Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
324
Countries
1
Sites
25
Diffuse large B-cell lymphoma (DLBCL)
To establish the efficacy of dexrazoxane for the primary prevention of AICD in DLBCL patients treated with R-CHOP21 and to compare complete metabolic response (CMR) rates between treatment arms.
Key facts
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 15 Aug 2024 → ongoing
- Decision date (initial)
- 2024-05-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505377-32-00
- ClinicalTrials.gov
- NCT06220032
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To establish the efficacy of dexrazoxane for the primary prevention of AICD in DLBCL patients treated with R-CHOP21 and to compare complete metabolic response (CMR) rates between treatment arms.
Secondary objectives 6
- To assess whether there is a difference in LVEF (2D or 3D) and global longitudinal strain (GLS) between treatment arms.
- To assess whether there is a difference in release of cardiac biomarkers (troponin, NTpro-BNP) between treatment arms.
- To determine the incidence of Major Adverse Cardiovascular Events (MACE).
- To evaluate adverse events.
- To identify patient- and treatment related factors modulating individual AICD risk and develop a risk stratification model.
- To analyse the impact of the addition of dexrazoxane on QoL.
Conditions and MedDRA coding
Diffuse large B-cell lymphoma (DLBCL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to the WHO classification 2022: DLBCL, not otherwise specified (NOS); High-grade B-cell lymphoma NOS; High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation when DA-EPOCH-R is not an option (R2-CHOP is allowed); Follicular lymphoma; T-cell/histiocyte-rich B cell lymphoma (THRBCL).
- Planned treatment with 6 R-CHOP21. The following regimens are also allowed: Treatment with reversed R-CHOP21; Treatment with R2-CHOP21 (6 R-CHOP21 + lenalidomide 15 mg day 1-14) in case of double hit lymphoma; Two additional administrations of rituximab after 6 cycles of R-CHOP21; High dosis MTX and/or MTX-it for CNS prophylaxis.
- Ann Abor stages II-IV and stage I if the treatment plan is 6 R-CHOP21 in case of bulky disease (defined as a ≥10 cm mass).
- Age ≥ 18 years.
- WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL.
- Negative pregnancy test at study entry for women of childbearing potential.
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice two effective methods of contraception, at the same time, from the time of signing the informed consent through at least 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse.
- Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse.
- Patient is able to adhere to the study visit schedule and other protocol requirements.
- Written informed consent.
Exclusion criteria 16
- Any of the following B-cell lymphomas according to WHO classification 2022: Central Nervous System involvement by DLBCL (high CNS-IPI is allowed); Testicular DLBCL; Primary mediastinal B-cell lymphoma; Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder.
- Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is allowed in case the heart has not been exposed.
- Patients requiring treatment with mini-R-CHOP.
- Pre-existing cardiac disease including: LVEF <50% measured with echocardiography (2D or 3D); Symptomatic heart failure (NYHA ≥II) or hospitalization for heart failure in the last year; Refractory anginal symptoms; Cardiac arrhythmias not controlled with optimal medical treatment, in case of atrial fibrillation the ventricular response needs to be <110/min; Significant valvular dysfunction on echocardiography; Non-ischemic cardiomyopathy.
- Non-diagnostic/poor transthoracic echocardiography imaging quality at baseline.
- Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL.
- Severe neurological or psychiatric disease.
- Inadequate hematological function (absolute Neutrophil Count (ANC) <1.0x109 /L or platelets <75x109 /L), unless clearly related to DLBCL.
- Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver.
- Active hepatitis B or C infection (serology testing is required at screening). Patients positive for hepatitis B surface antigen (HBsAg) regardless of antibody status or HBsAg negative but anti-HBc positive are only eligible if HBV-PCR is negative and patients are protected with lamuvidine or entecavir. Patients with positive hepatitis C serology are only eligible if HCV-(RNA) is confirmed negative.
- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration) or requiring dialysis.
- Active uncontrolled fungal, bacterial and/or viral infection.
- Patient known to be HIV-positive.
- Breast-feeding female patients.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The incidence of AICD (measured with 2D) within 12-months after registration.
- Complete metabolic remission (CMR) on 18F-FDG PET-CT at end of treatment 6-8 weeks after completion of 6x R-CHOP21.
Secondary endpoints 9
- Overall survival (OS) at 12-months.
- Progression-free survival (PFS) at 12-months.
- LVEF (2D and 3D) and global longitudinal strain (GLS) at end of treatment and 12-months after start of treatment.
- NYHA functional class.
- Release of cardiac biomarkers.
- Quality of Life score.
- Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Incidence of secondary malignancies.
- Major Adverse Cardiovascular Events (MACE) at 1-, 2-, 5- and 10-years.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cardioxane 500 mg poeder voor oplossing voor infusie.
