Relapsed Non Hodgkin LymphomaPhase 1/2VALERIANCT03505944
Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
A Phase 1/2 study testing Venetoclax in people with Relapsed Non Hodgkin Lymphoma, run by Nordic Lymphoma Group at 17 sites in 4 countries.
Trial summary
Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Relapsed Non Hodgkin Lymphoma
- What is being tested?
- Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 1 Jul 2018to 1 Dec 2022
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Histologically confirmed (according to the WHO 2016 classification) mantle cell lymphoma stage I-IV
- Who have received at least 1 prior rituximab-containing chemotherapy regimen, with documented relapse or disease progression following the last anti-MCL treatment OR
- Are not considered to be candidates for chemotherapy due to frailty or comorbidity
- At least 1 measurable site of disease (>1.5 cm long axis)
- WHO performance status 0 - 3
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- Written informed consent.
- Female subjects of childbearing potential must (see page 52 for definition of not fertile):
- Understand that the study medication is expected to be teratogenic
- Agree to use, and be able to comply with, highly effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea.
- All fertile women must agree to perform monthly pregnancy tests while on study medication and until 4 weeks after completion of study drug. Tests must have a minimum sensitivity of 25 mIE/ml and be medically witnessed
- Highly effective contraception include:
- Implant Levonorgestrel-releasing intrauterine system (IUS) Medroxyprogesterone acetate depot Tubal sterilisation Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel) NB! Patients using a hormonal method, must also use a second barrier method. Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject).
- Male subjects must
- Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- All subjects must
- Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused study drug to the investigator
Who cannot join
- Chemotherapy or radiotherapy within 3 weeks
- Therapeutic antibodies or BTK inhibitors within 4 weeks
- Radioimmunotherapy within 10 weeks
- Major surgery within 4 weeks of inclusion in this trial.
- Previous treatment with venetoclax
- Impaired liver function: AST and ALT >3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin > 1.5 × ULN. Subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN, per discussion between the investigator and medical monitor. Elevated Bilirubin due to haemolytic anemia or caused by lymphoma, is not an exclusion criterion.
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- Absolute neutrophil count (ANC) <1.0x 109, unless caused by bone marrow infiltration by lymphoma.
- Platelet count <60 x 109, unless caused by bone marrow infiltration by lymphoma.
- Creatinine clearance below 50 ml/min (Cockcroft-Gault)
- Known CNS lymphoma.
- Heart failure in NYHA stage IV or other serious CVD
- Pulmonary failure (ex chronic disease with hypoxemia)
- Active serious infections such as hepatitis B or C and HIV
- Conditions with serious immunocompromised state
- Breastfeeding women must be excluded or stop breastfeeding
- Other active malignancy.
- Psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
- Requirement of corticosteroid therapy at a dose >10 mg prednisolone/day.
- Hypersensitivity to venetoclax, lenalidomide or rituximab, or HACA against rituximab.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Sweden6 sites
Department of Hematology Linköping University Hospital
Linköping
Department of Medicine Sunderbyn Hospital
Luleå
Skane University Hospital
Lund
Karolinska University Hospital
Stockholm
Department of Oncology Norrland University Hospital
Umeå
Uppsla Academic Hospital
Uppsala
Denmark5 sites
Department of Hematology Aalborg University Hospital
Aalborg
Department of Hematology Aarhus University Hospital
Aarhus
Clinic of Hematology L-4241 Rigshospitalet
Copenhagen
Department of Hematology X Odense University Hospital
Odense
Hæmatologisk Afdeling Zeeland University Hospital, Roskilde
Roskilde
Finland3 sites
Department of Hematology Helsinki University Hospital Comprehensive Cancer Center
Helsinki
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Norway3 sites
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
St. Olav Hospital
Trondheim
About this study
Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL.
- Conditions
- Relapsed Non Hodgkin Lymphoma
- Being tested
- Venetoclax
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
venetoclax + lenalidomide + rituximab
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Venetoclax+lenalidomide+rituximab Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed Non Hodgkin LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Lymphoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mats Jerkeman, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505944
- Sponsor's protocol ID
- NLG-MCL7
- Other IDs
- 2017-001060-38, 2017
- Acronym
- VALERIA
- Status last verified
- Oct 2021
- First submitted
- 13 Apr 2018
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jerkeman M, Kolstad A, Hutchings M, Pasanen A, Meriranta L, Niemann CU, Kragh Jorgensen RR, El-Galaly TC, Riise J, Leppa S, Christensen JH, Sonnevi K, Pedersen LB, Wader KF, Glimelius I. MRD-driven treatment with venetoclax-R2 in mantle cell lymphoma: the Nordic Lymphoma Group MCL7 VALERIA trial. Blood Adv. 2024 Jan 23;8(2):407-415. doi: 10.1182/bloodadvances.2023011920.
PubMed 38113470
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03505944
- Acronym / sponsor ID
- VALERIA / NLG-MCL7
- Conditions
- Relapsed Non Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Nordic Lymphoma GroupResearch network
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Apr 2018 (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.
Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of rituximab-lenalidomide in patients with relapsed/refractory MCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: VenetoclaxVenetoclax+lenalidomide+rituximab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age >18 years
- Histologically confirmed (according to the WHO 2016 classification) mantle cell lymphoma stage I-IV
- At least 1 measurable site of disease (>1.5 cm long axis)
- WHO performance status 0 - 3
- Written informed consent.
Key exclusion criteria (19 listed)
- Chemotherapy or radiotherapy within 3 weeks
- Therapeutic antibodies or BTK inhibitors within 4 weeks
- Radioimmunotherapy within 10 weeks
- Major surgery within 4 weeks of inclusion in this trial.
- Previous treatment with venetoclax
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 |
|---|---|---|
| Venetoclaxvenetoclax + lenalidomide + rituximab | Drug | Treatment |
Primary outcome
Overall response rate
Time frame: 6 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 38113470Jerkeman M, Kolstad A, Hutchings M, Pasanen A, Meriranta L, Niemann CU, Kragh Jorgensen RR, El-Galaly TC, Riise J, Leppa S, Christensen JH, Sonnevi K, Pedersen LB, Wader KF, Glimelius I. MRD-driven treatment with venetoclax-R2 in mantle cell lymphoma: the Nordic Lymphoma Group MCL7 VALERIA trial. Blood Adv. 2024 Jan 23;8(2):407-415. doi: 10.1182/bloodadvances.2023011920.
- 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.
Mats Jerkeman principal investigator
Skane University Hospital
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Venetoclax in people with Relapsed Non Hodgkin Lymphoma, run by Nordic Lymphoma Group at 17 sites in 4 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 19 inclusion and 19 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden, Denmark, Finland, Norway. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall response rate (time frame: 6 months). 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 NCT03505944, which also lists 1 linked publication.
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 13 Oct 2021.