LymphomaNCT02916316
Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell
An observational study of Lymphoma and Large B-Cell, run by Fondazione Italiana Linfomi - ETS at 18 sites in Italy.
Trial summary
All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse Large B-Cell
- What is being tested?
- R-CHOP with doxorubicin
- Type of treatment
- Injection or infusion
- How many people
- 127 participants
- Where
- 18 sitesItaly
- Study dates
- 12 Feb 2014to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diffuse Large B-Cell Lymphoma
Who may be able to join
- Histologically confirmed Diffuse Large B-Cell Lymphoma diagnosis
- Patient eligible to receive 6 cycles of R-CHOP or R-CHOP like chemotherapy at full doses
- Age ≥ 18
- Stage I-IV
- Written informed consent
- ECOG Performance Status 0-3
Show all 11Show fewer
- Ventricular Ejection Fraction (VEF) ≥40%
- No previous treatment for lymphoma (except for RT-IF)
- Negative β-HCG pregnancy test result at diagnosis for female of childbearing potential
- Use of acceptable method of contraception during the study and for 3 months after receiving the last dose of study drug for patients with childbearing potential
- Availability of the patient to be followed for all the phases of the chemotherapy treatment and for the subsequent follow-up
Who cannot join
- Inability to schedule a treatment at full doses of chemoimmunotherapy R-CHOP or R-CHOP-like for different reasons
- Central nervous system involvement due to lymphoma
- HIV
- Active cardiac pathology including heart failure, left ventricular dysfunction documented by a LVEF <40%, arrhythmias (rapid atrial fibrillation, frequent ventricular arrhythmias), valvular aortic or mitral disfunction > moderate, ischemic heart disease (myocardial infarction or acute coronary syndrome for over 6 months, angina at rest or with mild efforts)
- Previous treatment for lymphoma
- Other malignancy in the 3 years prior to the diagnosis of lymphoma with exception of non-melanoma skin cancer or in situ carcinoma
- Any other co-existing medical condition that would preclude participation in the study (uncontrolled bacterial or viral or fungal infection)
- Pregnant, or lactating and breastfeeding female
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, 60126
Ospedale S. Giacomo di Castelfranco Veneto
Castelfranco Veneto
Ospedale Riuniti di Foggia
Foggia
UO Ematologia PO Vito Fazzi
Lecce
AO Riuniti Papardo Piemonte
Messina, ME, 98158
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
A.O. Universitaria Policlinico Di Modena
Modena, MO, 41124
AOU Universitа degli Studi della Campania Luigi Vanvitelli
Naples
Istituto Oncologico Veneto
Padova, 35128
Ospedali Riuniti Villa Sofia - Cervello
Palermo, PA, 90146
U.O. Complessa di Ematologia Ospedale di Parma
Parma, 43100
UO Ematologia e CTMO di Piacenza
Piacenza, PC, 29121
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, 50139
Ematologia e Trapianto Istituto Regina Elena IFO
Roma
Osp.Sant'Eugenio Divisione di Ematologia
Roma
Istituto Clinico Humanitas
Rozzano, MI
Nuovo Ospedale Di Sassuolo S.P.A.
Sassuolo, Modena, 41049
Ospedale Ca Foncello
Treviso
About this study
Official title: Prospective Observational Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell
All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
Read the detailed description
The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.
Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.
With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%.
- Conditions
- Lymphoma, Large B-Cell, Diffuse Large B-Cell
- Being tested
- R-CHOP with doxorubicin
- Keywords
- Lymphoma, Large B-Cell, Cardiotoxicity
- Medical subject headings
- Lymphoma, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CHOP with doxorubicinDrug
Also called R-CHOP with doxorubicin analogue, R-COMP
Chemoimmunotherapy every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
| Study group | Role | What they receive |
|---|---|---|
| Chemo immunotherapy | All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP. Receives: Drug: R-CHOP with doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013
Measured: 1 year from enrollment
Secondary outcomes (7)
Overall response rate (ORR)
defined according to international criteria (Cheson 2007)
Measured: 6 months from enrollment
Rate of response to treatment
defined according to international criteria (Cheson 2007)
Measured: 6 months from enrollment
Overall survival (OS)
It will be calculated for all patients enrolled in the study from the date of start of therapy to the date of death or last follow-up.
Measured: 3 years from enrollment
Progression-free survival (PFS)
It will be calculated for all patients from the start of therapy given to the date of progression or death or last follow-up.
