Recurrent Transformed B-Cell Non-Hodgkin LymphomaPhase 2NCT02207062
Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma
A Phase 2 study testing Ibrutinib and Laboratory Biomarker Analysis in people with Recurrent Transformed B-Cell Non-Hodgkin Lymphoma and Refractory Transformed B-Cell Non-Hodgkin Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
This pilot phase II trial studies ibrutinib in treating patients with transformed indolent (a type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a period of improvement (relapsed) or do not respond to treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Ibrutinib and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 1 Nov 2023
- 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
- Patients must have histologically confirmed transformed indolent B-cell non-Hodgkin lymphoma that is relapsed or refractory to at least one line of therapy
- Patients must have a computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis within 28 days of enrollment
- Patients must have measurable disease defined as lesions greater than 1.5 cm that can be accurately measured in two dimensions by CT (preferred), or MRI
- Patients must have a positron emission tomography (PET) scan within 56 days of enrollment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count (ANC) >= 1000/mm^3 or >= 750/mm^3 in the setting of marrow involvement by disease
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- Platelets >= 50,000/mm^3 or >= 30,000/mm^3 in the setting of marrow involvement by disease or splenomegaly due to disease
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Creatinine clearance (Clcr) > 25 mL/min
- Patients must be anticipated to complete 2 cycles of therapy in the opinion of the treating physician
- Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
- Sign (or their legally-acceptable representatives must sign) an informed consent document in accordance with institutional and federal guidelines indicating that they understand the investigational nature of and procedures required for the study, including biomarkers, and are willing to participate in and comply with the guidelines of the study
Who cannot join
- Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection
- Major surgery or a wound that has not fully healed within 4 weeks of initiation of therapy
- Known central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months of screening
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
- Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
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- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- Vaccinated with live, attenuated vaccines within 4 weeks of initiation of therapy
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol sponsor-investigator/lead-sub-investigator
- Patients that previously were treated with ibrutinib for > 7 days
- Previous chemotherapy, immunotherapy, biologically targeted therapy, other investigational agent, or radiation therapy within 3 weeks of initiation of ibrutinib therapy or radio-immunotherapy within 12 weeks of initiation of ibrutinib therapy
- Prior allogeneic transplant with graft-versus-host disease (GVHD) requiring immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Pilot Study of Single-Agent Ibrutinib in Relapsed or Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma
This pilot phase II trial studies ibrutinib in treating patients with transformed indolent (a type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a period of improvement (relapsed) or do not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes (proteins) needed for cell growth.
Read the detailed description
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 5 years.
- Conditions
- Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- Being tested
- Ibrutinib, Laboratory Biomarker Analysis
- Keywords
- Non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called BTK Inhibitor PCI-32765, CRA-032765, PCI-32765
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ibrutinib) | Experimental | Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (Combined Complete Response + Partial Response)
Measured: Up to 5 years
Secondary outcomes (6)
Complete Response Rate
Measured: Up to 5 years
Disease Control Rate
Measured: >12 months
Overall Survival
Measured: Up to 5 years
Progression-free Survival
Progression-free survival will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
Measured: Time from first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years
Response Rate Relative to the Underlying B-cell Histology
Participants with a histology of follicular lymphoma at diagnosis achieving at least a partial response to treatment.
Measured: Up to 5 years
Tolerability of Chronic Ibrutinib Therapy
The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to classify and grade toxicities. Count of participants who stopped ibrutinib due to toxicities.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startOct 2014
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
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 Recurrent Transformed B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Ajay Gopal, University of Washington
- Investigators
- Ajay K. Gopal, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207062
- Sponsor's protocol ID
- 9107
- Other IDs
- NCI-2014-01573, 9107, RG1714041
- Status last verified
- Nov 2024
- First submitted
- 30 Jul 2014
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Single-Agent Ibrutinib in Relapsed or Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02207062
- Acronym / sponsor ID
- 9107
- Conditions
- Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- Keywords
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- Oct 2014
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase II trial studies ibrutinib in treating patients with transformed indolent (a type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a period of improvement (relapsed) or do not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes (proteins) needed for cell growth.
Detailed description
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ibrutinib) | Experimental | Drug: Ibrutinib, Other: Laboratory Biomarker AnalysisPatients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically confirmed transformed indolent B-cell non-Hodgkin lymphoma that is relapsed or refractory to at least one line of therapy
- Patients must have a computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis within 28 days of enrollment
- Patients must have measurable disease defined as lesions greater than 1.5 cm that can be accurately measured in two dimensions by CT (preferred), or MRI
- Patients must have a positron emission tomography (PET) scan within 56 days of enrollment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Key exclusion criteria (13 listed)
- Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection
- Major surgery or a wound that has not fully healed within 4 weeks of initiation of therapy
- Known central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months of screening
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., 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 |
|---|---|---|
| IbrutinibAlso: BTK Inhibitor PCI-32765, CRA-032765, PCI-32765Given PO | Drug | Treatment (ibrutinib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ibrutinib) |
Primary outcome
Overall Response Rate (Combined Complete Response + Partial Response)
Time frame: Up to 5 years
6 secondary outcomes
Complete Response Rate
Time frame: Up to 5 years
Disease Control Rate
Time frame: >12 months
Overall Survival
Time frame: Up to 5 years
Progression-free Survival
Time frame: Time from first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years
Response Rate Relative to the Underlying B-cell Histology
Time frame: Up to 5 years
Tolerability of Chronic Ibrutinib Therapy
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 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.
Ajay K. Gopal principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Ibrutinib and Laboratory Biomarker Analysis in people with Recurrent Transformed B-Cell Non-Hodgkin Lymphoma and Refractory Transformed B-Cell Non-Hodgkin Lymphoma, run by University of Washington 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 14 inclusion and 13 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 7 Jan 2025. 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 7 Jan 2025). 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 (Combined Complete Response + Partial Response) (time frame: Up to 5 years). 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 7 Jan 2025.