Recurrent Diffuse Large B-Cell LymphomaPhase 2NCT02874404
TGR-1202 and Ibrutinib in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Ibrutinib, Laboratory Biomarker Analysis and PI3K-delta Inhibitor TGR-1202 in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement or does not respond to treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- Ibrutinib, Laboratory Biomarker Analysis and PI3K-delta Inhibitor TGR-1202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2016to 1 Jul 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) or transformed DLBCL
- Hematoxylin and eosin (H\&E) stain and immunohistochemistry (IHC) slides or a representative formalin-fixed, paraffin-embedded (FFPE) tissue block along with the pathology report from initial diagnosis, (as well as, an optional 8 unstained slides of 4 micron thickness to store for future IHC and DNA specified research use), should be sent to be reviewed, and the diagnosis confirmed by University of Nebraska Medical Center (UNMC) (retrospective diagnostic review: treatment may commence prior to the UNMC review); please NOTE: the diagnostic H\&E slide and IHC slides will be returned after review; only the optional 8 unstained slides will be retained and stored for future unspecified research use
- Patients with relapsed or refractory DLBCL that has relapsed post-transplant or that has been determined to be ineligible or unsuitable for transplant; patients must have to have received at least one prior systemic therapy
- Patients must have measurable (>= 1.5 cm) or evaluable disease; baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging; measurable disease must have at least one objective measurable disease parameter; a clearly defined, bi-dimensionally measurable defect or mass measuring at least 1.5 cm in diameter on a CT scan will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy; skin lesions can be used as measurable disease provided bi-dimensional measurements are possible
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- By automated or manual review, whichever is greatest
Show all 20Show fewer
- Platelets >= 100 x 10^9/L:
- Unless due to bone marrow infiltration then eligible if platelets > 50 x 10^9/L)
- Total bilirubin =< 1.5 x upper normal limit if documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history of Gilbert's disease
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) if no liver involvement or =< 5 x the ULN if documented liver involvement
- Creatinine =< 2.0 mg/dL OR calculated creatinine clearance >= 50 mL/min (as calculated by the Cockcroft-Gault method)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or expected survival duration of > 2 months
- Ability to swallow and retain oral medication
- Women must not be pregnant or breast-feeding
- All female patients of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to treatment to rule out pregnancy
- Pregnancy testing is not required for post-menopausal or surgically sterilized women
- Male and female patients of reproductive potential must agree to follow accepted birth control measures throughout the study period and for 30 days after the last dose of either study drug for females and 3 months after the last dose of study drug for males
- Patient must be able to adhere to the study visit schedule and other protocol requirements
- Patient must be aware of the neoplastic nature of his/her disease and willingly sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in 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
Who cannot join
- Currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, and surgery and/or tumor embolization) or any investigational drug within 7 days of cycle 1/day 1, 14 days of cycle 1/day 1 for limited palliative radiation, and/or five half-live of an oral therapy
- Corticosteroid therapy started at least 7 days prior to initiation of treatment (prednisone =< 10 mg daily or equivalent) is allowed as clinically warranted); topical or inhaled corticosteroids are permitted
- Major surgery or a wound that has not fully healed within 4 weeks of enrollment
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
- Vaccinated with live, attenuated vaccines within 4 weeks of enrollment
Show all 22Show fewer
- Autologous hematologic stem cell transplant within 3 months of study entry
- Allogeneic hematologic stem cell transplant within 12 months of study entry
- Active graft versus-host disease and must not be on immunosuppression
- Wide field radiotherapy within 28 days of cycle 1/day 1 or active side effects of such therapy
- Active hepatitis B (hepatitis B virus [HBV]) or C (hepatitis C virus [HCV]) infection (negative serology required excluding those with are seropositive due to prior vaccination) and/or known history of human immunodeficiency virus (HIV)
- Primary central nervous system involvement only
- Require treatment with strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors
- Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extra-hepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension
