Chronic Lymphocytic Leukemia in RelapsePhase 2NCT03226301
A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations
A Phase 2 study testing Ibrutinib + Venetoclax 15 cycles, Ibrutinib until progression/relapse and Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles in people with Chronic Lymphocytic Leukemia in Relapse and Chronic Lymphocytic Leukemia in Remission, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 49 sites in 6 countries.
Trial summary
The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia in Relapse, Chronic Lymphocytic Leukemia in Remission
- What is being tested?
- Ibrutinib + Venetoclax 15 cycles, Ibrutinib until progression/relapse and Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 23 Jun 2017to 21 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented CLL or SLL requiring treatment according to IWCLL criteria after either being refractory to first line therapy or relapse after initial therapy.
- Age at least 18 years.
- Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) >0.75 x 109/L
- Platelet count >30,000 /μL 30 x 109/L.
- Hemoglobin >8.0 g/dL (5 mmol/L) Unless directly attributable to CLL infiltration of the bone marrow, proven by bone marrow biopsy
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- Creatinine clearance (CrCL) ≥ 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection.
- Adequate liver function as indicated
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN)
- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin)
- Prothrombin time (PT)/International normal ratio (INR) <1.5 x ULN and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are related to coagulopathy or bleeding disorder).
- Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last dose), negative testing for hepatitis C RNA within 42 days prior to registration.
- WHO/ECOG performance status 0-3 (appendix C), stage 3 only if attributable to CLL.
- Negative pregnancy test at study entry (for women of childbearing potential).
- Male and female subjects of reproductive potential must agree to use both a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements.
- Written informed consent.
Who cannot join
- Any prior therapy with ibrutinib and/or venetoclax.
- Transformation of CLL (Richter's transformation).
- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML).
- Malignancies other than CLL currently requiring systemic therapies or not being treated in curative intention before or showing signs of progression after curative treatment.
- Known allergy to xanthine oxidase inhibitors and/or rasburicase.
- Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).
Show all 15Show fewer
- Uncontrolled or active infection.
- Patients requiring treatment with a strong cytochrome P450 (CYP) 3A inhibitor (see appendix K). or anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists. Please note: Patients being treated with NOACs can be included, but must be properly informed about the potential risk of bleeding under treatment with ibrutinib.
- History of stroke or intracranial hemorrhage within 6 months prior to registration.
- Major surgery within 28 days prior to registration.
- Use of investigational agents which might interfere with the study drug within 28 days prior to registration.
- Vaccination with live vaccines within 28 days prior to registration
- Steroid therapy within 7 days prior to registration, with the exception of inhaled steroids for asthma, topical steroids, steroids up to 25 mg of prednisolone daily to control autoimmune phenomenon's, or replacement/stress corticosteroids.
- Pregnant women and nursing mothers.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
Netherlands26 sites
NL-Alkmaar-NWZ
Alkmaar
NL-Amersfoort-MEANDERMC
Amersfoort
NL-Amsterdam-AMC
Amsterdam
NL-Amsterdam-AVL
Amsterdam
NL-Amsterdam-VUMC
Amsterdam
NL-Arnhem-RIJNSTATE
Arnhem
NL-Breda-AMPHIA
Breda
NL-Delft-RDGG
Delft
NL-Dordrecht-ASZ
Dordrecht
NL-Enschede-MST
Enschede
NL-Gouda-GROENEHART
Gouda
NL-Groningen-UMCG
Groningen
NL-Heerlen-ATRIUMMC
Heerlen
NL-Helmond-ELKERLIEK
Helmond
NL-Nieuwegein-ANTONIUS
Nieuwegein
NL-Nijmegen-CWZ
Nijmegen
NL-Rotterdam-ERASMUSMC
Rotterdam
NL-Rotterdam-MAASSTADZIEKENHUIS
Rotterdam
NL-Sittard-Geleen-ZUYDERLAND
Sittard
NL-Sneek-ANTONIUSSNEEK
Sneek
NL-Den Haag-HAGA
The Hague
NL-Tilburg-ETZ
Tilburg
NL-Uden-BERNHOVEN
Uden
NL-Utrecht-UMCUTRECHT
Utrecht
NL-Zaandam-ZAANSMC
Zaandam
NL-Zwolle-ISALA
Zwolle
Denmark6 sites
DK-Aalborg-AALBORGUH
Aalborg
DK-Copenhagen-RIGSHOSPITALET
Copenhagen
DK-Herlev-HERLEV
Herlev
DK-Holstebro-HOLSTEBRO
Holstebro
DK-Odense-OUH
Odense
DK-Roskilde-ROSKILDE
Roskilde
Belgium5 sites
BE-Antwerpen-ZNASTUIVENBERG
Antwerp
BE-Brugge-AZBRUGGE
Bruges
BE-Bruxelles-STLUC
Brussels
BE-Haine-Saint-Paul-JOLIMONT
Haine-Saint-Paul
BE-Leuven-UZLEUVEN
Leuven
Finland5 sites
FI-Helsinki-HUS
Helsinki
FI-Jyvaskyla-KSSHP
Jyväskylä
FI-Kuopio-KYS
Kuopio
FI-Tampere-TAYS
Tampere
FI-Turku-TYKS
Turku
Sweden5 sites
SE-Boras-SASBORAS
Borås
SE-Linköping-REGIONOSTERGOTLAND
Linköping
SE-Luleå-SUNDERBY
Luleå
SE-Lund-SUH
Lund
SE-Uppsala-UPPSALAUH
Uppsala
About this study
The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15 induction cycles.
