Diffuse Large B Cell LymphomaPhase 1/2ImbruVeRCHOPNCT03129828
Ibrutinib, Bortezomib and Rituximab-CHOP for the Treatment of Elderly Patients With CD20+ DLBCL, IPI ≥ 2
A Phase 1/2 study testing Ibrutinib and Bortezomib + R-CHOP in people with Diffuse Large B Cell Lymphoma, run by Prof. Dr. Clemens Schmitt at 1 site in Germany.
Trial summary
The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective, open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate outcome with clinical, molecular and… Read more about this study
- Who is it for?
- Ages 61 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Ibrutinib and Bortezomib + R-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2017to 12 Nov 2024
- Phase
- Phase 1/2
- 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 61 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent indicating that they understand the purpose of and procedures required for the study, including biomarkers and are willing to participate in the study
- Age ≥ 61 years and ≤ 80 years
- CD20-positive diffuse large B-cell lymphoma (DLBCL); including T-cell-rich large B-cell lymphoma, anaplastic large B-cell lymphoma, plasmablastic lymphoma; follicular lymphoma grade 3b or primary transformed follicular lymphoma at initial diagnosis or highgrade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements or high-grade B-cell lymphoma NOS
- Lymphoma biopsy native, fresh-frozen for genome-wide transcriptome array or RNA-Seq analyses (gene expression profiling [GEP]) for molecular subtype diagnosis
- Willingness to consent to a re-biopsy in C1/day d2, and - in case of a residual lesion by interim CT - in C3/d2 if it can be obtained without inadequate risk
- Unfavorable risk profile according to the IPI score (IPI ≥ 2)
Show all 15Show fewer
- Performance status (ECOG) 0-2
- Bi-dimensionally measurable disease (measurable by CT scan or MRI)
- Cardiac ejection fraction ≥ 50 % without clinically significant abnormalities
- Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,00/μL independent of growth factor support and platelet count ≥ 100,000/μL or ≥ 50,000/μL if bone marrow involvement independent of transfusion support in either situation
- Adequate renal function as documented by serum creatinine level < 2 x ULN or estimated GFR ≥ 40 ml/min/1,73m²
- Adequate hepatic function (total bilirubin ≤ 1,5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 3 x ULN)
- Life expectancy > 6 months
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study.
- 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 month after the last dose of study drug.
Who cannot join
- Unable to sign informed consent
- Secondary transformed B-NHL or types of NHL other than DLBCL and its subtypes according to WHO classification
- Prior therapy for DLBCL
- Known central nervous system lymphoma
- CNS involvement by lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks prior to study entrance) in case of clinical suspicion of CNS involvement by lymphoma
- Major surgery within 4 weeks of study entrance
Show all 25Show fewer
- History of stroke or intracranial hemorrhage within 6 months prior to study entrance
- Anticoagulation with Warfarin or equivalent vitamin K antagonists (e.g, Phenprocoumon)
- 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 or 4 cardiac disease as defined by NYHA
- treatment with strong CYP3A inhibitors
- Known history of human immunodeficiency virus HIV or active Hepatitis C virus or active Hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous iv antibiotics
- Vaccination with live, attenuated vaccines within 3 weeks of study entrance
- History of solid organ transplantation
- Pregnant or nursing females
- Prior malignancy (except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical cancer in situ, or any other cancer for which the patient has been in remission for at least 5 years)
- Known hypersensitivity or contraindication to any of the study drugs, its ingredients or recombinant human antibodies and contrast agents
- Pre-existing polyneuropathy of any kind > grade I
- Severe chronic obstructive pulmonary disease with hypoxemia
- Current or recent (within the last 30 days prior to enrollment) treatment with another investigational drug or participation in another clinical trial
- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigators opinion, could compromise the subjects safety, interfere with the absorption or metabolism of ibrutinib capsules or put the study outcomes at undue risk
- Any co-existing medical or psychological condition that would compromise the ability to give informed consent
- Subjects who are legally detained in an official institution
- Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be exclude from the trial
- Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin, Hematology, Oncology and Tumor Immunology, Campus Virchow Klinikum
Berlin, 13353
About this study
Official title: Ibrutinib (Imbruvica®), Bortezomib (Velcade®) s.c., Rituximab, CHOP for the Treatment of Elderly Patients (Age 61-80 Years) With CD20+ Diffuse Large B-cell Lymphoma, IPI ≥ 2
The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective, open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate outcome with clinical, molecular and imaging-guided response parameters. The protocol includes a safety run-in phase, i.e. the phase I part of the study, to uncover unexpected toxicities that may arise in the context of Ibrutinib and Bortezomib co-administered with the R-CHOP backbone. The safety run-in phase is followed by the phase II part of the trial. About 34 patients will be included. Additional 8-11 German university centers and 1-5 in Austria will participate in this trial. The study treatment includes a pre-phase therapy with Prednisone and 6 cycles of a combined immuno-chemotherapy with the anti-CD20 antibody Rituximab together with 6 cycles of a chemotherapy consisting of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone plus Bortezomib and Ibrutinib followed by two additional 3-week cycles of Rituximab. Secondary endpoints are the predictive power of subtypes (such as GCB/ABC-"cell-of-origin"), markers of minimal residual disease over time and during-the-study-determined markers (e.g. gene signatures) to identify patients who benefit from this treatment addition.