- Any life-threatening illness, severe and/or uncontrolled medical condition, or organ system dysfunction, laboratory abnormality, psychiatric illness or other condition which, in the Investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, put the study outcomes at undue risk or affect their participation in the study such as
- Symptomatic, or history of documented congestive heart failure New York Heart Association (NYHA) functional classification III-IV (NYHA)
- Corrected QT interval using Fridericia's formula (QTcF) > 470 msec (unless related to pacemaker) on echocardiogram (EKG) within 7 days of initiation of treatment
- Angina not well-controlled by medication
- Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac or vascular stenting within 6 months prior to enrollment
- Prior malignancies within the past 1 year 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
- Women who are pregnant or breastfeeding; women who agree to stop breastfeeding would be eligible
- Known hypersensitivity to either study drug (TGR-1202 or ibrutinib)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Single-Center Phase IIa Study Evaluating the Safety and Tolerability of TGR-1202 and Ibrutinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Trial of the Lymphoma Precision Medicine Laboratory
This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of PI3K delta inhibitor TGR-1202 (TGR-1202) and ibrutinib in relapsed and refractory (rel/ref) diffuse large B-cell lymphoma (DLBCL).
SECONDARY OBJECTIVES:
- To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR).
II. To determine the event-free survival (EFS), time to response (TTR), and duration of response (DOR) in patients with rel/ref DLBCL.
TERTIARY OBJECTIVES:
- To evaluate molecular profiling of patient samples (optional lymph node biopsies) obtained at days 0 (pre-treatment; core biopsy), day 8 (fine needle aspiration) and end of treatment (progressive disease or end of study treatment-1 year; core biopsy).
II. To evaluate the baseline characteristics and dynamic shifts in mutational Landscape, transcriptional signatures and intracellular signaling cascades in primary tumor cells.
III. To define the mutational status of 384 genes that mutated in DLBCL, including cluster of differentiation (CD)79B, caspase recruitment domain family member 11 (CARD11), and myeloid differentiation primary response 88 (MYD88).
IV. To evaluate signatures of B-cell receptor signaling and the back-up pathway of oxidative phosphorylation.
- To measure the basal and induced level of activation of components within parallel signaling pathways downstream of the B-cell receptor.
VI. To monitor changes in T-cell characteristics in response to exposure to TGR-1202 and ibrutinib.
VII. To perform quantitative response evaluation by peripheral blood cell-free deoxyribonucleic acid (DNA) sequencing at enrollment, day 8, 1 month, at every response assessment time point compared to standard radiographic response evaluation by positron emission tomography (PET)/ computed tomography (CT) or CT and end of treatment (progressive disease or end of study treatment-1 year).
VIII. To evaluate the genetic profiling for drug resistance mutations. IX. To evaluate DLBCL subtype analysis by immunohistochemistry compared to Nanostring assessment.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP A: Patients receive PI3K delta inhibitor TGR-1202 orally (PO) once daily (QD) on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive ibrutinib PO QD on days 1-28 and PI3K delta inhibitor TGR-1202 PO QD and days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
GROUP C: Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and after 1 year.
- Being tested
- Ibrutinib, Laboratory Biomarker Analysis, PI3K-delta Inhibitor TGR-1202
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
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, Imbruvica, PCI-32765
Given PO
Laboratory Biomarker AnalysisOther
Correlative markers
PI3K-delta Inhibitor TGR-1202Drug
Also called RP5264, TGR-1202
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group A (PI3K delta inhibitor TGR-1202, ibrutinib) | Experimental | Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Drug: PI3K-delta Inhibitor TGR-1202 |
| Group B (Ibrutinib, PI3K delta inhibitor TGR-1202) | Experimental | Patients receive ibrutinib PO QD on days 1-28 and PI3K delta inhibitor TGR-1202 PO QD and days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Drug: PI3K-delta Inhibitor TGR-1202 |
| Group C (PI3K delta inhibitor TGR-1202, ibrutinib) | Experimental | Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Drug: PI3K-delta Inhibitor TGR-1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events
Notable serious or recurrent adverse events (SAEs or AEs) of interest occurring across all cycles regardless of attribution assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: Up to 112 days (course 4)
Secondary outcomes (2)
Overall Response Rate (ORR)
ORR is defined as number of patients achieving a best response of complete response or partial response at any disease assessment time point. Response is based on PET/CT (Deauville 3 or less) or CT alone if CR is achieved by PET/CT. Response criteria, modified from the Lugano response criteria. DLBCL is considered FDG avid.