- Being tested
- Ibrutinib + Venetoclax 15 cycles, Ibrutinib until progression/relapse, Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibrutinib + Venetoclax 15 cyclesDrug
Cycle 1 + 2: 420 mg ibrutinib, day 1-28 | Cycle 3: 420 mg ibrutinib, day 1-28 | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | Cycle 4-15: 420 mg ibrutinib, day 1-28 + 400mg venetoclax, day 1-28
Ibrutinib until progression/relapseDrug
420mg ibrutinib daily until progression/relapse
Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cyclesDrug
Cycle 1: 420 mg ibrutinib | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | cycles 2-12: 420 mg ibrutinib, day 1-28 + 400 mg venetoclax, day 1-28
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib until progression/relapse | Experimental | All patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles.
MRDpositive patients (PB and BM) will continue on Ibrutinib maintenance (non-randomized group) until progression/relapse Receives: Drug: Ibrutinib + Venetoclax 15 cycles; Drug: Ibrutinib until progression/relapse |
| Arm A | Experimental | All patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles.
MRD negative patients (PB and BM) will be randomized to Arm A or Arm B. Arm A: Ibrutinib until progression/relapse (Continuous ibrutinib treatment until toxicity or progression) Receives: Drug: Ibrutinib + Venetoclax 15 cycles; Drug: Ibrutinib until progression/relapse |
| Arm B | Experimental | All patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles.
MRD negative patients (PB and BM) will be randomized to Arm A or Arm B. Arm B: Observation until event.
Patients randomized to Arm B will get reinitiation of therapy during the observation period in case of:
* progression according to IWCLL criteria or
* MRD≥10-3 (PB) and at least one month later MRD ≥10-2 (PB).
Treatment reinitiation will consist of ibrutinib and venetoclax (with ramp up of venetoclax from cycle 1) for 12 cycles Receives: Drug: Ibrutinib + Venetoclax 15 cycles; Drug: Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with progression free survival 27 months after starting treatment
arm B of the study
Measured: 27 months after last patient in trial
Secondary outcomes (10)
Number of patients with MRD negativity 27 months after starting treatment
all arms of the study
Measured: 27 months after last patient in trial
Number of patients with progression free survival
all arms of the study
Measured: 7 years after last patient in
Number of patients reinitiating treatment
arm B of the study
Measured: 7 years after last patient in
Number of patients with treatment failure after reinitiating treatment
arm B of the study
Measured: 7 years after last patient in
Number of patients initiating new CLL treatment
all arms of the study
Measured: 7 years after last patient in
Number of patients with MRD negativity 12 (peripheral blood) and 15 months (peripheral blood and bone marrow) after starting treatment
all arms of the study
Measured: 15 months after last patient in trial
Number of patients alive
all arms of the study
Measured: 7 years after last patient in
Number of patients with complete remission, partial remission and stable disease and the duration of remission for each group
all arms of the study
Measured: 7 years after last patient in
Number and grading of adverse events, serious adverse events and adverse events of special interest (bleeding, atrial fibrillation and tumorlysis)
all arms of the study
Measured: 7 years after last patient in
Number of patients with improved quality of life (by EORTC QLQ-C30 and QLQ-CLL16 questionnaires)
all arms of the study
Measured: 51 months after last patient in trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start23 Jun 2017
- Primary completion30 Jun 2021
- Study completion21 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles. Patients not achieving MRD negativity after cycle 12 (PB) AND/OR cycle 15 (PB+BM) continue on ibrutinib maintenance (non-randomized group). Patients achieving MRD negativity after cycle 12 (PB) AND cycle 15 (PB+BM) are randomized 1:2 between ibrutinib maintenance (arm A) and stopping treatment (observation, arm B).
