LymphomaPhase 2NCT02042950
A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
A Phase 2 study testing Carfilzomib in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Carfilzomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2014to 20 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
Study Drug Administration:
If participant is found to be eligible for this study, they will begin the first cycle of treatment with carfilzomib. Each cycle is 28 days.
On Days 1, 2, 8, 9, 15, and 16 of Cycles 1-12:
- Participant will receive carfilzomib by vein over 30 minutes. The first 2 doses participant receives may be lower than later doses. This is to reduce the risk of an allergic reaction.
On Days 1, 2, 15, and 16 of Cycles 13 and beyond:
- Participant will receive carfilzomib by vein over 30 minutes.
Participant should drink at least 6-8 cups (8 ounces each) of fluid per day starting 2 days before their first day of treatment and for as long as their doctor asks them to. During Cycles 1 and 2, participant will receive fluids by vein before and after their dose of carfilzomib.
Before participant receives carfilzomib, they will be given standard drugs (such as allopurinol, dexamethasone, antibiotics, anti-fungals, and/or anti-virals) to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.
When participant receives the drugs during Cycle 1 and on Day 1 of Cycle 2, they will be monitored for side effects for 1 hour after they receive the study drug.
Study Visits:
On Day 1 of all cycles:
- Participant will have a physical exam.
- Participant will have a neurological exam to check for weakness, numbness and pain in their hands and feet.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If participant's doctor thinks it is needed, they will have a bone marrow biopsy and/or aspiration to check the status of the disease.
- If participant's doctor thinks it is needed, they will have an ECHO or a MUGA.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test. (Cycles 2 and beyond only)
On Days 2, 9, and 16 of all cycles:
- Participant's vital signs will be measured.
On Days 8 and 15 of all cycles:
- Participant will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test.
On Day 1 of Cycles 2, 4, 6, and so on up to Cycle 12, then every 3 cycles after that:
- If the study doctor thinks it is needed, participant will have a CT scan, MRI, PET scan, and/or PET/CT scan to check the status of the disease.
- If the study doctor thinks it is needed, participant will have a gastrointestinal endoscopy or colonoscopy.
Length of Study:
Participant may continue taking the study drug for up to 3 years. Participant will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation on the study will be over once they have completed the long term follow-up phone calls.
End-of-Treatment Visit:
Within about 30 days, after participant finishes taking the study drug they will return to the clinic for the following tests and procedures:
- Participant will have a physical exam.
- Participant will have a neurological exam to check for weakness, numbness and pain in their hands and feet.
- Participant will have an EKG to check their heart function.
- Blood (about 3-5 tablespoons) will be drawn for routine tests and to check the status of the disease.
- Participant will have a CT scan and/or x-ray to check the status of the disease.
- Participant will have a PET/CT scan to check the status of the disease.
- If participant's doctor thinks it is needed, they will have a bone marrow biopsy and aspiration
- If participant's doctor thinks it is needed, they will have a colonoscopy/gastrointestinal endoscopy.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test.
Long Term Follow-Up:
After participant's end-of-treatment visit, they will be called every 6 months for 1 year to see how they are doing and to find out about any other treatments they have received since they stopped study treatment. These calls will take about 2-3 minutes. In addition to the phone calls, participant's medical records may be reviewed as well.
This is an investigational study. Carfilzomib is FDA approved and commercially available for the treatment of certain types of multiple myeloma. This drug is investigational for the treatment of MCL.
Up to 60 participants will be enrolled on this study. All will be enrolled at MD Anderson.
- Conditions
- Lymphoma
- Being tested
- Carfilzomib
- Keywords
- Lymphoma, Mantle Cell Lymphoma, MCL, Relapsed, Refractory, Carfilzomib
- Medical subject headings
- Lymphoma, Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate of Carfilzomib
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start14 Jul 2014
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Why it stopped: Terminated due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Onyx Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Hun J. Lee, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042950
- Sponsor's protocol ID
- 2013-0259
- Other IDs
- NCI-2014-01271
- Status last verified
- Apr 2019
- First submitted
- 21 Jan 2014
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Carfilzomib in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02042950
- Acronym / sponsor ID
- 2013-0259
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Mantle Cell Lymphoma, MCL, Relapsed, Refractory, Carfilzomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Onyx Therapeutics, Inc.
