Chemotherapy and Targeted Therapy for Treating Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05453500

Provider View

This clinical trial is exploring a combination of chemotherapy and a targeted therapy called tafasitamab to treat patients with a specific type of newly diagnosed leukemia. The study aims to see if adding tafasitamab to the chemotherapy regimen can improve treatment outcomes.

Patient Parameters

Program Overview

This study is testing a combination of chemotherapy drugs and a targeted therapy called tafasitamab for patients with a type of leukemia known as Philadelphia chromosome negative B acute lymphoblastic leukemia (Ph- B-ALL). Chemotherapy works by stopping cancer cells from growing and spreading, while tafasitamab helps the body slow or stop the growth of these cells. The study aims to find out if this combination is more effective than chemotherapy alone in treating this type of leukemia.

Description

In this study, patients will receive a combination of chemotherapy drugs and the targeted therapy tafasitamab. The chemotherapy drugs include etoposide, doxorubicin, and vincristine, which are given through an IV over four days, cyclophosphamide given through an IV on the fifth day, and prednisone taken by mouth twice a day for five days. Tafasitamab is given through an IV once a week. If patients have a specific marker (CD20), they will also receive another drug called rituximab. This treatment cycle repeats every 21 days for up to eight cycles, as long as the disease does not progress and side effects are manageable. Patients will also undergo various tests, including bone marrow biopsies, CT scans, and blood and spinal fluid tests. After completing the treatment, patients will have follow-up visits every three months for two years and then every six months for three more years, totaling five years of follow-up.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed Philadelphia chromosome negative B acute lymphoblastic leukemia (Ph- B-ALL) that is CD19 positive.
  • Patients who are not suitable for a pediatric-inspired treatment plan, possibly due to age (40 years or older) or other practical or health concerns.
  • Cancer involvement detectable in bone marrow or blood.
  • Total bilirubin level within acceptable limits, unless due to specific conditions like Gilbert's disease.
  • Liver enzyme levels within specified limits, with some exceptions for liver involvement by leukemia.
  • Kidney function with creatinine clearance above 30 ml/min.
  • No specific blood count requirements for starting treatment, but recovery is needed for further cycles.
  • Performance status score of 0 to 2, or 3 if due to leukemia.
  • Ability to understand and consent to the study.
  • Expected survival of at least three months, not related to leukemia.

Exclusion Criteria

  • Diagnosis of Burkitt lymphoma/leukemia.
  • No previous systemic treatment for leukemia, except for managing acute symptoms.
  • No isolated or known central nervous system disease.
  • No known allergies to the study drugs.
  • No other medical or psychiatric conditions that would make participation unsafe.
  • Cannot be pregnant or breastfeeding. Women must take a pregnancy test unless they are unlikely to conceive due to surgical sterilization, menopause, or not being sexually active.

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