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic CLL Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226301
- Sponsor's protocol ID
- HO141 CLL / VIsion trial
- Status last verified
- Aug 2022
- First submitted
- 15 May 2017
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niemann CU, Dubois J, Nasserinejad K, da Cunha-Bang C, Kersting S, Enggaard L, Veldhuis GJ, Mous R, Mellink CHM, van der Kevie-Kersemaekers AF, Dobber JA, Poulsen CB, Razawy W, Hollestein R, Frederiksen H, Janssens A, Schjodt I, Dompeling EC, Ranti J, Brieghel C, Mattsson M, Bellido M, Tran HTT, Kater AP, Levin MD. Long-term follow-up of MRD-guided ibrutinib plus venetoclax in relapsed CLL: phase 2 VISION/HO141 trial. Blood Adv. 2025 Aug 12;9(15):3665-3675. doi: 10.1182/bloodadvances.2024015180.
PubMed 40249856Kater AP, Levin MD, Dubois J, Kersting S, Enggaard L, Veldhuis GJ, Mous R, Mellink CHM, van der Kevie-Kersemaekers AF, Dobber JA, Poulsen CB, Frederiksen H, Janssens A, Schjodt I, Dompeling EC, Ranti J, Brieghel C, Mattsson M, Bellido M, Tran HTT, Nasserinejad K, Niemann CU. Minimal residual disease-guided stop and start of venetoclax plus ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia (HOVON141/VISION): primary analysis of an open-label, randomised, phase 2 trial. Lancet Oncol. 2022 Jun;23(6):818-828. doi: 10.1016/S1470-2045(22)00220-0.
PubMed 35654052Levin MD, Kater AP, Mattsson M, Kersting S, Ranti J, Thi Tuyet Tran H, Nasserinejad K, Niemann CU. Protocol description of the HOVON 141/VISION trial: a prospective, multicentre, randomised phase II trial of ibrutinib plus venetoclax in patients with creatinine clearance >/=30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations. BMJ Open. 2020 Oct 15;10(10):e039168. doi: 10.1136/bmjopen-2020-039168.
PubMed 33060089
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations
- ClinicalTrials.gov ID
- NCT03226301
- Acronym / sponsor ID
- HO141 CLL / VIsion trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen NederlandUniversity, hospital or other
- Collaborators
- Nordic CLL Study Group
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 21 Jun 2026 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients randomized to stopping treatment after 15 induction cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles. Patients not achieving MRD negativity after cycle 12 (PB) AND/OR cycle 15 (PB+BM) continue on ibrutinib maintenance (non-randomized group). Patients achieving MRD negativity after cycle 12 (PB) AND cycle 15 (PB+BM) are randomized 1:2 between ibrutinib maintenance (arm A) and stopping treatment (observation, arm B).
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib until progression/relapse | Experimental | Drug: Ibrutinib + Venetoclax 15 cycles, Drug: Ibrutinib until progression/relapseAll patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles. MRDpositive patients (PB and BM) will continue on Ibrutinib maintenance (non-randomized group) until progression/relapse |
| Arm A | Experimental | Drug: Ibrutinib + Venetoclax 15 cycles, Drug: Ibrutinib until progression/relapseAll patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles. MRD negative patients (PB and BM) will be randomized to Arm A or Arm B. Arm A: Ibrutinib until progression/relapse (Continuous ibrutinib treatment until toxicity or progression) |
| Arm B | Experimental | Drug: Ibrutinib + Venetoclax 15 cycles, Drug: Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cyclesAll patients receive ibrutinib + venetoclax (with delayed start and ramp up of venetoclax from cycle 3) for the 15 cycles. MRD negative patients (PB and BM) will be randomized to Arm A or Arm B. Arm B: Observation until event. Patients randomized to Arm B will get reinitiation of therapy during the observation period in case of: * progression according to IWCLL criteria or * MRD≥10-3 (PB) and at least one month later MRD ≥10-2 (PB). Treatment reinitiation will consist of ibrutinib and venetoclax (with ramp up of venetoclax from cycle 1) for 12 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Documented CLL or SLL requiring treatment according to IWCLL criteria after either being refractory to first line therapy or relapse after initial therapy.
Key exclusion criteria (15 listed)
- Any prior therapy with ibrutinib and/or venetoclax.
