and 1938 studies are still ongoing. The majority of these live studies are based in Columbus, Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ALL Adult Consortium Trial: Adult ALL Trial

Daniel J. DeAngelo, MD, PhD 2007. "ALL Adult Consortium Trial: Adult ALL Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00476190.

All > Gleevec