Peripheral T-Cell LymphomaNCT01841021
Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30
A study testing Brentuximab vedotin in people with Peripheral T-Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- Brentuximab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2016
- Phase
- Interventional
- 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 PTCL expressing CD30 receptor. Following PTCL subtypes will be eligible: Peripheral T - cell lymphoma, not otherwise specified (NOS); Angioimmunoblastic T-cell Lymphoma; Subcutaneous Panniculitis Like T-cell Lymphoma; Hepatosplenic gamma/delta T cell Lymphoma; Extranodal natural killer (NK)T-cell Lymphoma, nasal type; Enteropathy-associated T-cell lymphoma; Adult T-cell Leukemia/lymphoma; T-cell prolymphocytic leukemia; Primary cutaneous gamma-delta T-cell lymphoma; Aggressive NK cell leukemia; Aggressive subtype of T cell Large Granular Lymphocytic (LGL) or transformed LGL leukemia; Epstein Barr Virus(EBV)-positive T-cell lymphoproliferative disorders of childhood; Transformed mycosis fungoides who have progressed following treatment with at least one systemic therapy; Sezary syndrome
- Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
- Patients must have progressive, relapsed or refractory disease after: At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy except for transformed mycosis fungoides as described previously); Relapsed or failed autologous or allogeneic stem cell transplant.
- Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
- Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
- Patients with leukemic form of PTCL who will not have a measurable lesion in two dimensions by CT scan, relapsed or refractory disease must be detected by immunohistochemistry or flow cytometry and molecular clonality studies in bone marrow or peripheral blood.
Show all 18Show fewer
- At least 2 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational products
- Must meet the following criteria within 4 days before the first dose of study drug:
- Neutrophils ≥1,000/ul
- Hemoglobin ≥ 8 g/dL
- Platelets≥ 50.0x10^9 /L
- Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper normal limit (≤ 5 x upper normal limit if documented hepatic involvement with lymphoma)
- Calculated creatinine clearance ≥ 40 mL/min/1.73 m^2 based on Cockcroft and Gault method
- PT or International Normalization Ratio (INR), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x upper limit of normal unless patient is receiving anticoagulants. If patient is on anticoagulation therapy, levels should be within therapeutic range.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Negative pregnancy test for women of childbearing potential
- Recovered (≤ Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Who cannot join
- Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: Myocardial infarction and the New York Heart Association (NYHA) Class III or IV heart failure
- History of another primary malignancy not in clinical remission; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, or localized prostate cancer with prostate-specific antigen (PSA) <1 ng/ml
- Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with previously treated and resolved central nervous system (CNS) lymphoma involvement are permitted.
- Prior administration of Brentuximab vedotin
- Corticosteroid monotherapy for lymphoma within 1 week of the first dose of study drug
- Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment
- Known hypersensitivity to recombinant proteins, or any component contained in the drug formulation
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 Receptor
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment patients might be given.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- Brentuximab vedotin
- Keywords
- Peripheral T-Cell Lymphoma (PTCL), Relapsed, Refractory, CD30 Receptor, Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab vedotinDrug
Also called SGN-35, ADCETRISTM, antibody drug conjugate(ADC), chemotherapy
Brentuximab vedotin will be given by intravenous infusion (into a vein) on Day 1 of every 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin Treatment | Experimental | Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic. Receives: Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.
Measured: Up to 24 months post treatment
Secondary outcomes (6)
Time to Response (TTR)
Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.
Measured: Up to 24 months post treatment
Duration of Response (DOR)
DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).
Measured: Up to 24 months post treatment
Time to Disease Progression (TTP)
Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
Measured: Up to 24 months post treatment
Progression Free Survival (PFS)
Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
Measured: 24 months post treatment
Overall Survival (OS)
Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.
Measured: 24 months post treatment or until study closure
Number of Participants With Study Related Serious Adverse Events (SAEs)
Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.
Measured: Up to 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completionJun 2016
Why it stopped: Slow accrual, loss of sponsor support
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 Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Lubomir Sokol, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841021
- Sponsor's protocol ID
- MCC-17343
- Other IDs
- 35-IST-019
- Status last verified
- Nov 2016
- First submitted
- 24 Apr 2013
- Last updated
- 19 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 Receptor
- ClinicalTrials.gov ID
- NCT01841021
- Acronym / sponsor ID
- MCC-17343
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Peripheral T-Cell Lymphoma (PTCL), Relapsed, Refractory, CD30 Receptor, Large B-Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual, loss of sponsor support
- Enrolment
- 1 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Seagen Inc.
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 19 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment patients might be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin Treatment | Experimental | Drug: Brentuximab vedotinBrentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Confirmed diagnosis of PTCL expressing CD30 receptor. Following PTCL subtypes will be eligible: Peripheral T - cell lymphoma, not otherwise specified (NOS); Angioimmunoblastic T-cell Lymphoma; Subcutaneous Panniculitis Like T-cell Lymphoma; Hepatosplenic gamma/delta T cell Lymphoma; Extranodal natural killer (NK)T-cell Lymphoma, nasal type; Enteropathy-associated T-cell lymphoma; Adult T-cell Leukemia/lymphoma; T-cell prolymphocytic leukemia; Primary cutaneous gamma-delta T-cell lymphoma; Aggressive NK cell leukemia; Aggressive subtype of T cell Large Granular Lymphocytic (LGL) or transformed LGL leukemia; Epstein Barr Virus(EBV)-positive T-cell lymphoproliferative disorders of childhood; Transformed mycosis fungoides who have progressed following treatment with at least one systemic therapy; Sezary syndrome
- Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
- Patients must have progressive, relapsed or refractory disease after: At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy except for transformed mycosis fungoides as described previously); Relapsed or failed autologous or allogeneic stem cell transplant.
- Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
- Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
Key exclusion criteria (8 listed)
- Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: Myocardial infarction and the New York Heart Association (NYHA) Class III or IV heart failure
- History of another primary malignancy not in clinical remission; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, or localized prostate cancer with prostate-specific antigen (PSA) <1 ng/ml
- Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with previously treated and resolved central nervous system (CNS) lymphoma involvement are permitted.
- Prior administration of Brentuximab vedotin
- Corticosteroid monotherapy for lymphoma within 1 week of the first dose of study drug
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 |
|---|---|---|
| Brentuximab vedotinAlso: SGN-35, ADCETRISTM, antibody drug conjugate(ADC), chemotherapyBrentuximab vedotin will be given by intravenous infusion (into a vein) on Day 1 of every 21 day cycle. | Drug | Brentuximab Vedotin Treatment |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 24 months post treatment
ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.
6 secondary outcomes
Time to Response (TTR)
Time frame: Up to 24 months post treatment
Duration of Response (DOR)
Time frame: Up to 24 months post treatment
Time to Disease Progression (TTP)
Time frame: Up to 24 months post treatment
Progression Free Survival (PFS)
Time frame: 24 months post treatment
Overall Survival (OS)
Time frame: 24 months post treatment or until study closure
Number of Participants With Study Related Serious Adverse Events (SAEs)
Time frame: Up to 24 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lubomir Sokol, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brentuximab vedotin in people with Peripheral T-Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 18 inclusion and 8 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 19 Jan 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2017). 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 (ORR) (time frame: Up to 24 months post treatment). 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 19 Jan 2017.