Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 1NCT01336920
Carfilzomib in Treating Patients With Relapsed or Refractory T-Cell Lymphoma
A Phase 1 study testing carfilzomib in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by University of Nebraska at 3 sites in United States.
Trial summary
This phase I trial studies the side effects and best dose of carfilzomib in treating patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- carfilzomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jun 2011to 1 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed and refractory PTCL, including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell leukemia/lymphoma (ATLL), NK-cell lymphoma (NKL), transformed MF to large cell, and PTCL-unspecified (PTCL-U) patients who have failed standard therapy/transplant for their histological confirmed disease or who are not transplant eligible are eligible to participate in this trial
- Karnofsky performance status >= 70
- ANC >= 700 cells/mm^3, unless due to lymphoma involvement of the bone marrow or spleen
- Platelet count >= 50 mm^3, unless due to lymphoma involvement of the bone marrow or spleen
- Hemoglobin >= 8 g/dL, unless due to lymphoma involvement of the bone marrow
- Liver functions (AST, ALT, bilirubin) =< 3 x upper limits of normal (ULN) unless due to lymphoma or due to Gilberts disease
Show all 13Show fewer
- Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 40 mL/min (Cockcroft-Gault)
- LVEF >= 40% 2-D transthoracic ECHO is the preferred method of evaluation; MUGA scan is acceptable if ECHO is not available
- Able to adhere to the study visit schedule and other protocol requirements
- Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Non-pregnant and non-nursing; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
- No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
- Patients with a history of coronary artery disease, congestive heart failure, hypertension, diabetes, or hyperlipidemia must have a MUGA or echocardiography, performed within 2 months of study entry
Who cannot join
- Pregnant or breast feeding females
- Active serious infection requiring treatment within 14 days prior to the start of carfilzomib
- Active hepatitis or uncontrolled HIV
- Unstable angina or myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or EKG evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the start of carfilzomib
- Patients in whom the schedule of oral and IV fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment
Show all 12Show fewer
- Prior malignancies within the past 2 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate specific antigen (PSA) levels
- Significant peripheral neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to the start of carfilzomib
- Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
- Concurrent use of other anti-cancer agents, investigative agents, or treatments
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322
M D Anderson Cancer Center
Houston, Texas, 77030
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma
This phase I trial studies the side effects and best dose of carfilzomib in treating patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD) of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) anaplastic lymphoma receptor tyrosine kinase (ALK)+/ALK-, adult T-cell leukemia/lymphoma (ATLL), natural killer (NK)-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U).
II. To assess the safety and preliminary efficacy of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell leukemia/lymphoma (ATLL), NK-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U).
III. To evaluate nuclear transcription factor kappa-B (NF-kappa B) activation in PTCL tumor tissue and correlate that with response to carfilzomib, a novel proteosome inhibitor, which targets NF-kappa B.
OUTLINE: This is a dose escalation study.
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for year 1, then every 4 months for year 2, then every 6 months for years 3 and 4, and then yearly thereafter.
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma
- Being tested
- carfilzomib
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, T-Cell, Peripheral, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carfilzomibDrug
Also called Kyprolis, PR-171
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (carfilzomib) | Experimental | Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of carfilzomib
MTD of carfilzomib, determined by incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study start21 Jun 2011
- Primary completion1 Apr 2015
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Nasal Type Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Amgen
- Responsible party
- Sponsor
- Investigators
- Julie M Vose, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336920
- Sponsor's protocol ID
- 0518-10-FB
- Other IDs
- NCI-2010-02257, P50CA136411, P30CA036727
- Status last verified
- Sep 2023
- First submitted
- 23 Mar 2011
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Carfilzomib for the Treatment of T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01336920
- Acronym / sponsor ID
- 0518-10-FB
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Amgen
- Study start
- 21 Jun 2011 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of carfilzomib in treating patients with relapsed or refractory T-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To establish the maximum tolerated dose (MTD) of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) anaplastic lymphoma receptor tyrosine kinase (ALK)+/ALK-, adult T-cell leukemia/lymphoma (ATLL), natural killer (NK)-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U).
II. To assess the safety and preliminary efficacy of single agent carfilzomib in patients with relapsed and refractory peripheral T-cell lymphoma (PTCL) including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell leukemia/lymphoma (ATLL), NK-cell lymphoma (NKL), transformed mycosis fungoides (MF) to large cell, and PTCL-unspecified (PTCL-U).
III. To evaluate nuclear transcription factor kappa-B (NF-kappa B) activation in PTCL tumor tissue and correlate that with response to carfilzomib, a novel proteosome inhibitor, which targets NF-kappa B.
OUTLINE: This is a dose escalation study.
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for year 1, then every 4 months for year 2, then every 6 months for years 3 and 4, and then yearly thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (carfilzomib) | Experimental | Drug: carfilzomibPatients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Relapsed and refractory PTCL, including angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) ALK+/ALK-, adult T-cell leukemia/lymphoma (ATLL), NK-cell lymphoma (NKL), transformed MF to large cell, and PTCL-unspecified (PTCL-U) patients who have failed standard therapy/transplant for their histological confirmed disease or who are not transplant eligible are eligible to participate in this trial
- Karnofsky performance status >= 70
- ANC >= 700 cells/mm^3, unless due to lymphoma involvement of the bone marrow or spleen
- Platelet count >= 50 mm^3, unless due to lymphoma involvement of the bone marrow or spleen
- Hemoglobin >= 8 g/dL, unless due to lymphoma involvement of the bone marrow
Key exclusion criteria (12 listed)
- Pregnant or breast feeding females
- Active serious infection requiring treatment within 14 days prior to the start of carfilzomib
- Active hepatitis or uncontrolled HIV
- Unstable angina or myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or EKG evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the start of carfilzomib
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 |
|---|---|---|
| carfilzomibAlso: Kyprolis, PR-171Given IV | Drug | Treatment (carfilzomib) |
Primary outcome
Maximum Tolerated Dose (MTD) of carfilzomib
Time frame: 28 days
MTD of carfilzomib, determined by incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Related trials for Adult Nasal Type Extranodal NK/T-cell Lymphoma
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
Active, not recruitingPhase 1
Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
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.
Julie M Vose principal investigator
University of Nebraska
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carfilzomib in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by University of Nebraska at 3 sites 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 13 inclusion and 12 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: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of carfilzomib (time frame: 28 days). 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 15 Sep 2023.