- Transformation of CLL (Richter's transformation).
- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML).
- Malignancies other than CLL currently requiring systemic therapies or not being treated in curative intention before or showing signs of progression after curative treatment.
- Known allergy to xanthine oxidase inhibitors and/or rasburicase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibrutinib + Venetoclax 15 cyclesCycle 1 + 2: 420 mg ibrutinib, day 1-28 | Cycle 3: 420 mg ibrutinib, day 1-28 | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | Cycle 4-15: 420 mg ibrutinib, day 1-28 + 400mg venetoclax, day 1-28 | Drug | Arm A, Arm B, Ibrutinib until progression/relapse |
| Ibrutinib until progression/relapse420mg ibrutinib daily until progression/relapse | Drug | Arm A, Ibrutinib until progression/relapse |
| Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cyclesCycle 1: 420 mg ibrutinib | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | cycles 2-12: 420 mg ibrutinib, day 1-28 + 400 mg venetoclax, day 1-28 | Drug | Arm B |
Primary outcome
Number of patients with progression free survival 27 months after starting treatment
Time frame: 27 months after last patient in trial
arm B of the study
10 secondary outcomes
Number of patients with MRD negativity 27 months after starting treatment
Time frame: 27 months after last patient in trial
Number of patients with progression free survival
Time frame: 7 years after last patient in
Number of patients reinitiating treatment
Time frame: 7 years after last patient in
Number of patients with treatment failure after reinitiating treatment
Time frame: 7 years after last patient in
Number of patients initiating new CLL treatment
Time frame: 7 years after last patient in
Number of patients with MRD negativity 12 (peripheral blood) and 15 months (peripheral blood and bone marrow) after starting treatment
Time frame: 15 months after last patient in trial
Number of patients alive
Time frame: 7 years after last patient in
Number of patients with complete remission, partial remission and stable disease and the duration of remission for each group
Time frame: 7 years after last patient in
Number and grading of adverse events, serious adverse events and adverse events of special interest (bleeding, atrial fibrillation and tumorlysis)
Time frame: 7 years after last patient in
Number of patients with improved quality of life (by EORTC QLQ-C30 and QLQ-CLL16 questionnaires)
Time frame: 51 months after last patient in trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 40249856Niemann CU, Dubois J, Nasserinejad K, da Cunha-Bang C, Kersting S, Enggaard L, Veldhuis GJ, Mous R, Mellink CHM, van der Kevie-Kersemaekers AF, Dobber JA, Poulsen CB, Razawy W, Hollestein R, Frederiksen H, Janssens A, Schjodt I, Dompeling EC, Ranti J, Brieghel C, Mattsson M, Bellido M, Tran HTT, Kater AP, Levin MD. Long-term follow-up of MRD-guided ibrutinib plus venetoclax in relapsed CLL: phase 2 VISION/HO141 trial. Blood Adv. 2025 Aug 12;9(15):3665-3675. doi: 10.1182/bloodadvances.2024015180.
- Derived from this study: PubMed 35654052Kater AP, Levin MD, Dubois J, Kersting S, Enggaard L, Veldhuis GJ, Mous R, Mellink CHM, van der Kevie-Kersemaekers AF, Dobber JA, Poulsen CB, Frederiksen H, Janssens A, Schjodt I, Dompeling EC, Ranti J, Brieghel C, Mattsson M, Bellido M, Tran HTT, Nasserinejad K, Niemann CU. Minimal residual disease-guided stop and start of venetoclax plus ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia (HOVON141/VISION): primary analysis of an open-label, randomised, phase 2 trial. Lancet Oncol. 2022 Jun;23(6):818-828. doi: 10.1016/S1470-2045(22)00220-0.
- Derived from this study: PubMed 33060089Levin MD, Kater AP, Mattsson M, Kersting S, Ranti J, Thi Tuyet Tran H, Nasserinejad K, Niemann CU. Protocol description of the HOVON 141/VISION trial: a prospective, multicentre, randomised phase II trial of ibrutinib plus venetoclax in patients with creatinine clearance >/=30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations. BMJ Open. 2020 Oct 15;10(10):e039168. doi: 10.1136/bmjopen-2020-039168.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib + Venetoclax 15 cycles, Ibrutinib until progression/relapse and Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles in people with Chronic Lymphocytic Leukemia in Relapse and Chronic Lymphocytic Leukemia in Remission, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 49 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Netherlands, Denmark, Belgium, Finland, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with progression free survival 27 months after starting treatment (time frame: 27 months after last patient in trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226301, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.