Complete response:
Complete disappearance of all detectable clinical evidence of disease and definitely disease-related symptoms if present before therapy.
Criteria for Partial Response (PR):
Regression of measurable disease and no new sites
Measured: Up to 4 years
Estimated Progression-free Survival (PFS) at 6 Months
PFS is defined as the time between study registration and documented progression or death if no progression was observed.
Measured: Time between study registration and documented progression or death if no progression was observed, assessed up to 4 years (6 Month estimate shown)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start7 Oct 2016
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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 Diffuse Large B-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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew A Lunning, DO, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874404
- Sponsor's protocol ID
- 0345-16-FB
- Other IDs
- NCI-2016-01082, P30CA036727
- Status last verified
- Sep 2023
- First submitted
- 17 Aug 2016
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Phase IIa Study Evaluating the Safety and Tolerability of TGR-1202 and Ibrutinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Trial of the Lymphoma Precision Medicine Laboratory
- ClinicalTrials.gov ID
- NCT02874404
- Acronym / sponsor ID
- 0345-16-FB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of PI3K delta inhibitor TGR-1202 (TGR-1202) and ibrutinib in relapsed and refractory (rel/ref) diffuse large B-cell lymphoma (DLBCL).
SECONDARY OBJECTIVES:
- To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR).
II. To determine the event-free survival (EFS), time to response (TTR), and duration of response (DOR) in patients with rel/ref DLBCL.
TERTIARY OBJECTIVES:
- To evaluate molecular profiling of patient samples (optional lymph node biopsies) obtained at days 0 (pre-treatment; core biopsy), day 8 (fine needle aspiration) and end of treatment (progressive disease or end of study treatment-1 year; core biopsy).
II. To evaluate the baseline characteristics and dynamic shifts in mutational Landscape, transcriptional signatures and intracellular signaling cascades in primary tumor cells.
III. To define the mutational status of 384 genes that mutated in DLBCL, including cluster of differentiation (CD)79B, caspase recruitment domain family member 11 (CARD11), and myeloid differentiation primary response 88 (MYD88).
IV. To evaluate signatures of B-cell receptor signaling and the back-up pathway of oxidative phosphorylation.
- To measure the basal and induced level of activation of components within parallel signaling pathways downstream of the B-cell receptor.
VI. To monitor changes in T-cell characteristics in response to exposure to TGR-1202 and ibrutinib.
VII. To perform quantitative response evaluation by peripheral blood cell-free deoxyribonucleic acid (DNA) sequencing at enrollment, day 8, 1 month, at every response assessment time point compared to standard radiographic response evaluation by positron emission tomography (PET)/ computed tomography (CT) or CT and end of treatment (progressive disease or end of study treatment-1 year).
