Diffuse Large B-Cell LymphomaPhase 2NCT02692248
Ibrutinib in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non-candidates to ASCT
A Phase 2 study testing Ibrutinib, Rituximab and Gemcitabine in people with Diffuse Large B-Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 17 sites in Spain.
Trial summary
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Ibrutinib, Rituximab and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 17 sitesSpain
- Study dates
- 7 Apr 2016to 19 Jan 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with confirmed histologically diagnosis of diffuse large B-cell lymphoma.
- Subjects must be 18 years of age or older.
- Non-germinal center B-cell-like (GCB) subtype according to Hans algorithm (local laboratories).
- -A central review will be performed for confirmation of the germinal center B-cell-like, however even when negative results are reported, the patient will still be part of the study if clinical benefit after cycle 4 is documented (stable disease, partial response and complete response).
- Relapsed or refractory disease after:
- at least 1 prior line of therapy that includes rituximab in combination with chemotherapy, or,
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- after previous ASCT, or,
- after reduced intensity conditioning allogeneic transplant, unless patient is receiving immunosuppressive drugs or active graft versus host disease is present at study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Baseline FDG-PET scan demonstrating positive lesions (Deauville 4 or 5) compatible with CT defined anatomical tumor sites.
- Hematology values must be within the following limits:
- absolute neutrophil count (ANC) ≥1000/μL independent of growth factor support.
- platelets ≥100000/μL or ≥50000/μL if bone marrow involvement independent of transfusion support in either situation.
- Biochemical values within the following limits:
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 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.
- serum creatinine ≤2 x ULN or estimated creatinine clearance (CCr) ≥30 mL/min.
- Women of childbearing potential and men who are sexually active must be 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 and 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 study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) 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 indicating that they understand the purpose of and procedures required for the study and are willing and able to participate in the study.
Who cannot join
- Prior malignancy other than DLBCL, with the exception of adequately treated basal cell or squamous cell skin tumor, in situ cervical cancer, or other tumor from which the patient has been disease free for at least 2 years or which will not limit survival to < 2 years (Note: these cases must be discussed with the Principal Investigator).
- Candidates to autologous stem cell transplant.
- Young patients with more than a previous line and refractory could be considered as not suitable for autologous stem cell transplant and, therefore, are eligible for this study.
- Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety,interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk.
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis,symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
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- Treatment with any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 3 weeks before first dose of study drug.
- Prior treatment with ibrutinib or other BTK inhibitors.
- Central nervous system (CNS) involvement by lymphoma.
- History of stroke or intracranial hemorrhage within 6 months prior to randomization.
- Requires anticoagulation with warfarin or equivalent Vitamin K antagonists.
- Requires treatment with strong CYP3A inhibitors.
- Grade ≥2 toxicity (other than alopecia) related to prior anticancer therapy including radiation.
- Known history of human immunodeficiency virus (HIV), active hepatitis C virus (HCV) (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring IV antibiotics. Subjects with PCR-negative HBV are permitted in the study.
- Major surgery within 4 weeks before first dose of study drug.
- Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
- Pregnancy or lactation
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario Donostia
Donostia / San Sebastian, Guipúzcoa, 20080
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Especialidades
Jerez de la Frontera, Cádiz, 11407
Hospital Universitario Infanta Leonor
Madrid, 28031
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General Universitario Morales Meseguer
Murcia, 30008
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clínic Universitari de València
Valencia, 46010
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra
About this study
Official title: Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone Followed by Ibrutinib Maintenance in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non Candidates to ASCT
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
Read the detailed description
The use of highly effective rituximab-containing therapy for treating diffuse large B-cell lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In addition, patients with advanced age or significant comorbidities, who are consequently not candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective studies investigating new salvage regimens are essential.
The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is a potent killer of ABC DLBCL cell lines in vitro and in xenografts.
It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II trial, to investigate the safety and efficacy of the combination of ibrutinib with rituximab, gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as salvage therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to stem cell transplant.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Ibrutinib, Rituximab, Gemcitabine, Oxaliplatin, Dexamethasone
- 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
Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
RituximabDrug
Rituximab 375 mg/m2 IV day 1 during 4 cycles.
