Phase 2
N=54
Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia · Lymphoblastic Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03023046 ↗Enrolled (actual)
54
Serious AEs
60.4%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants With Morphological Complete Response Rate — 27; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Dasatinib (Drug); Doxorubicin (Drug); Etoposide (Drug); Imatinib Mesylate (Drug); Laboratory Biomarker Analysis (Other); Prednisone (Drug); Rituximab (Biological); Vincristine Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Morphological Complete Response Rate |
27; 20 | — |
| PRIMARY Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate |
20; 16; 8; 9; 11; 17 | — |
| SECONDARY Number of Participants With Adverse Events |
44 | — |
| SECONDARY Overall Survival |
70 | — |
| SECONDARY Event-free Survival |
32 | — |
Summary
This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, 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.
Eligibility Criteria
Inclusion Criteria
- Patients must have a confirmed diagnosis of either:
- Acute lymphoblastic leukemia
- Lymphoblastic lymphoma with detectable abnormal blasts in the bone marrow
- 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 (i.e., >= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen, or Ph+ disease
- Total bilirubin = 2.0 mg/dL but with a 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)
- Must agree to the use of effective contraception while on study treatment, 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 for the duration of the study)
- Ability to give informed consent and comply with the protocol
- Anticipated survival of at least 3 months, independent of ALL
Exclusion Criteria
- Patients with Burkitt lymphoma/leukemia
- Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
- Patients with isolated extramedullary disease or with 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
Data sourced from ClinicalTrials.gov (NCT03023046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.