T-cell LymphomaPhase 1NCT02309580
Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
A Phase 1 study testing Ibrutinib in people with T-cell Lymphoma and Relapsed and Refractory T-cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphoma, Relapsed and Refractory T-cell Lymphoma
- What is being tested?
- Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 8 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology confirmed relapsed or refractory T-cell lymphoma (PTCL and stage >IBCTCL) at treating institution
- Relapse or progression after at least 1 systemic therapy
- Age ≥18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study. If there is progression of disease on that therapy and all adverse effects have resolved to Grade 1 or baseline, in which case 2 weeks is acceptable
- Previous radiation, hormonal therapy, and surgery must have been discontinued at least 2 weeks prior to treatment in this study and adverse effects must have resolved. Lymph node or other diagnostic biopsy within 2 weeks is not considered exclusionary
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- Systemic corticosteroids are permissible in the following circumstances:
- Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (≤ 7 days) must have been discontinued at least 7 days prior to study treatment.
- Ongoing administration of a stable dose of corticosteroid therapy (previously received for ≥ 30 days) is permissible provided there is evidence of measurable disease and there will be no increase in steroid dose during the clinical trial
- ECOG performance status of ≤ 2 at study entry
- Patients who have undergone autologous stem cell transplant > 6 months prior are eligible
- Patients who have undergone allogeneic stem cell transplant > 12 months, without active graft-versus-host-disease, and not on immunosuppression for prevention of graft-versus-host disease are eligible
- Laboratory test results within these range:
- Adequate hematologic function with screening laboratory assessment defined as:
- Absolute neutrophil count >1,000 cells/mm3 (1.0 x 10^9/L)
- Platelet count >75,000 cells/mm3 (75 x 10^9/L), if thrombocytopenia is due to bone marrow involvement platelet count must be ≥ 50,000 cells/mm3
- Hemoglobin >8.0 g/dL
- Adequate hepatic and renal function with screening laboratory assessment defined as:
- Serum aspartate transaminase (AST) or alanine transaminase (ALT)
- ≤2.5 x upper limit of normal (ULN)
- Creatinine <2.0 x ULN or Estimated Glomerular Filtration Rate GFR [Cockcroft-Gault] > 30 mL/min.
- Bilirubin <1.5 x ULN [unless bilirubin rise is due to Gilbert's syndrome (as defined by >80% unconjugated hyperbilirubinemia) or of nonhepatic origin]
- Females of childbearing potential (FCBP)† must have a negative serum pregnancy test and agree to use appropriate methods of birth control
Who cannot join
- Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded. For eligibility on this trial, allogeneic stem cell transplantation is not considered a standard curative option
- Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drug
- Recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug
- Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia
- Treatment with warfarin or other Vitamin K antagonists (eg, phenprocoumon)
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk
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- Unwilling or unable to participate in all required study evaluations and procedures.
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF)
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
- Unable to swallow capsules, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- Pregnant females (Lactating females must agree not to breast feed while taking ibrutinib
- Prior use of ibrutinib
- Known seropositive and requiring anti-viral therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by PCR.
- Active concurrent malignancy requiring active therapy
- Known central nervous system or meningeal involvement (in the absence of symptoms investigation into central nervous system involvement is not required)
- Patients who require treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University
Columbus, Ohio, 43210
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Multicenter Phase I Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see what effect the drug has on the patient and the disease.
- Being tested
- Ibrutinib
- Keywords
- Ibrutinib, 14-227
- Medical subject headings
- Lymphoma, T-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Ibrutinib will be administered once daily continuously until disease progression (confirmed by two assessments for CTCL patients only) or intolerance. The dose levels for the Phase 1 portion of the study. Either 560 mg (4 X 140 mg capsules) or 840 mg (6 X 140 mg capsules) doses will be administered. After the recommended expansion dose is established, an expansion cohort of 12 additional patients will be treated at the recommended expansion dose to further characterize the safety at that dose and to further assess preliminary efficacy
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Experimental | This will be a standard dose-escalation study to determine the MTD of ibrutinib in relapsed/refractory PTCL or CTCL. At each dose 6 patients with TCL (PTCL or CTCL) will be enrolled. The first 6 patients will be enrolled at dose level 1. Dose escalation to the next dose level will proceed after DLT assessment of all 6 patients at the end of cycle 1 (28-days). Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated does
evaluate the safety and toxicities of ibrutinib in patients with relapsed/refractory Tcell lymphoma (PTCL and CTCL) as defined by CTCAE version 4.
