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Alkylating agents
Chemotherapy + Targeted Therapy for Acute Lymphoblastic Leukemia
Phase 2
Recruiting
Led By Ryan D. Cassaday
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a new chemotherapy regimen with the addition of targeted therapy for the treatment of patients with newly diagnosed Philadelphia chromosome negative B acute lymphoblastic leukemia.
Who is the study for?
This trial is for adults over 18 with newly-diagnosed Ph- B-ALL who can't use pediatric treatments, often due to age or other concerns. Participants need functioning kidneys and liver (with specific limits on enzyme levels), no severe blood count issues for subsequent treatment cycles, a performance status indicating they're not too sick to participate, and an expected survival beyond 3 months.Check my eligibility
What is being tested?
The study tests DA-EPOCH+/-R chemotherapy combined with tafasitamab against the same chemo without tafasitamab in treating Ph- B-ALL. The goal is to see if adding the targeted therapy of tafasitamab improves outcomes by slowing cancer cell growth more effectively than chemotherapy alone.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and chills, low blood counts leading to increased infection risk or bleeding problems, nausea, hair loss from chemotherapy drugs, and potential liver toxicity.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Residual Tumor
Secondary outcome measures
Event-free survival (EFS)
Incidence of adverse events
Overall survival (OS)
+2 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (DA-EPOCH+/-R, tafasitamab)Experimental Treatment8 Interventions
Patients receive etoposide, doxorubicin, and vincristine IV continuously over 96 hours on days 1-4 of each cycle, cyclophosphamide IV over 1 hour on day 5 of each cycle, prednisone PO BID on days 1-5 of each cycle, and tafasitamab IV weekly on days 1, 8, and 15 of each cycle. CD20 positive patients also receive rituximab IV per guidelines on days 1 or 5 of each cycle. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Prednisone
FDA approved
Tafasitamab
FDA approved
Cyclophosphamide
FDA approved
Daunorubicin
FDA approved
Etoposide
FDA approved
Vincristine
FDA approved
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,743 Previous Clinical Trials
1,847,840 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
366 Previous Clinical Trials
55,385 Total Patients Enrolled
Ryan D. CassadayPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have only received emergency treatment for my acute lymphoblastic leukemia.I have been diagnosed with Burkitt lymphoma/leukemia.I am an adult with a new diagnosis of a specific type of leukemia.My kidney function, measured by creatinine clearance, is above 30 ml/min.I can care for myself but may not be able to do active work due to my condition.My blood counts do not need to be normal to start treatment, but must improve for more treatment.I am considered unsuitable for a pediatric treatment plan due to my age or concerns about side effects.I do not have cancer that has spread to my brain or spinal cord.I am a woman and not pregnant, or cannot become pregnant due to surgery, menopause, or not being sexually active with men.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (DA-EPOCH+/-R, tafasitamab)
Awards:
This trial has 2 awards, including:- Approved for 50 Other Conditions - This treatment demonstrated efficacy for 50 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Rituximab likely to cause any harm to patients?
"There is some data supporting Rituximab's safety, but none yet for efficacy. It was given a score of 2."
Answered by AI
Are there any available appointments for this experimental procedure?
"As of July 11th, 2022, this clinical trial is no longer recruiting patients. It was initially posted on January 1st, 2023 but has not been updated in over 6 months. Although this study is now closed to new applicants, there are 1549 other trials that are still open and actively recruiting candidates."
Answered by AI
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