Measured: 3 years from enrollment
failure-free survival (FFS)
It will be calculated for all patients from the therapy start date to the date of an event or last follow-up.
The events considered for the FFS definition are the following: treatment discontinuation for toxicity, response <RC, relapse / progression, death for any cause.
Measured: 3 years from enrollment
Freedom From cardiovascular Event (FFCE)
calculated for all patients from the therapy start date to the time of occurrence of a cardiovascular event as defined by primary endopoint or follow-up date.
Measured: 3 years from enrollment
Number of events recorded during the treatment and codified according to NCI-CTC v4.03
it will be defined by the number of events recorded during the treatment and codified according to NCI-CTC v4.03
Measured: 3 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start12 Feb 2014
- Primary completion30 Dec 2020
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Gini, MD, Principal investigator, AOU Ospedali Riuniti, Ematologia ANCONA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916316
- Sponsor's protocol ID
- FIL_Cardio-DLBCL
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2016
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. No abstract available.
PubMed 8068936Fisher RI, Gaynor ER, Dahlberg S, Oken MM, Grogan TM, Mize EM, Glick JH, Coltman CA Jr, Miller TP. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med. 1993 Apr 8;328(14):1002-6. doi: 10.1056/NEJM199304083281404.
PubMed 7680764International Non-Hodgkin's Lymphoma Prognostic Factors Project. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med. 1993 Sep 30;329(14):987-94. doi: 10.1056/NEJM199309303291402.
PubMed 8141877Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.
PubMed 12920037Pfreundschuh M, Trumper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rube C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. doi: 10.1182/blood-2003-06-2094. Epub 2004 Feb 24.
PubMed 14982884Pfreundschuh M, Trumper L, Kloess M, Schmits R, Feller AC, Rube C, Rudolph C, Reiser M, Hossfeld DK, Eimermacher H, Hasenclever D, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):634-41. doi: 10.1182/blood-2003-06-2095. Epub 2004 Mar 11.
PubMed 15016643Balzarotti M, Spina M, Sarina B, Magagnoli M, Castagna L, Milan I, Ripa C, Latteri F, Bernardi D, Bertuzzi A, Nozza A, Roncalli M, Morenghi E, Tirelli U, Santoro A. Intensified CHOP regimen in aggressive lymphomas: maximal dose intensity and dose density of doxorubicin and cyclophosphamide. Ann Oncol. 2002 Sep;13(9):1341-6. doi: 10.1093/annonc/mdf242.
PubMed 12196358Vitolo U, Liberati AM, Cabras MG, Federico M, Angelucci E, Baldini L, Boccomini C, Brugiatelli M, Calvi R, Ciccone G, Genua A, Deliliers GL, Levis A, Parvis G, Pavone E, Salvi F, Sborgia M, Gallo E; Intergruppo Italiano Linfomi. High dose sequential chemotherapy with autologous transplantation versus dose-dense chemotherapy MegaCEOP as first line treatment in poor-prognosis diffuse large cell lymphoma: an "Intergruppo Italiano Linfomi" randomized trial. Haematologica. 2005 Jun;90(6):793-801.
PubMed 15951292Wilson WH. Chemotherapy sensitization by rituximab: experimental and clinical evidence. Semin Oncol. 2000 Dec;27(6 Suppl 12):30-6.
PubMed 11225998Demidem A, Lam T, Alas S, Hariharan K, Hanna N, Bonavida B. Chimeric anti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Biother Radiopharm. 1997 Jun;12(3):177-86. doi: 10.1089/cbr.1997.12.177.
PubMed 10851464
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell
- ClinicalTrials.gov ID
- NCT02916316
- Acronym / sponsor ID
- FIL_Cardio-DLBCL
- Conditions
- Lymphoma, Large B-Cell, Diffuse Large B-Cell
- Keywords
- Lymphoma, Large B-Cell, Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 12 Feb 2014 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
Detailed description
The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.
Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.