Measured: 1 year
Secondary outcomes (1)
overall response rate (ORR)
Response and progression of disease will be evaluated in this study using the revised response criteria for malignant lymphoma with incorporation of PET/CT.33 Response in subjects with CTCL will be assessed using a specific skin scoring system with mSWAT and incorporation of measurements of extracutaneous disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Pharmacyclics LLC., Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Anita Kumar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309580
- Sponsor's protocol ID
- 14-227
- Status last verified
- May 2023
- First submitted
- 3 Dec 2014
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kumar A, Vardhana S, Moskowitz AJ, Porcu P, Dogan A, Dubovsky JA, Matasar MJ, Zhang Z, Younes A, Horwitz SM. Pilot trial of ibrutinib in patients with relapsed or refractory T-cell lymphoma. Blood Adv. 2018 Apr 24;2(8):871-876. doi: 10.1182/bloodadvances.2017011916.
PubMed 29669753
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02309580
- Acronym / sponsor ID
- 14-227
- Keywords
- Ibrutinib, 14-227
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Ohio State University, Pharmacyclics LLC., Janssen Biotech, Inc.
- Study start
- Jan 2015
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 5 Dec 2014 (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 is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see what effect the drug has on the patient and the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | Experimental | Drug: IbrutinibThis will be a standard dose-escalation study to determine the MTD of ibrutinib in relapsed/refractory PTCL or CTCL. At each dose 6 patients with TCL (PTCL or CTCL) will be enrolled. The first 6 patients will be enrolled at dose level 1. Dose escalation to the next dose level will proceed after DLT assessment of all 6 patients at the end of cycle 1 (28-days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pathology confirmed relapsed or refractory T-cell lymphoma (PTCL and stage >IBCTCL) at treating institution
- Relapse or progression after at least 1 systemic therapy
- Age ≥18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study. If there is progression of disease on that therapy and all adverse effects have resolved to Grade 1 or baseline, in which case 2 weeks is acceptable
Key exclusion criteria (16 listed)
- Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded. For eligibility on this trial, allogeneic stem cell transplantation is not considered a standard curative option
- Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.) within 28 days of the first dose of study drug
- Recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug
- Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia
- Treatment with warfarin or other Vitamin K antagonists (eg, phenprocoumon)
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 |
|---|---|---|
| IbrutinibIbrutinib will be administered once daily continuously until disease progression (confirmed by two assessments for CTCL patients only) or intolerance. The dose levels for the Phase 1 portion of the study. Either 560 mg (4 X 140 mg capsules) or 840 mg (6 X 140 mg capsules) doses will be administered. After the recommended expansion dose is established, an expansion cohort of 12 additional patients will be treated at the recommended expansion dose to further characterize the safety at that dose and to further assess preliminary efficacy | Drug | Ibrutinib |
Primary outcome
Maximum tolerated does
Time frame: 1 year
evaluate the safety and toxicities of ibrutinib in patients with relapsed/refractory Tcell lymphoma (PTCL and CTCL) as defined by CTCAE version 4.
1 secondary outcome
overall response rate (ORR)
Time frame: 1 year
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 9 May 2023.
- Derived from this study: PubMed 29669753Kumar A, Vardhana S, Moskowitz AJ, Porcu P, Dogan A, Dubovsky JA, Matasar MJ, Zhang Z, Younes A, Horwitz SM. Pilot trial of ibrutinib in patients with relapsed or refractory T-cell lymphoma. Blood Adv. 2018 Apr 24;2(8):871-876. doi: 10.1182/bloodadvances.2017011916.
- Memorial Sloan Kettering Cancer CenterLink 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.
Anita Kumar, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 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 Ibrutinib in people with T-cell Lymphoma and Relapsed and Refractory T-cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 2 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 23 inclusion and 16 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 does (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309580, which also lists 1 linked publication.
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 9 May 2023.