ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02042950
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if carfilzomib can help control relapsed or refractory MCL. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Carfilzomib Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Actual Study Start Date : July 14, 2014
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Carfilzomib

Arm Intervention/treatment
Experimental: Carfilzomib
Carfilzomib given at a dose of 20*/56 mg/m^2 (* CFZ 20 mg/m2 by vein on Days 1 and 2 in Cycle 1 followed by 56 mg/m^2 for each subsequent dose thereafter) on days 1 and 2, 8 and 9, 15 and 16 of a 28-day cycle (following cycle 12 carfilzomib given on days 1 and 2 and 15 and 16 only).
Drug: Carfilzomib
Starting dose: 20 mg/m2 by vein on Days 1 and 2 in Cycle 1 followed by 56 mg/m^2 for each subsequent dose thereafter) on days 1 and 2, 8 and 9, 15 and 16 of a 28-day cycle (following cycle 12 carfilzomib given on days 1 and 2 and 15 and 16 only).




Primary Outcome Measures :
  1. Overall Response Rate of Carfilzomib [ Time Frame: 4 months ]
    Overall response (OR: complete response + partial response) at 4 cycles monitored using the Bayesian stopping boundaries calculated based on beta-binomial distribution. Participants evaluated for disease progression and response according to the Revised Response Criteria for Malignant Lymphoma.

  2. Toxicity of Carfilzomib [ Time Frame: 1 month ]

    Toxicity monitored using the Bayesian stopping boundaries calculated based on beta-binomial distribution. Toxicity defined as the following toxicities observed during cycle 1 (28 days) of treatment:

    Non-hematologic:

    • ≥Grade 2 neuropathy with pain
    • ≥Grade 3 non-hematologic toxicity (excluding nausea, vomiting, and diarrhea)
    • ≥Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
    • ≥Grade 4 fatigue persisting for > 7 days
    • Treatment delay greater than 21 days for toxicity

    Hematologic:

    • Grade 4 neutropenia [absolute neutrophil count (ANC) < 500/mm3] lasting for > 7 days
    • Febrile neutropenia (ANC < 1,000/mm3 with a fever ≥38.3°C)
    • Grade 4 thrombocytopenia (<25,000/mm3) that persists for ≥ 7 days, despite holding treatment
    • Treatment delay greater than 21 days for toxicity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of mantle cell lymphoma.
  2. Patients must have relapsed or refractory MCL.
  3. Understand and voluntarily sign an IRB-approved informed consent form.
  4. Age >/= 18 years at the time of signing the informed consent.
  5. Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  7. Serum bilirubin <1.5 mg/dl and Creatinine Clearance >/= 30 mL/min, platelet count >50,000/mm^3 and absolute neutrophil count (ANC) > 1,000/mm^3. [Patients who have bone marrow infiltration by MCL are eligible if their ANC is ≥ 500/mm^3 (growth factor allowed) or their platelet level is equal to or > than 30,000/mm^3.]. AST (SGOT) and ALT (SGPT) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present. Uric acid within normal limits.
  8. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test within 30 days of initiation of therapy. * A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  9. FCBP must agree to use a highly-effective form of birth control while taking the study drug and for 1 month after the last dose of study drug. Highly-effective forms of birth control include implants, injectables, birth control pills with 2 hormones, some intrauterine devices (IUDs), or having a sterilized partner. The type of birth control used must be discussed with and approved by the attending physician prior to initiation of study drug.
  10. Males must agree to use a condom with spermicide every time they have sex during the study and for 3 months after the last dose of study drug. They also must agree to not donate sperm during the study and for 3 months after the last dose of study drug.
  11. Patients must be willing to receive transfusions of blood products.

Exclusion Criteria:

  1. Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females.
  3. Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation
  4. All patients with active central nervous system lymphoma.
  5. Significant neuropathy (Grades 3 - 4, or Grade 2 with pain) within 14 days prior to enrollment.
  6. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
  7. Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis to ascites requiring paracentesis.
  8. Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).
  9. Patients with symptomatic bradycardia (heart rate < 50 bpm, hypotension, light-headedness, syncope).
  10. Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g. donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment. Prior allogeneic SCT within 16 weeks or autologous SCT within 8 weeks of initiation of therapy.
  11. Patients with New York Health Association (NYHA) Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities, including but not limited to atrial fibrillation, atrioventricular (AV) block block, QT prolongation, sick sinus syndrome, ventricular tachycardia, as these patients may be at greater risk for cardiac complication, per carfilzomib labeling.
  12. The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient's health and survival, than of the MCL, within the subsequent 6 months at the time of consent. Investigator discretion is allowed.
  13. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment.
  14. Patients who have received any previous Carfilzomib treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042950


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Onyx Therapeutics, Inc.
Investigators
Principal Investigator: Hun J. Lee, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02042950     History of Changes
Other Study ID Numbers: 2013-0259
NCI-2014-01271 ( Registry Identifier: NCI CTRP )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Mantle Cell Lymphoma
MCL
Relapsed
Refractory
Carfilzomib

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin