← Back to Search

Enzyme

Chemotherapy for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Daniel J. DeAngelo, MD, PhD

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

Between the ages of 18 to 50 years

Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a cancer drug in adults with a certain kind of leukemia. They're trying to find the best dose and see if it's safe.

Who is the study for?

Adults aged 18-50 with newly diagnosed acute lymphoblastic leukemia (ALL), except mature B-cell ALL, can join. They should be fairly active and healthy otherwise (ECOG status 0-2). Prior treatments like short-term steroids or emergency interventions for leukemia complications are okay, but no other cancer treatments.Check my eligibility

What is being tested?

The trial is testing the safety and best dose of L-asparaginase in adults with ALL. It includes a combination of chemotherapy drugs like doxorubicin, vincristine, methotrexate, and others to see how well patients tolerate this treatment regimen.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, hair loss from chemotherapy drugs; allergic reactions to asparaginase; mouth sores; increased risk of infections due to lowered white blood cell counts; liver problems from medications like methotrexate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old.

Select...

I have been diagnosed with acute lymphoblastic leukemia, not the mature B-cell type.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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, safety and efficacy of the high-risk pediatric treatment regimen in adult patients between the ages of 18 and 50 years

Secondary outcome measures

To determine the safety and optimal dosing of L-asparaginase during the intensification period

Asparaginase

to determine the safety of individualized dosing of E. coli L-asparaginase based upon asparaginase levels

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Only Arm for this studyExperimental Treatment12 Interventions

Only Arm for this study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cytarabine

1997

Completed Phase 3

~10270

doxorubicin

2005

Completed Phase 3

~9130

vincristine

2005

Completed Phase 4

~3840

methotrexate

1997

Completed Phase 3

~9960

leucovorin

2005

Completed Phase 3

~1200

prednisone

1999

Completed Phase 3

~10920

dexamethasone

1995

Completed Phase 3

~9860

hydrocortisone

2006

Completed Phase 3

~1310

asparaginase

1999

Completed Phase 3

~10560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,198,255 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,608 Previous Clinical Trials

11,469,777 Total Patients Enrolled

Queen Elizabeth II Health Sciences CentreOTHER

23 Previous Clinical Trials

14,010 Total Patients Enrolled

Media Library

L-asparaginase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT00136435 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Only Arm for this study

Acute Lymphoblastic Leukemia Clinical Trial 2023: L-asparaginase Highlights & Side Effects. Trial Name: NCT00136435 — Phase 2

L-asparaginase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00136435 — Phase 2

Frequently Asked Questions

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

If someone is under the age of 45, can they participate in this research project?

"According to the qualifications listed, people aged 18-50 are eligible for this trial. There are 775 clinical trials specifically designed for children and 2676 focused on care for elderly patients."

Answered by AI

What other scientific papers have been published on this therapy?

"As of right now, there are 1,720 ongoing clinical studies for this treatment. 459 of those trials are in the third stage. Mishawaka, Indiana has a large number of these active studies, but there are actually 69,944 locations across the globe conducting research for this medication."

Answered by AI

What conditions has this medication been found to be effective in treating?

"This medication is most often used to treat pheochromocytomas. Additionally, it has shown efficacy in treating ulcerative colitis, eye conditions, and varicella-zoster virus acute retinal necrosis."

Answered by AI

How many people are being treated as part of this experiment?

"As of 6/23/2022, this clinical trial is no longer recruiting patients. If you are hoping to participate in a similar study, there are 1551 trials for leukemia and lymphoid cancer that are still seeking participants."

Answered by AI

Does this treatment have any life-threatening side effects?

"While there is evidence that this intervention is safe, it only received a score of 2 because, as a Phase 2 trial, there is no data yet supporting its efficacy."

Answered by AI

Who can sign up to take part in this experiment?

"The ideal candidate for this study is aged 18-50, has leukemia or lymphoid, and ECOG performance status of 0-2. They should also be able to commit to one week of steroids and emergent radiation therapy."

Answered by AI

Are new patients being accepted into this study?

"This particular clinical trial is not recruiting at this time. The original posting was on 6/1/2002, with the most recent edit being on 6/23/2022. However, there are other ongoing studies related to leukemia, lymphoid and 1720 cancer treatment trials that are still admitting patients if you are interested in exploring those options."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study in Adults With Untreated Acute Lymphoblastic Leukemia

Daniel J. DeAngelo, MD, PhD 2002. "A Study in Adults With Untreated Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00136435.

All > Acute Myelogenous Leukemia > All