Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma
NCT ID: NCT02293109
Last Updated: 2022-03-10
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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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2015-12-17
2018-01-11
Brief Summary
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Detailed Description
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I. Safety and tolerability of administering carfilzomib in combination with hyper-CVAD chemotherapy.
II. Recommended dose of carfilzomib in combination with hyper-CVAD chemotherapy for the future phase II trial.
SECONDARY OBJECTIVES:
I. Rate of remission after 2nd and 4th cycles. II. Incidence of minimal residual disease by flow cytometry at 4th cycle.
OUTLINE: This is a dose escalation study of carfilzomib.
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 0, 1, 7, and 8. Patients also receive hyper-CVAD comprising cyclophosphamide IV over 2 hours every 12 hours for 6 doses beginning on day 1, vincristine sulfate IV on days 4 and 11, doxorubicin hydrochloride IV over 2-24 hours on day 4, and dexamethasone orally (PO) on days 1-4 and 11-14 (courses 1 and 3) and methotrexate IV over 24 hours on day 1, cytarabine IV over 2 hours every 12 hours for 4 doses starting on day 2, leucovorin calcium IV or PO every 6 hours beginning 36 hours after the start of methotrexate infusion, and methylprednisolone IV every 12 hours for 6 doses beginning on day 1 (courses 2 and 4). Patients with cluster of differentiation (CD)20 positive disease also receive rituximab twice daily on days 1 and 11 of courses 1 and 3 and days 1 and 8 of courses 2 and 4. Treatment repeats every 3-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 28 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (carfilzomib and hyper-CVAD)
Patients receive carfilzomib IV over 30 minutes on days 0, 1, 7, and 8. Patients also receive hyper-CVAD comprising cyclophosphamide IV over 2 hours every 12 hours for 6 doses beginning on day 1, vincristine sulfate IV on days 4 and 11, doxorubicin hydrochloride IV over 2-24 hours on day 4, and dexamethasone PO on days 1-4 and 11-14 (courses 1 and 3) and methotrexate IV over 24 hours on day 1, cytarabine IV over 2 hours every 12 hours for 4 doses starting on day 2, leucovorin calcium IV or PO every 6 hours beginning 36 hours after the start of methotrexate infusion, and methylprednisolone IV every 12 hours for 6 doses beginning on day 1 (courses 2 and 4). Patients with CD20 positive disease also receive rituximab twice daily on days 1 and 11 of courses 1 and 3 and days 1 and 8 of courses 2 and 4. Treatment repeats every 3-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
doxorubicin hydrochloride
Given IV
dexamethasone
Given PO
methotrexate
Given IV
cytarabine
Given IV
leucovorin calcium
Given IV or PO
methylprednisolone
Given IV
rituximab
laboratory biomarker analysis
Correlative studies
Interventions
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carfilzomib
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
doxorubicin hydrochloride
Given IV
dexamethasone
Given PO
methotrexate
Given IV
cytarabine
Given IV
leucovorin calcium
Given IV or PO
methylprednisolone
Given IV
rituximab
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to adhere to the study visit schedule and other protocol requirements
* Newly diagnosed acute lymphoblastic leukemia/lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (3 if it is directly disease related and is expected to get better if the acute lymphoblastic leukemia/lymphoma \[ALL\] is under control)
* Left ventricular ejection fraction (LVEF) \> 40%
* Total bilirubin =\< 3 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.5 x upper limit of normal
* Creatinine clearance (CrCl) \>= 45 mL/minute within 7 days prior to enrollment either measured or calculated using a standard formula (eg, Cockcroft and Gault); in cases that creatinine clearance cannot be measured accurately, 24 hour urine can be used
* Disease free of other malignancies beside the ALL at the time of the study
* Male subjects must agree to practice contraception
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 24 hours prior to the initiation of the study and they must agree to ongoing pregnancy testing and to practice contraception
Exclusion Criteria
* Pregnant or breast feeding females
* Active congestive heart failure (New York Heart Association \[NYHA\] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention
* Unstable angina or myocardial infarction within 6 months prior to enrollment, NYHA class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker
* Uncontrolled hypertension, uncontrolled pulmonary hypertension or uncontrolled diabetes within 14 days prior to enrollment
* Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Use of any other experimental drug or therapy within 14 days of baseline
* Known history of allergy to Captisol®
* Known sero-positive for active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are sero-positive because of hepatitis B virus vaccine are eligible
* Breakpoint cluster region-Abelson positive (BCR-ABL +) patients will be excluded from the study
18 Years
64 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Mehrdad Abedi, MD
OTHER
Responsible Party
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Mehrdad Abedi, MD
Principal Investigator
Principal Investigators
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Mehrdad Abedi
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis
Sacramento, California, United States
Countries
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Other Identifiers
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UCDCC#246
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCDCC#246
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-02245
Identifier Type: REGISTRY
Identifier Source: secondary_id
660258
Identifier Type: -
Identifier Source: org_study_id
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