Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
NCT ID: NCT05453500
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2023-03-27
2031-03-01
Brief Summary
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Detailed Description
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Patients receive etoposide, doxorubicin, and vincristine intravenously (IV) continuously over 96 hours on days 1-4 of each cycle, cyclophosphamide IV over 1 hour on day 5 of each cycle, prednisone orally (PO) twice daily (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, computed tomography (CT) scan, lumbar puncture and undergo blood sample and cerebrospinal fluid collection throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and every 6 months for 3 years (total follow-up time 5 years).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (DA-EPOCH+/-R, tafasitamab)
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 throughout the trial.
Cyclophosphamide
Given IV
Doxorubicin
Given IV
Etoposide
Given IV
Prednisone
Given PO
Rituximab
Given IV
Tafasitamab
Given IV
Vincristine
Given IV
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo CT scan
Lumbar Puncture
Undergo lumbar puncture
Biospecimen Collection
Undergo blood sample and cerebrospinal fluid collection
Interventions
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Cyclophosphamide
Given IV
Doxorubicin
Given IV
Etoposide
Given IV
Prednisone
Given PO
Rituximab
Given IV
Tafasitamab
Given IV
Vincristine
Given IV
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo CT scan
Lumbar Puncture
Undergo lumbar puncture
Biospecimen Collection
Undergo blood sample and cerebrospinal fluid collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Ryan D. Cassaday
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Noah Pinke
Role: primary
Other Identifiers
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NCI-2022-05225
Identifier Type: REGISTRY
Identifier Source: secondary_id
11008
Identifier Type: OTHER
Identifier Source: secondary_id
RG1122464
Identifier Type: -
Identifier Source: org_study_id