Read the detailed description
Cycle 1 (C1): At C1/day d2, there will be a CT- or ultrasound-guided re-biopsy of a lymphoma lesion that is accessible for biopsy without considerable risk for the patient.
Cycle 2 (C2): After C2, a post-Interim CT will be performed (eventually FDG and FLT PET-CT imaging added to the protocol by amendment).
Cycle 3 (C3): At C3/d0 (prior to therapy), there will also be another bone marrow aspirate for MRD follow-up. At C3/d2, there will be a re-biopsy of a lymphoma site in case of a residual lesion by CT that is accessible for biopsy without considerable risk for the patient. Biopsies can be obtained CT- or ultrasound-guided.
End of treatment/post-therapy: The end-of-treatment visit is required for all subjects, irrespective of a completion of all 8 cycles of therapy or exit of the study protocol. It has to be scheduled approximately 4 to 6 weeks after the last cycle. A total of 7 Follow up visits is planned over 30 months of follow up.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Ibrutinib and Bortezomib + R-CHOP
- Keywords
- Diffuse Large B Cell Lymphoma, Ibrutinib, Bortezomib
- 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.
Ibrutinib and Bortezomib + R-CHOPDrug
Also called Ibrutinib (Imbruvica®), Bortezomib (Velcade®)
A pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals < 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2).
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib and Bortezomib + R-CHOP | Experimental | A pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals < 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2). Receives: Drug: Ibrutinib and Bortezomib + R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival
progression-free survival after 2 years after end of treatment
Measured: 2 years after completion of treatment
Secondary outcomes (7)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion, an average of 3 years
1y- and 2y-PFS for patients based on cell-of-origin (COO, i.e. GCB vs. ABC subtype)
Measured: 1 and 2 years after end of treatment
number of patients with complete remission in all patients and based on cell-of-origin
Measured: 2 years after end of treatment
Predictive power of markers for Minimal Residual Disease (MRD) over time
Measured: 2 years after end of treatment
Objective Response Rate (ORR) in all patients and based on cell-of-origin
Proportion of patients with reduction in tumor burden in all patients and based on cell-of-origin
Measured: 2 years after end of treatment
Disease-Free Survival in all patients and based on cell-of-origin
number of patients with disease-free survival in all patients and based on cell-of-origin
Measured: 2 years after end of treatment
Overall survival in all patients and based on cell-of-origin
Measured: 2 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start17 Mar 2017
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Clemens Schmitt
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Janssen-Cilag Ltd.
- Responsible party
- Sponsor-investigator, Prof. Dr. Clemens Schmitt, Charite University, Berlin, Germany
- Investigators
- Clemens Schmitt, Prof. Dr., Principal investigator, Representative of the Sponsor, National Coordinator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129828
- Sponsor's protocol ID
- EudraCT-Nr.: 2015-003429-32
- Acronym
- ImbruVeRCHOP
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2017
- Last updated
- 13 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denker S, Bittner A, Na IK, Kase J, Frick M, Anagnostopoulos I, Hummel M, Schmitt CA. A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-kappaB-double-targeting to molecularly assess therapy response. Int J Hematol Oncol. 2019 Dec 19;8(4):IJH20. doi: 10.2217/ijh-2019-0010.
PubMed 31903182Vernava I, Schmitt CA. Daratumumab as a novel treatment option in refractory ITP. Blood Cells Mol Dis. 2023 Mar;99:102724. doi: 10.1016/j.bcmd.2023.102724. Epub 2023 Jan 13.
PubMed 36669360
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibrutinib (Imbruvica®), Bortezomib (Velcade®) s.c., Rituximab, CHOP for the Treatment of Elderly Patients (Age 61-80 Years) With CD20+ Diffuse Large B-cell Lymphoma, IPI ≥ 2
- ClinicalTrials.gov ID
- NCT03129828
- Acronym / sponsor ID
- ImbruVeRCHOP / EudraCT-Nr.: 2015-003429-32
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse Large B Cell Lymphoma, Ibrutinib, Bortezomib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Prof. Dr. Clemens SchmittUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Janssen-Cilag Ltd.
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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.
The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective, open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate outcome with clinical, molecular and imaging-guided response parameters. The protocol includes a safety run-in phase, i.e. the phase I part of the study, to uncover unexpected toxicities that may arise in the context of Ibrutinib and Bortezomib co-administered with the R-CHOP backbone. The safety run-in phase is followed by the phase II part of the trial. About 34 patients will be included. Additional 8-11 German university centers and 1-5 in Austria will participate in this trial. The study treatment includes a pre-phase therapy with Prednisone and 6 cycles of a combined immuno-chemotherapy with the anti-CD20 antibody Rituximab together with 6 cycles of a chemotherapy consisting of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone plus Bortezomib and Ibrutinib followed by two additional 3-week cycles of Rituximab. Secondary endpoints are the predictive power of subtypes (such as GCB/ABC-"cell-of-origin"), markers of minimal residual disease over time and during-the-study-determined markers (e.g. gene signatures) to identify patients who benefit from this treatment addition.
