Overview
Sponsor-declared trial summary
Chronic Lymphocytic Leukemia
Evaluate changes in lymph nodes in patients with CLL treated with venetoclaxcontaining regimens at both the molecular and ultrasound level
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Aug 2022 → ongoing
- Decision date (initial)
- 2024-11-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515938-32-00
- EudraCT number
- 2021-000722-96
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Evaluate changes in lymph nodes in patients with CLL treated with venetoclaxcontaining regimens at both the molecular and ultrasound level
Conditions and MedDRA coding
Chronic Lymphocytic Leukemia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosis of CLL
- Candidate patients for treatment with venetoclax-based regimens
- Basal value of platelets> 100x109 / l
- PT INR and aPTT within the limits
Exclusion criteria 1
- Patients receiving antiplatelet and / or anticoagulant therapy that cannot be safely stopped prior to biopsy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Characterization by immunohistochemistry, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and LN-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax ramp-up phase
- Definition of ultrasound characteristics of LNs in CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax acceleration phase
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP16272936 · ATC
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 260190 µg microgram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — VENETOCLAX
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Paolo Ghia
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Paolo Ghia
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Temporarily halted | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Italy | 2022-08-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-79676
- Halt date
- 2024-10-30
- Planned restart
- 2025-07-01
- Member states concerned
- Italy
- Publication date
- 2025-04-18
- Reason
- Study management related
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol | 2.0 |
| Recruitment arrangements (for publication) | Blank document_ not required under directive | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_REDACTED | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_Venetoclax | 12 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Italy | Acceptable 2024-11-14
|
2024-11-19 |