Status:
COMPLETED
Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma
Lead Sponsor:
Mehrdad Abedi, MD
Collaborating Sponsors:
Amgen
Conditions:
Contiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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 de...
Detailed Description
PRIMARY OBJECTIVES: I. Safety and tolerability of administering carfilzomib in combination with hyper-CVAD chemotherapy. II. Recommended dose of carfilzomib in combination with hyper-CVAD chemothera...
Eligibility Criteria
Inclusion
- Understand and voluntarily sign an informed consent form
- 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
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- 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
Key Trial Info
Start Date :
December 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02293109
Start Date
December 17 2015
End Date
January 11 2018
Last Update
March 10 2022
Active Locations (1)
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1
University of California Davis
Sacramento, California, United States, 95817