Detailed description
Cycle 1 (C1): At C1/day d2, there will be a CT- or ultrasound-guided re-biopsy of a lymphoma lesion that is accessible for biopsy without considerable risk for the patient.
Cycle 2 (C2): After C2, a post-Interim CT will be performed (eventually FDG and FLT PET-CT imaging added to the protocol by amendment).
Cycle 3 (C3): At C3/d0 (prior to therapy), there will also be another bone marrow aspirate for MRD follow-up. At C3/d2, there will be a re-biopsy of a lymphoma site in case of a residual lesion by CT that is accessible for biopsy without considerable risk for the patient. Biopsies can be obtained CT- or ultrasound-guided.
End of treatment/post-therapy: The end-of-treatment visit is required for all subjects, irrespective of a completion of all 8 cycles of therapy or exit of the study protocol. It has to be scheduled approximately 4 to 6 weeks after the last cycle. A total of 7 Follow up visits is planned over 30 months of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib and Bortezomib + R-CHOP | Experimental | Drug: Ibrutinib and Bortezomib + R-CHOPA pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals < 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2). |
Who may qualify
- Ages
- 61 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent indicating that they understand the purpose of and procedures required for the study, including biomarkers and are willing to participate in the study
- Age ≥ 61 years and ≤ 80 years
- CD20-positive diffuse large B-cell lymphoma (DLBCL); including T-cell-rich large B-cell lymphoma, anaplastic large B-cell lymphoma, plasmablastic lymphoma; follicular lymphoma grade 3b or primary transformed follicular lymphoma at initial diagnosis or highgrade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements or high-grade B-cell lymphoma NOS
- Lymphoma biopsy native, fresh-frozen for genome-wide transcriptome array or RNA-Seq analyses (gene expression profiling [GEP]) for molecular subtype diagnosis
- Willingness to consent to a re-biopsy in C1/day d2, and - in case of a residual lesion by interim CT - in C3/d2 if it can be obtained without inadequate risk
Key exclusion criteria (25 listed)
- Unable to sign informed consent
- Secondary transformed B-NHL or types of NHL other than DLBCL and its subtypes according to WHO classification
- Prior therapy for DLBCL
- Known central nervous system lymphoma
- CNS involvement by lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks prior to study entrance) in case of clinical suspicion of CNS involvement by lymphoma
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 |
|---|---|---|
| Ibrutinib and Bortezomib + R-CHOPAlso: Ibrutinib (Imbruvica®), Bortezomib (Velcade®)A pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals < 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2). | Drug | Ibrutinib and Bortezomib + R-CHOP |
Primary outcome
2-year progression-free survival
Time frame: 2 years after completion of treatment
progression-free survival after 2 years after end of treatment
7 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 3 years
1y- and 2y-PFS for patients based on cell-of-origin (COO, i.e. GCB vs. ABC subtype)
Time frame: 1 and 2 years after end of treatment
number of patients with complete remission in all patients and based on cell-of-origin
Time frame: 2 years after end of treatment
Predictive power of markers for Minimal Residual Disease (MRD) over time
Time frame: 2 years after end of treatment
Objective Response Rate (ORR) in all patients and based on cell-of-origin
Time frame: 2 years after end of treatment
Disease-Free Survival in all patients and based on cell-of-origin
Time frame: 2 years after end of treatment
Overall survival in all patients and based on cell-of-origin
Time frame: 2 years after end of treatment
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 13 Dec 2024.
- Background: PubMed 31903182Denker S, Bittner A, Na IK, Kase J, Frick M, Anagnostopoulos I, Hummel M, Schmitt CA. A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-kappaB-double-targeting to molecularly assess therapy response. Int J Hematol Oncol. 2019 Dec 19;8(4):IJH20. doi: 10.2217/ijh-2019-0010.
- Derived from this study: PubMed 36669360Vernava I, Schmitt CA. Daratumumab as a novel treatment option in refractory ITP. Blood Cells Mol Dis. 2023 Mar;99:102724. doi: 10.1016/j.bcmd.2023.102724. Epub 2023 Jan 13.
- 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.
Clemens Schmitt, Prof. Dr. principal investigator
Representative of the Sponsor, National Coordinator, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibrutinib and Bortezomib + R-CHOP in people with Diffuse Large B Cell Lymphoma, run by Prof. Dr. Clemens Schmitt at 1 site in Germany.
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 15 inclusion and 25 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 13 Dec 2024. 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 Germany. 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 combined 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.
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?
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?
2-year progression-free survival (time frame: 2 years after completion of treatment). 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 NCT03129828, which also lists 2 linked publications.
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 13 Dec 2024.