VIII. To evaluate the genetic profiling for drug resistance mutations. IX. To evaluate DLBCL subtype analysis by immunohistochemistry compared to Nanostring assessment.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP A: Patients receive PI3K delta inhibitor TGR-1202 orally (PO) once daily (QD) on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive ibrutinib PO QD on days 1-28 and PI3K delta inhibitor TGR-1202 PO QD and days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
GROUP C: Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and after 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (PI3K delta inhibitor TGR-1202, ibrutinib) | Experimental | Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Drug: PI3K-delta Inhibitor TGR-1202Patients receive PI3K delta inhibitor TGR-1202 PO QD on days 1-28 and ibrutinib PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
| Group B (Ibrutinib, PI3K delta inhibitor TGR-1202) | Experimental | Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Drug: PI3K-delta Inhibitor TGR-1202Patients receive ibrutinib PO QD on days 1-28 and PI3K delta inhibitor TGR-1202 PO QD and days 9-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
| Group C (PI3K delta inhibitor TGR-1202, ibrutinib) | Experimental | Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Drug: PI3K-delta Inhibitor TGR-1202Patients then receive PI3K delta inhibitor TGR-1202 PO QD and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 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 (20 listed)
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) or transformed DLBCL
- Hematoxylin and eosin (H\&E) stain and immunohistochemistry (IHC) slides or a representative formalin-fixed, paraffin-embedded (FFPE) tissue block along with the pathology report from initial diagnosis, (as well as, an optional 8 unstained slides of 4 micron thickness to store for future IHC and DNA specified research use), should be sent to be reviewed, and the diagnosis confirmed by University of Nebraska Medical Center (UNMC) (retrospective diagnostic review: treatment may commence prior to the UNMC review); please NOTE: the diagnostic H\&E slide and IHC slides will be returned after review; only the optional 8 unstained slides will be retained and stored for future unspecified research use
- Patients with relapsed or refractory DLBCL that has relapsed post-transplant or that has been determined to be ineligible or unsuitable for transplant; patients must have to have received at least one prior systemic therapy
- Patients must have measurable (>= 1.5 cm) or evaluable disease; baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging; measurable disease must have at least one objective measurable disease parameter; a clearly defined, bi-dimensionally measurable defect or mass measuring at least 1.5 cm in diameter on a CT scan will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy; skin lesions can be used as measurable disease provided bi-dimensional measurements are possible
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Key exclusion criteria (22 listed)
- Currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, and surgery and/or tumor embolization) or any investigational drug within 7 days of cycle 1/day 1, 14 days of cycle 1/day 1 for limited palliative radiation, and/or five half-live of an oral therapy
- Major surgery or a wound that has not fully healed within 4 weeks of enrollment
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
- Vaccinated with live, attenuated vaccines within 4 weeks of 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 |
|---|---|---|
| IbrutinibAlso: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765Given PO | Drug | Group A (PI3K delta inhibitor TGR-1202, ibrutinib), Group B (Ibrutinib, PI3K delta inhibitor TGR-1202), Group C (PI3K delta inhibitor TGR-1202, ibrutinib) |
| Laboratory Biomarker AnalysisCorrelative markers | Other | Group A (PI3K delta inhibitor TGR-1202, ibrutinib), Group B (Ibrutinib, PI3K delta inhibitor TGR-1202), Group C (PI3K delta inhibitor TGR-1202, ibrutinib) |
| PI3K-delta Inhibitor TGR-1202Also: RP5264, TGR-1202Given PO | Drug | Group A (PI3K delta inhibitor TGR-1202, ibrutinib), Group B (Ibrutinib, PI3K delta inhibitor TGR-1202), Group C (PI3K delta inhibitor TGR-1202, ibrutinib) |
Primary outcome
Participants With Adverse Events
Time frame: Up to 112 days (course 4)
Notable serious or recurrent adverse events (SAEs or AEs) of interest occurring across all cycles regardless of attribution assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 4 years
Estimated Progression-free Survival (PFS) at 6 Months
Time frame: Time between study registration and documented progression or death if no progression was observed, assessed up to 4 years (6 Month estimate shown)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matthew A Lunning, DO principal investigator
University of Nebraska
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, Laboratory Biomarker Analysis and PI3K-delta Inhibitor TGR-1202 in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, run by University of Nebraska 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 20 inclusion and 22 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 5 Oct 2023. 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 26 Feb 2020). 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?
Participants With Adverse Events (time frame: Up to 112 days (course 4)). 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 5 Oct 2023.