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

NCT02042950 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0259NCI-2014-01271
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Lymphoma; Mantle Cell Lymphoma; MCL; Relapsed; Refractory; Carfilzomib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate of Carfilzomib

  To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.

  21 months

Other Outcomes (2)

• Toxicity of Carfilzomib

  21 months

• Post Treatment

  21 months

Study Arms (1)

Carfilzomib

EXPERIMENTAL

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

Interventions

Carfilzomib DRUG

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).

Carfilzomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of mantle cell lymphoma.
• Patients must have relapsed or refractory MCL.
• Understand and voluntarily sign an IRB-approved informed consent form.
• Age \>/= 18 years at the time of signing the informed consent.
• Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• 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.
• 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).
• 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.
• 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.
• Patients must be willing to receive transfusions of blood products.

You may not qualify if:

• 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.
• Pregnant or breast feeding females.
• 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
• All patients with active central nervous system lymphoma.
• Significant neuropathy (Grades 3 - 4, or Grade 2 with pain) within 14 days prior to enrollment.
• Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
• 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.
• Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).
• Patients with symptomatic bradycardia (heart rate \< 50 bpm, hypotension, light-headedness, syncope).
• 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.
• 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.
• 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.
• Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment.
• Patients who have received any previous Carfilzomib treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Onyx Therapeutics, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell; Recurrence

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Hun Ju Lee/ Assistant Professor, Lymphoma/Myeloma
• Organization: UT MD Anderson Cancer Center

hunlee@mdanderson.org

(713) 794-1829

Study Officials

• Hun J. Lee, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: July 14, 2014
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: May 1, 2019
• Results First Posted: May 1, 2019

Record last verified: 2019-04

Locations

US (1)