Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma
NCT02293109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-03-10
Summary
This phase I trial studies the side effects and best dose of carfilzomib when given together with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, 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. Giving carfilzomib with combination chemotherapy may kill more cancer cells.
Conditions
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Untreated Adult Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
vincristine sulfate
Given IV
- DRUG
-
doxorubicin hydrochloride
Given IV
- DRUG
-
Given PO
- DRUG
-
methotrexate
Given IV
- DRUG
-
Given IV
- DRUG
-
leucovorin calcium
Given IV or PO
- DRUG
-
methylprednisolone
Given IV
- BIOLOGICAL
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
- collaborator INDUSTRY
-
Mehrdad Abedi, MD
lead OTHER
Principal Investigators
-
Mehrdad Abedi · University of California, Davis
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-17
- Primary Completion
- 2017-12-13
- Completion
- 2018-01-11
Countries
- United States
Study Locations
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