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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

Approved for 50 Other Conditions

No Placebo-Only Group

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.

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.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Residual Tumor

Secondary study objectives

Event-free survival (EFS)

Incidence of adverse events

Overall survival (OS)

+2 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (DA-EPOCH+/-R, tafasitamab)Experimental Treatment12 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. Patients undergo bone marrow aspiration or biopsy, CT scan, lumbar puncture and undergo blood sample and cerebrospinal fluid collection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumbar Puncture

2016

Completed Phase 3

~510

Computed Tomography

2017

Completed Phase 2

~2790