With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo immunotherapy | – | Drug: R-CHOP with doxorubicinAll patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diffuse Large B-Cell Lymphoma
Key inclusion criteria (11 listed)
- Histologically confirmed Diffuse Large B-Cell Lymphoma diagnosis
- Patient eligible to receive 6 cycles of R-CHOP or R-CHOP like chemotherapy at full doses
- Age ≥ 18
- Stage I-IV
- Written informed consent
Key exclusion criteria (8 listed)
- Inability to schedule a treatment at full doses of chemoimmunotherapy R-CHOP or R-CHOP-like for different reasons
- Central nervous system involvement due to lymphoma
- HIV
- Active cardiac pathology including heart failure, left ventricular dysfunction documented by a LVEF <40%, arrhythmias (rapid atrial fibrillation, frequent ventricular arrhythmias), valvular aortic or mitral disfunction > moderate, ischemic heart disease (myocardial infarction or acute coronary syndrome for over 6 months, angina at rest or with mild efforts)
- Previous treatment for 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 |
|---|---|---|
| R-CHOP with doxorubicinAlso: R-CHOP with doxorubicin analogue, R-COMPChemoimmunotherapy every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP. | Drug | Chemo immunotherapy |
Primary outcome
Cardiotoxicity
Time frame: 1 year from enrollment
defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013
7 secondary outcomes
Overall response rate (ORR)
Time frame: 6 months from enrollment
Rate of response to treatment
Time frame: 6 months from enrollment
Overall survival (OS)
Time frame: 3 years from enrollment
Progression-free survival (PFS)
Time frame: 3 years from enrollment
failure-free survival (FFS)
Time frame: 3 years from enrollment
Freedom From cardiovascular Event (FFCE)
Time frame: 3 years from enrollment
Number of events recorded during the treatment and codified according to NCI-CTC v4.03
Time frame: 3 years from enrollment
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 18 Nov 2025.
- Background: PubMed 8068936Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. No abstract available.
- Background: PubMed 7680764Fisher RI, Gaynor ER, Dahlberg S, Oken MM, Grogan TM, Mize EM, Glick JH, Coltman CA Jr, Miller TP. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med. 1993 Apr 8;328(14):1002-6. doi: 10.1056/NEJM199304083281404.
- Background: PubMed 8141877International Non-Hodgkin's Lymphoma Prognostic Factors Project. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med. 1993 Sep 30;329(14):987-94. doi: 10.1056/NEJM199309303291402.
- Background: PubMed 12920037Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.
- Background: PubMed 14982884Pfreundschuh M, Trumper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rube C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. doi: 10.1182/blood-2003-06-2094. Epub 2004 Feb 24.
- Background: PubMed 15016643Pfreundschuh M, Trumper L, Kloess M, Schmits R, Feller AC, Rube C, Rudolph C, Reiser M, Hossfeld DK, Eimermacher H, Hasenclever D, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):634-41. doi: 10.1182/blood-2003-06-2095. Epub 2004 Mar 11.
- Background: PubMed 12196358Balzarotti M, Spina M, Sarina B, Magagnoli M, Castagna L, Milan I, Ripa C, Latteri F, Bernardi D, Bertuzzi A, Nozza A, Roncalli M, Morenghi E, Tirelli U, Santoro A. Intensified CHOP regimen in aggressive lymphomas: maximal dose intensity and dose density of doxorubicin and cyclophosphamide. Ann Oncol. 2002 Sep;13(9):1341-6. doi: 10.1093/annonc/mdf242.
- Background: PubMed 15951292Vitolo U, Liberati AM, Cabras MG, Federico M, Angelucci E, Baldini L, Boccomini C, Brugiatelli M, Calvi R, Ciccone G, Genua A, Deliliers GL, Levis A, Parvis G, Pavone E, Salvi F, Sborgia M, Gallo E; Intergruppo Italiano Linfomi. High dose sequential chemotherapy with autologous transplantation versus dose-dense chemotherapy MegaCEOP as first line treatment in poor-prognosis diffuse large cell lymphoma: an "Intergruppo Italiano Linfomi" randomized trial. Haematologica. 2005 Jun;90(6):793-801.
- Background: PubMed 11225998Wilson WH. Chemotherapy sensitization by rituximab: experimental and clinical evidence. Semin Oncol. 2000 Dec;27(6 Suppl 12):30-6.
- Background: PubMed 10851464Demidem A, Lam T, Alas S, Hariharan K, Hanna N, Bonavida B. Chimeric anti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Biother Radiopharm. 1997 Jun;12(3):177-86. doi: 10.1089/cbr.1997.12.177.
- 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.
Guido Gini, MD principal investigator
AOU Ospedali Riuniti, Ematologia ANCONA
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Large B-Cell, run by Fondazione Italiana Linfomi - ETS at 18 sites in Italy.
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 11 inclusion and 8 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. 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.
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?
Cardiotoxicity (time frame: 1 year from enrollment). 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 NCT02916316, which also lists 10 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 18 Nov 2025.