- Study start
- 14 Jul 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Drug Administration:
If participant is found to be eligible for this study, they will begin the first cycle of treatment with carfilzomib. Each cycle is 28 days.
On Days 1, 2, 8, 9, 15, and 16 of Cycles 1-12:
- Participant will receive carfilzomib by vein over 30 minutes. The first 2 doses participant receives may be lower than later doses. This is to reduce the risk of an allergic reaction.
On Days 1, 2, 15, and 16 of Cycles 13 and beyond:
- Participant will receive carfilzomib by vein over 30 minutes.
Participant should drink at least 6-8 cups (8 ounces each) of fluid per day starting 2 days before their first day of treatment and for as long as their doctor asks them to. During Cycles 1 and 2, participant will receive fluids by vein before and after their dose of carfilzomib.
Before participant receives carfilzomib, they will be given standard drugs (such as allopurinol, dexamethasone, antibiotics, anti-fungals, and/or anti-virals) to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.
When participant receives the drugs during Cycle 1 and on Day 1 of Cycle 2, they will be monitored for side effects for 1 hour after they receive the study drug.
Study Visits:
On Day 1 of all cycles:
- Participant will have a physical exam.
- Participant will have a neurological exam to check for weakness, numbness and pain in their hands and feet.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If participant's doctor thinks it is needed, they will have a bone marrow biopsy and/or aspiration to check the status of the disease.
- If participant's doctor thinks it is needed, they will have an ECHO or a MUGA.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test. (Cycles 2 and beyond only)
On Days 2, 9, and 16 of all cycles:
- Participant's vital signs will be measured.
On Days 8 and 15 of all cycles:
- Participant will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test.
On Day 1 of Cycles 2, 4, 6, and so on up to Cycle 12, then every 3 cycles after that:
- If the study doctor thinks it is needed, participant will have a CT scan, MRI, PET scan, and/or PET/CT scan to check the status of the disease.
- If the study doctor thinks it is needed, participant will have a gastrointestinal endoscopy or colonoscopy.
Length of Study:
Participant may continue taking the study drug for up to 3 years. Participant will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation on the study will be over once they have completed the long term follow-up phone calls.
End-of-Treatment Visit:
Within about 30 days, after participant finishes taking the study drug they will return to the clinic for the following tests and procedures:
- Participant will have a physical exam.
- Participant will have a neurological exam to check for weakness, numbness and pain in their hands and feet.
- Participant will have an EKG to check their heart function.
- Blood (about 3-5 tablespoons) will be drawn for routine tests and to check the status of the disease.
- Participant will have a CT scan and/or x-ray to check the status of the disease.
- Participant will have a PET/CT scan to check the status of the disease.
- If participant's doctor thinks it is needed, they will have a bone marrow biopsy and aspiration
- If participant's doctor thinks it is needed, they will have a colonoscopy/gastrointestinal endoscopy.
- If participant is able to become pregnant, they will have a blood (about 1½ tablespoons) or urine pregnancy test.
Long Term Follow-Up:
After participant's end-of-treatment visit, they will be called every 6 months for 1 year to see how they are doing and to find out about any other treatments they have received since they stopped study treatment. These calls will take about 2-3 minutes. In addition to the phone calls, participant's medical records may be reviewed as well.
This is an investigational study. Carfilzomib is FDA approved and commercially available for the treatment of certain types of multiple myeloma. This drug is investigational for the treatment of MCL.
Up to 60 participants will be enrolled on this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib | Experimental | Drug: CarfilzomibCarfilzomib 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarfilzomibStarting 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). | Drug | Carfilzomib |
Primary outcome
Overall Response Rate of Carfilzomib
Time frame: 21 months
To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hun J. Lee, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carfilzomib in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate of Carfilzomib (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.