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Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma (VALERIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03505944
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : September 10, 2020
Information provided by (Responsible Party):
Nordic Lymphoma Group

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Official Title  ICMJE Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed Non Hodgkin Lymphoma
Intervention  ICMJE Drug: Venetoclax
venetoclax + lenalidomide + rituximab
Study Arms  ICMJE Experimental: Treatment
Intervention: Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mats Jerkeman, MD +46 46177520
Listed Location Countries  ICMJE Denmark,   Finland,   Norway,   Sweden
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03505944
Other Study ID Numbers  ICMJE NLG-MCL7
2017-001060-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nordic Lymphoma Group
Study Sponsor  ICMJE Nordic Lymphoma Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mats Jerkeman Skane University Hospital
PRS Account Nordic Lymphoma Group
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP