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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
Must not have
Uncontrolled active infection
Prior history of a cerebrovascular accident or hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 18 and 50 years old.
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I have been diagnosed with acute lymphoblastic leukemia, not the mature B-cell type.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing infections that aren't responding to treatment.
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I have had a stroke or brain bleed in the past.
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I have had pancreatitis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
doxorubicin
2005
Completed Phase 3
~9130
cytarabine
1997
Completed Phase 3
~10270
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
~9520
hydrocortisone
2006
Completed Phase 3
~1310
asparaginase
1999
Completed Phase 3
~10560

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
3,023 Previous Clinical Trials
13,317,849 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,843,366 Total Patients Enrolled
Queen Elizabeth II Health Sciences CentreOTHER
25 Previous Clinical Trials
14,115 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,110 Previous Clinical Trials
358,198 Total Patients Enrolled
Daniel J. DeAngelo, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
186 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
~4 spots leftby Dec 2025
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