Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03505944
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Nordic Lymphoma Group

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.

Condition or disease Intervention/treatment Phase
Relapsed Non Hodgkin Lymphoma Drug: Venetoclax Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Treatment
Venetoclax+lenalidomide+rituximab
Drug: Venetoclax
venetoclax + lenalidomide + rituximab




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505944


Contacts
Layout table for location contacts
Contact: Mats Jerkeman, MD +46 46177520 mats.jerkeman@med.lu.se

Locations
Layout table for location information
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Arne Kolstad       arnek@ous-hf.no   
Stavanger University Hospital Not yet recruiting
Stavanger, Norway
Contact: Idun Bakke Bo       idun.bakke.bo@sus.no   
St. Olav Hospital Recruiting
Trondheim, Norway
Contact: Karin Wader       karin.wader@stolav.no   
Sweden
Skane University Hospital Recruiting
Lund, Sweden
Contact: Mats Jerkeman, MD    +46 4617 7520    mats.jerkeman@med.lu.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Kristina Sonnevi       kristina.sonnevi@karolinska.se   
Uppsla Academic Hospital Recruiting
Uppsala, Sweden
Contact: Ingrid Glimelius       ingrid.glimelius@igp.uu.se   
Sponsors and Collaborators
Nordic Lymphoma Group

Layout table for additonal information
Responsible Party: Nordic Lymphoma Group
ClinicalTrials.gov Identifier: NCT03505944     History of Changes
Other Study ID Numbers: NLG-MCL7
2017-001060-38 ( EudraCT Number )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Venetoclax
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors