Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
30
Countries
3
Sites
6
Relapsed/Refractory Mantle Cell Lymphoma
To provide continued access to study treatment for participants who continued to benefit from treatment
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Nov 2022 → 26 Sep 2024
- Decision date (initial)
- 2023-11-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503618-64-00
- EudraCT number
- 2022-000364-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Safety, Therapy
To provide continued access to study treatment for participants who continued to benefit from treatment
Conditions and MedDRA coding
Relapsed/Refractory Mantle Cell Lymphoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Adult patients with confirmed MCL
- At least 1 prior treatment regimen for MCL excl. BTKi
- Documented disease progression or relapse following the last anti-MCL treatment
- Measurable nodal disease
- ECOG ≤1
- Adequate organ function: ANC ≥ 1000/mm3 Platelets ≥50,000 cells/mm3 Hemoglobin ≥8 g/dL ALT/AST ≤3 X ULN Total bilirubin ≤1.5 X ULN CrCl ≥30 mL/min
- Must not be diagnosed or treated for malignancy other than MCL (with exceptions)
- FOCBP and male participants with partners of childbearing potential must also comply with strict pregnancy prevention plan
Exclusion criteria 11
- Prior therapy with BTKi
- Prior therapy with both Lenalidomide and Bortezomib
- Major surgery within 4 weeks
- History of stroke or intracranial hemorrhage within 6 month prior to randomization
- Central nervous system lymphoma
- Bleeding disorder
- Clinically significant cardiovascular disease (e.g., uncontrolled arrhythmia, or Class II-IV congestive heart failure as defined by NYHA); or a history of MI, unstable angina, or acute coronary syndrome within 1 year prior to randomization (if >1 yr., a cardiology consultation documenting cardiac clearance is required) or uncontrolled HTN under treatment with 3 or more HTN medications, screening systolic BP>160 mm HG or diastolic BP>100mm Hg
- Anticancer therapy including chemotherapy, radiotherapy, small molecule, monoclonal antibody and investigational agents ≤21 days (or at least 5 drug half-lives, whichever is shorter) prior to first administration of study treatment
- Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, or interfere with the absorption or metabolism of ibrutinib (including uncontrolled diabetes mellitus or HbA1C>7)
- Known history of HIV
- Active Hep B/C and E infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- None
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10333688 · Product
- Active substance
- Ibrutinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 426720 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
IMBRUVICA 140 mg hard capsules
PRD1729393 · Product
- Active substance
- Ibrutinib
- Substance synonyms
- 1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 426720 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EL01 — -
- Marketing authorisation
- EU/1/14/945/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 12
Lenalidomide Accord 20 mg hard capsules
PRD6773400 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/010
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 10 mg hard capsules
PRD6773397 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/007
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 2.5 mg hard capsules
PRD6773392 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 2.5 mg hard capsules
PRD6773391 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773393 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/003
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773399 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/009
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 10 mg hard capsules
PRD6773396 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/006
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 20 mg hard capsules
PRD9244618 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/013
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773394 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/004
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773398 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 15200 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/008
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 1.3 mg/m2 milligram(s)/square meter
- Max total dose
- 988 mg/m2 milligram(s)/square meter
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ruxience 500 mg concentrate for solution for infusion
PRD7980794 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 285000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CITIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CITIS Point of Contact
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Data management |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Data management |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Boston, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | Other |
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 1 | 1 |
| Poland | Ended | 3 | 4 |
| Spain | Ended | 3 | 1 |
| Rest of world
Thailand, Brazil, Taiwan, Turkey, Malaysia
|
— | 23 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika - hematologie, U Nemocnice 499/2, Nove Mesto, Prague 2
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
KLINIKA HEMATOLOGII I TRANSPLANTACJI SZPIKU, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddzial Hematologii, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworow Ukladu Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
KLINIKA HEMATOONKOLOGII I TRANSPLANTACJI SZPIKU, Ul. Stanislawa Staszica 11, 20-081, Lublin
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 |
|---|---|---|---|---|---|
| Czechia | 2023-01-05 | 2024-01-16 | 2023-01-05 | 2023-03-29 | |
| Poland | 2023-02-08 | 2024-09-18 | 2023-02-08 | 2023-03-14 | |
| Spain | 2022-11-16 | 2023-12-01 | 2022-11-16 | 2023-04-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 54179060MCL3004 Summary of Results SUM-99209
|
2025-09-25T14:12:58 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 54179060MCL3004_Lay Person Summary of Results_POL | 2025-09-25T14:13:54 | Submitted | Laypersons Summary of Results |
| 54179060MCL3004_Lay Person Summary of Results_GRC | 2025-09-25T14:13:46 | Submitted | Laypersons Summary of Results |
| 54179060MCL3004_Lay Person Summary of Results_ESP | 2025-09-25T14:13:36 | Submitted | Laypersons Summary of Results |
| 54179060MCL3004_Lay Person Summary of Results_CZE | 2025-09-25T14:13:22 | Submitted | Laypersons Summary of Results |
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 54179060MCL3004_Lay Person Summary of Results_CZE_Czech | 1 |
| Laypersons summary of results (for publication) | 54179060MCL3004_Lay Person Summary of Results_ESP_Spanish | 1 |
| Laypersons summary of results (for publication) | 54179060MCL3004_Lay Person Summary of Results_GRC_Greek | 1 |
| Laypersons summary of results (for publication) | 54179060MCL3004_Lay Person Summary of Results_POL_Polish | 1 |
| Summary of results (for publication) | 54179060MCL3004 Summary of Results | 18.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-26 | Spain | Acceptable 2023-11-17
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-21 | Spain | Acceptable 2024-04-18
|
2024-04-18 |