PRD2516696 · Product
- Active substance
- Dexrazoxane
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AF02 — DEXRAZOXANE
- Marketing authorisation
- RVG 33196
- MA holder
- CLINIGEN HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 25
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16451MIG · Substance
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 36 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00059MIG · Substance
- Active substance
- Vincristine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06391MIG · Substance
- Active substance
- Doxorubicin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 1260 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00059MIG · Substance
- Active substance
- Vincristine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg/m2 milligram(s)/square meter
- Max total dose
- 12 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
- Sponsor organisation
- Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Haemato Oncology Foundation For Adults Netherlands
- Contact name
- Dr. J.M.I. de Vos
Public contact point
- Organisation
- Haemato Oncology Foundation For Adults Netherlands
- Contact name
- HOVON
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Universitair Medisch Centrum Utrecht ORG-100008351
|
Utrecht, Netherlands | Other |
| Universitair Medisch Centrum Utrecht ORG-100008351
|
Utrecht, Netherlands | Code 14 |
| Amsterdam UMC ORG-100008355
|
Amsterdam, Netherlands | Other |
| Universitair Medisch Centrum Utrecht ORG-100008351
|
Utrecht, Netherlands | Other |
Sponsor responsibilities
- Contact point sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
Locations
1 EU/EEA country · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 324 | 25 |
| Rest of world | — | 0 | — |
Investigational sites
Reinier de Graaf Groep
Hematology, Reinier De Graafweg 5, 2625 AD, Delft
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Hematology, Tegelseweg 210, 5912 BL, Venlo
Jeroen Bosch Ziekenhuis
Hematology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Spaarne Gasthuis Stichting
Hematology, Spaarnepoort 1, 2134 TM, Hoofddorp
Admiraal De Ruyter Ziekenhuis B.V.
Hematology, 'S-Gravenpolderseweg 114, 4462 RA, Goes
Ziekenhuis St Jansdal
Hematology, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Haga Hospital
Hematology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Sint Franciscus Vlietland Groep Stichting
Hematology, Vlietlandplein 2, 3118 JH, Schiedam
Albert Schweitzer Ziekenhuis
Hematology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Rijnstate Ziekenhuis Stichting
Hematology, Wagnerlaan 55, 6815 AD, Arnhem
Ziekenhuis Amstelland
Hematology, Laan Van De Helende Meesters 8, 1186 AM, Amstelveen
Stichting Martini Ziekenhuis
Hematology, Van Swietenplein 1, 9728 NT, Groningen
Amphia Hospital
Hematology, Molengracht 21, 4818 CK, Breda
Ziekenhuisgroep Twente Stichting
Hematology, Zilvermeeuw 1, 7609 PP, Almelo
Catharina Ziekenhuis Stichting
Hematology, Michelangelolaan 2, 5623 EJ, Eindhoven
Maxima Medisch Centrum
Hematology, Ds Theodor Fliednerstraat 1, 5631 BM, Eindhoven
Zuyderland Medisch Centrum Stichting
Hematology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Isala Klinieken Stichting
Hematology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Antonius ziekenhuis Sneek
Hematology, Bolswarderbaan 1, 8601ZK, Sneek
Canisius Wilhelmina Hospital
Hematology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Ikazia Ziekenhuis
Hematology, Montessoriweg 1, 3083 AN, Rotterdam
Tergooiziekenhuizen
Hematology, Van Riebeeckweg 212, 1213 XZ, Hilversum
Gelre Hospitals
Hematology, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Sint Antonius Ziekenhuis Stichting
Hematology, Koekoekslaan 1, 3435 CM, Nieuwegein
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-08-15 | 2024-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 HO170 Protocol 2023-505377-32 Redacted | 3 |
| Recruitment arrangements (for publication) | K1 HO170 Recruitment arrangements NL | 2 |
| Subject information and informed consent form (for publication) | L1 HO170 SIS and ICF main Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 HO170 SIS and ICF Pregnancy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC Cardioxane 500 mg | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC Cardioxane NL | 0 |
| Synopsis of the protocol (for publication) | D1 HO170 Protocol synopsis EN 2023-505377-32 | 2 |
| Synopsis of the protocol (for publication) | D1 HO170 Protocol synopsis NL 2023-505377-32 | 2 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-08 | Netherlands | Acceptable 2024-05-13
|
2024-05-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-07 | Netherlands | Acceptable 2024-05-13
|
2024-06-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-22 | Netherlands | Acceptable 2025-03-12
|
2025-03-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-12 | Netherlands | Acceptable | 2026-03-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-18 | Netherlands | Acceptable | 2026-04-21 |