Clinical Trial Results:
Venetoclax, lenalidomide and rituximab in patients with relapsed/refractory mantle cell lymphoma.
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Summary
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EudraCT number |
2017-001060-38 |
Trial protocol |
SE NO DK FI |
Global end of trial date |
01 Dec 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2025
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First version publication date |
29 Jun 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NLG-MCL7
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03505944 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Skåne University Hospital
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Sponsor organisation address |
Department of Oncology, Lund, Sweden, 221085
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Public contact |
Academic Clinical trial office, Nordic Lymphoma Group, Department of Hematology, Aarhus University Hospital, +45 7845 5855, a-cto@auh.rm.dk
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Scientific contact |
Academic Clinical trial office, Nordic Lymphoma Group, Department of Hematology, Aarhus University Hospital, +45 7845 5855, a-cto@auh.rm.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Nov 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Nov 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Dec 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to assess the overall response rate (ORR) at 6 months with lenalidomide-venetoclax and rituximab, in patients with relapsed or refractory mantle cell lymphoma, by use of an MRD driven strategy.
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Protection of trial subjects |
The study was conducted according to the guidelines for Good Clinical Practice, issued by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The protocol was approved by the local, regional or national Ethical Review Boards according to the existing national and local regulatory requirements. The study was conducted in agreement with the declaration of Helsinki and the laws and the regulations of the respective countries.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Norway: 16
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Country: Number of subjects enrolled |
Sweden: 29
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Country: Number of subjects enrolled |
Denmark: 12
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Country: Number of subjects enrolled |
Finland: 2
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Worldwide total number of subjects |
59
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EEA total number of subjects |
59
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9
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From 65 to 84 years |
50
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85 years and over |
0
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Recruitment
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Recruitment details |
Overall 59 patients were included in the trial. 15 Nordic sites contributed to the study. The first patient was included on 07-Jul-2018. The last patient was included on 29-Apr-2021. | ||||||||||||
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Pre-assignment
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Screening details |
Patients were screened for the complete list of inclusion and exclusion criteria according to the protocol. | ||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Treatment | ||||||||||||
Arm description |
Single arm study Phase 1 tested dose groups A, B, C, Y Phase 2 applied the dose schedule of phase 1 dose group Y | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Venetoclax
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Phase 1 dose group A+B: 400 mg po daily (after ramp-up dosing of 20 mg, 50 mg, 100 mg, 200 mg, for one week each)
Phase 1 dose group C: 800 mg po daily (after ramp-up dosing of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, for one week each)
Phase 1 dose group C + Phase 2: 600 mg po daily (after ramp-up dosing of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, for one week each)
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Investigational medicinal product name |
lenalidomide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Phase 1 dose group A: 15 mg po days 1-21 in cycles of 28 days
Phase 1 dose group B+C: 20 mg po days 1-21 in cycles of 28 days
Phase 1 dose group Y + Phase 2: 15 mg po days 1-21 in cycles of 28 days
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Single arm study Phase 1 tested dose groups A, B, C, Y Phase 2 applied the dose schedule of phase 1 dose group Y | ||
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End point title |
Overall response rate [1] | ||||||
End point description |
The primary objective is to assess the overall response rate (ORR) at 6 months with lenalidomide-venetoclax and rituximab, in patients with relapsed or refractory mantle cell lymphoma, by use of an MRD driven strategy. ORR includes complete (CR) and partial remissions (PR).
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End point type |
Primary
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End point timeframe |
6 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analyses is described in the publication - see reference |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs will be recorded from the time the subject signs informed consent to 28 days after the last dose of study drug.
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Adverse event reporting additional description |
For grade 1-2 events, only the ones occurring in 10% or more of patients are reported. Haematological adverse events less than grade 3 were not reported.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Single arm study Phase 1 tested dose groups A, B, C, Y Phase 2 applied the dose schedule of phase 1 dose group Y | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Feb 2019 |
Introduced Dose Group Y |
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08 Feb 2021 |
Removed cohort of 15 untreated patients |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/38113470 |
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