RecruitingPhase 2NCT05453500

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leukemia (B-ALL)


Sponsor

University of Washington

Enrollment

30 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab \[DA-EPOCH+/-R\]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining a targeted antibody (tafasitamab, which attacks a protein on leukemia cells) with standard chemotherapy for adults who are newly diagnosed with a specific type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that lacks the Philadelphia chromosome. **You may be eligible if...** - You are 18 or older with a new diagnosis of CD19-positive B-cell ALL - You are not considered a good candidate for the most intensive "pediatric-inspired" chemotherapy regimens (perhaps due to older age or other health factors) - Your liver, kidney, and blood counts are adequate - Your cancer is confirmed to be Philadelphia chromosome-negative **You may NOT be eligible if...** - Your ALL has the Philadelphia chromosome mutation - You have received prior treatment for this leukemia - Your liver or kidney function is severely impaired - You have active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin

Given IV

DRUGEtoposide

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

BIOLOGICALTafasitamab

Given IV

DRUGVincristine

Given IV

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREBiospecimen Collection

Undergo blood sample and cerebrospinal fluid collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT05453500


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