Chemotherapy and targeted therapy for newly diagnosed B-ALL
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)
This study tests a new combination of chemotherapy and a targeted therapy to see if it helps people with newly diagnosed B acute lymphoblastic leukemia feel better and fight their cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | rituximab, tafasitamab, chemotherapy, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05453500 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates a chemotherapy regimen (DA-EPOCH+/-R) combined with the targeted therapy tafasitamab for treating newly diagnosed Philadelphia chromosome negative B acute lymphoblastic leukemia (B-ALL). The treatment involves administering a combination of chemotherapy drugs and tafasitamab to assess its effectiveness in halting cancer cell growth. Patients will receive treatment cycles every 21 days for up to 8 cycles, with follow-up assessments conducted for 5 years post-treatment to monitor outcomes and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed CD19+ Ph- B-ALL who are unsuitable for pediatric-inspired regimens.
Not a fit: Patients with other types of leukemia or those who are suitable candidates for pediatric-inspired regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with newly diagnosed Ph- B-ALL.
How similar studies have performed: Other studies have shown promise with similar chemotherapy and targeted therapy combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age 18 years and older) with newly-diagnosed CD19+ Ph- B-ALL * In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., \>= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen * Marrow or blood involvement detectable by MFC * Total bilirubin =\< 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =\< 4.0 x ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =\< 5.0 x ULN and ALT/AST are =\< 8.0 x ULN) * Calculated creatinine clearance of \> 30 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible * As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL) * Ability to give informed consent and comply with the protocol * Anticipated survival of at least 3 months, independent of ALL Exclusion Criteria: * Burkitt lymphoma/leukemia * No prior systemic therapy for ALL except to control acute symptoms and/or hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.) * No isolated extramedullary or known parenchymal central nervous system (CNS) disease * Known hypersensitivity or intolerance to any of the agents under investigation * Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol * May not be pregnant or nursing * Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \[1\] surgically sterilized, or \[2\] postmenopausal \[i.e., a woman who is \> 50 years old or who has not had menses for \>=1 year\], or \[3\] not heterosexually active)
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Ryan D. Cassaday — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Noah Pinke
- Email: ntpinke@fredhutch.org
- Phone: 206-606-4942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.