GemcitabineDrug
Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
OxaliplatinDrug
Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
DexamethasoneDrug
Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib -R-GEMOX-Dexa | Experimental | Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/m2 IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/m2 on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. Receives: Drug: Ibrutinib; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (OR) Rate
Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
Measured: Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Secondary outcomes (6)
CR Rate During Induction and Maintenance Phases.
Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months
Measured: Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Response Duration
Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease.
Measured: Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months.
Progression Free Survival
Progression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow.
Measured: Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months
Event-free Survival
Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0
Measured: 2 years and 4 months.
Overall Survival
Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time.
Measured: 2 years
Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone
Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC
Measured: 2 years and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start7 Apr 2016
- Primary completion8 Nov 2018
- Study completion19 Jan 2021
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 Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Responsible party
- Sponsor
- Investigators
- Dolores Caballero, MD, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692248
- Sponsor's protocol ID
- IBDCL-GELTAMO-2015
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2016
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone Followed by Ibrutinib Maintenance in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non Candidates to ASCT
- ClinicalTrials.gov ID
- NCT02692248
- Acronym / sponsor ID
- IBDCL-GELTAMO-2015
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
Detailed description
The use of highly effective rituximab-containing therapy for treating diffuse large B-cell lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In addition, patients with advanced age or significant comorbidities, who are consequently not candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective studies investigating new salvage regimens are essential.
The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is a potent killer of ABC DLBCL cell lines in vitro and in xenografts.
It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II trial, to investigate the safety and efficacy of the combination of ibrutinib with rituximab, gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as salvage therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib -R-GEMOX-Dexa | Experimental | Drug: Ibrutinib, Drug: Rituximab, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: DexamethasoneSubjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase: * Rituximab 375 mg/m2 IV day 1 * Gemcitabine 1000 mg/m2 IV on day 1 or 2 (at investigator discretion). * Oxaliplatine 100 mg/m2 on day 1 or 2 (after Gemcitabine administration); * Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3. * Ibrutinib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects with confirmed histologically diagnosis of diffuse large B-cell lymphoma.
- Subjects must be 18 years of age or older.
- Non-germinal center B-cell-like (GCB) subtype according to Hans algorithm (local laboratories).
- -A central review will be performed for confirmation of the germinal center B-cell-like, however even when negative results are reported, the patient will still be part of the study if clinical benefit after cycle 4 is documented (stable disease, partial response and complete response).
- Relapsed or refractory disease after:
Key exclusion criteria (17 listed)
- Prior malignancy other than DLBCL, with the exception of adequately treated basal cell or squamous cell skin tumor, in situ cervical cancer, or other tumor from which the patient has been disease free for at least 2 years or which will not limit survival to < 2 years (Note: these cases must be discussed with the Principal Investigator).
- Candidates to autologous stem cell transplant.
- Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety,interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk.
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis,symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
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 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years). | Drug | Ibrutinib -R-GEMOX-Dexa |
| RituximabRituximab 375 mg/m2 IV day 1 during 4 cycles. | Drug | Ibrutinib -R-GEMOX-Dexa |
| GemcitabineGemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days. | Drug | Ibrutinib -R-GEMOX-Dexa |
| OxaliplatinOxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days. | Drug | Ibrutinib -R-GEMOX-Dexa |
| DexamethasoneDexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days. | Drug | Ibrutinib -R-GEMOX-Dexa |
Primary outcome
Overall Response (OR) Rate
Time frame: Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
6 secondary outcomes
CR Rate During Induction and Maintenance Phases.
Time frame: Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Response Duration
Time frame: Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months.
Progression Free Survival
Time frame: Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months
Event-free Survival
Time frame: 2 years and 4 months.
Overall Survival
Time frame: 2 years
Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone
Time frame: 2 years and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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.
Dolores Caballero, MD study chair
University of Salamanca
17 sites 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, Rituximab and Gemcitabine in people with Diffuse Large B-Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 17 sites in Spain.
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 17 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. 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 10 Oct 2024). 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 (OR) Rate (time frame: Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months). 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 10 Oct 2024.