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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
1,110 Previous Clinical Trials
358,186 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
144,729 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,023 Previous Clinical Trials
13,317,837 Total Patients Enrolled
Boston Children's HospitalOTHER
788 Previous Clinical Trials
5,582,459 Total Patients Enrolled
Daniel DeAngelo, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have had any treatment for leukemia, except for short-term use of steroids, emergency radiation therapy to the chest area, or temporary measures to reduce your white blood cell count.You have a mental illness that may make it hard for you to understand the study or follow the treatment plan.You are pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.