Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
165
Countries
7
Sites
11
Chronic lymphocytic leukemia; Non-Hodgkin's lymphoma; Multiple Myeloma; Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
To obtain long-term safety data for subjects from ongoing venetoclax studies
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Sep 2020 → ongoing
- Decision date (initial)
- 2023-03-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501522-38-00
- EudraCT number
- 2018-004356-38
- ClinicalTrials.gov
- NCT03844048
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To obtain long-term safety data for subjects from ongoing venetoclax studies
Conditions and MedDRA coding
Chronic lymphocytic leukemia; Non-Hodgkin's lymphoma; Multiple Myeloma; Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
| 22.0 | PT | 10029547 | Non-Hodgkin's lymphoma | 100000004864 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 21.1 | LLT | 10054695 | Waldenstrom's macroglobulinemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Subject has completed a prior venetoclax study, and the investigator believes that continued treatment with venetoclax is in the best interest of the patient.
- Subjects are willing or able to comply with procedures required in this protocol.
- Subjects entering the extension study with multiple myeloma must adhere to the following guidelines: • All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must receive prophylaxis with antibiotics while on treatment and for at least 30 days after discontinuation of the proteasome inhibitor and/or venetoclax including: Bactrim forte® (1 tablet, 3 times a week) or equivalent antibiotic therapy AND Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines
- Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Subjects agree to abide by protocol-mandated pregnancy avoidance measures.
Exclusion criteria 3
- Female who is pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
- Male who is considering fathering a child or donating sperm during the study and for approximately 90 days after the last dose of study drug.
- Subjects receiving any live vaccines during study participation including until at least 4 weeks (for all indications except MM) and 8 weeks (for subjects with MM) after the last dose of study drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adverse event collection
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD2186236 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1980 g gram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD2186235 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1980 g gram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Code 14, Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
7 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 3 | 1 |
| Denmark | Ongoing, recruitment ended | 2 | 2 |
| France | Ongoing, recruitment ended | 1 | 1 |
| Greece | Ongoing, recruitment ended | 14 | 2 |
| Ireland | Ended | 2 | 1 |
| Poland | Ongoing, recruitment ended | 6 | 3 |
| Spain | Ongoing, recruitment ended | 1 | 1 |
| Rest of world
United Kingdom, New Zealand, Mexico, Brazil, Japan, Australia, Hong Kong, United States, Korea, Republic of, Ukraine, Taiwan, Canada, Russian Federation, Turkey
|
— | 136 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus University Hospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire Grenoble Alpes
Service d'hematologie, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Laiko General Hospital Of Athens
Haematology Clinic and Βone Μarrow Τransplantation Unit, NKUA, Agiou Thoma (goudi) 17, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department, Exochi, 570 10, Thessaloniki
Beaumont Hospital
Cancer Clinical Trials and Research Unit, Beaumont Road, Beaumont, Dublin 9
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul. Indiry Gandhi 14, 02-776, Warsaw
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych, Ul. Strzelcow Bytomskich 11, 41-500, Chorzow
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 |
|---|---|---|---|---|---|
| Belgium | 2020-12-03 | 2021-02-24 | 2021-03-11 | ||
| Denmark | 2021-05-12 | 2021-06-11 | 2021-09-09 | ||
| France | 2022-02-22 | 2022-04-05 | 2022-04-05 | ||
| Greece | 2021-05-21 | 2021-06-03 | 2021-11-09 | ||
| Ireland | 2021-03-26 | 2024-03-01 | 2021-04-01 | 2021-04-15 | |
| Poland | 2020-09-04 | 2020-10-29 | 2021-08-31 | ||
| Spain | 2021-06-01 | 2021-07-06 | 2021-07-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m19388-protocol-redacted | 9 |
| Protocol (for publication) | D1_m19388-protocol-redacted-EL-GR | 9 |
| Recruitment arrangements (for publication) | M19-388 BE Recruitment and ICF Procedures-public | 1 |
| Recruitment arrangements (for publication) | M19-388 DK Recruitment and ICF Procedures_Study-public | 2 |
| Recruitment arrangements (for publication) | M19-388 ES Recruitment and ICF Procedures - Study-public | 1 |
| Recruitment arrangements (for publication) | M19-388 FR EU CTR Recruitment and ICF Procedures - Country_public | 2 |
| Recruitment arrangements (for publication) | M19-388 GR Recruitment and ICF Procedures - Study_public | 2 |
| Recruitment arrangements (for publication) | M19-388 IE Recruitment and ICF Procedures - Country-public | 2 |
| Recruitment arrangements (for publication) | M19-388 PL EU CTR Recruitment and ICF Procedures -public | 1 |
| Subject information and informed consent form (for publication) | L1 M19-388 IE ICF Main Public | 11 |
| Subject information and informed consent form (for publication) | L1_M19-388 _ES_Main ICF_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_M19-388 BE Main ICF Dutch_public | 10 |
| Subject information and informed consent form (for publication) | L1_M19-388 BE Main ICF English_public | 10 |
| Subject information and informed consent form (for publication) | L1_M19-388 BE Main ICF French_public | 10 |
| Subject information and informed consent form (for publication) | L1_M19-388 DK ICF Main_public | 8 |
| Subject information and informed consent form (for publication) | L1_M19-388 FR - Pregnant Partner ICF_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M19-388 FR Main ICF_Public | 10.1 |
| Subject information and informed consent form (for publication) | L1_M19-388 GR - ICF Main_public | 17 |
| Subject information and informed consent form (for publication) | L1_M19-388 PL ICF Main_Public | 10 |
| Subject information and informed consent form (for publication) | M19-388 BE - ICF PP Country Sample French_public | 2 |
| Subject information and informed consent form (for publication) | M19-388 BE - ICF PP Country Sample_public | 2 |
| Subject information and informed consent form (for publication) | M19-388 BE - ICF PP Country Sample_public | 2 |
| Subject information and informed consent form (for publication) | M19-388 DK - POA to Main ICF_public | 1 |
| Subject information and informed consent form (for publication) | M19-388 GR - ICF PregPart IRB_public | 1 |
| Subject information and informed consent form (for publication) | M19-388 IE - Summary Patient Information Sheet_public | 1 |
| Subject information and informed consent form (for publication) | M19-388 IE - ICF Main_Redacted_public | 6 |
| Subject information and informed consent form (for publication) | M19-388 IE - ICF PP_Redacted_public | 1 |
| Subject information and informed consent form (for publication) | M19-388 IE - ICF PP- Country Sample_Redacted_public | 1 |
| Subject information and informed consent form (for publication) | M19-388 IE - Subject Information Leaflet localised_public | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR Synopsis_EN | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR Synopsis_ES-ES | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR Synopsis_FR-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR Synopsis_NL-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR-synopsis_DE-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR-Synopsis_EL-GR | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR-synopsis_FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_m19-388-EU CTR-synopsis_PL-PL | 1 |
| Synopsis of the protocol (for publication) | M19-388 Danish Addendum to Protocol_public | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-27 | Poland | No conclusion 2023-03-06
|
2023-03-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-02 | Poland | Acceptable 2023-10-02
|
2023-10-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-30 | Poland | Acceptable 2024-08-12
|
2024-08-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-30 | Poland | Acceptable 2024-11-25
|
2024-11-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-02 | Poland | Acceptable 2025-06-23
|
2025-06-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-23 | Acceptable | 2025-11-04 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-14 | Acceptable | 2025-11-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-31 | Acceptable 2026-05-31
|
2026-06-01 |