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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults aged 18 to 50 with Acute Lymphoblastic Leukemia, but not the mature B-cell type. Participants should be new to leukemia treatment, except possibly short-term steroids or emergency treatments. It's not for those with mental illnesses affecting consent/follow-up, pregnant/breastfeeding women, HIV-positive individuals, or people with secondary ALL.
What is being tested?
The study tests a multi-drug chemotherapy regimen used in children on adults with ALL and adds PEG-asparaginase and E. coli asparaginase drugs. The goal is to assess safety and effectiveness of this combination therapy including intravenous administration of these drugs.
What are the potential side effects?
Possible side effects include reactions at the injection site from PEG-asparaginase and E. coli asparaginase, nausea, hair loss from chemotherapy drugs like Doxorubicin and Cyclophosphamide, increased risk of infections due to immune system suppression by Dexamethasone and other steroids.

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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Methylprednisone
FDA approved
Cyclophosphamide
FDA approved
Hydrocortisone succinate
FDA approved
Dexamethasone
FDA approved
Etoposide
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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,125 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
144,729 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,012 Previous Clinical Trials
13,309,159 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
~6 spots leftby Nov 2025
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