NCT03505944

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1

Geographic Reach
4 countries

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

4.4 years

First QC Date

April 13, 2018

Last Update Submit

October 12, 2021

Conditions

Relapsed Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Venetoclax+lenalidomide+rituximab

Drug: Venetoclax

Interventions

VenetoclaxDRUG

venetoclax + lenalidomide + rituximab

Treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +4 more criteria

You may not qualify if:

  • Chemotherapy or radiotherapy within 3 weeks
  • Therapeutic antibodies or BTK inhibitors within 4 weeks
  • Radioimmunotherapy within 10 weeks
  • Previous treatment with venetoclax
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Department of Hematology Aalborg University Hospital

Aalborg, Denmark

Location

Department of Hematology Aarhus University Hospital

Aarhus, Denmark

Location

Clinic of Hematology L-4241 Rigshospitalet

Copenhagen, Denmark

Location

Department of Hematology X Odense University Hospital

Odense, Denmark

Location

Hæmatologisk Afdeling Zeeland University Hospital, Roskilde

Roskilde, Denmark

Location

Department of Hematology Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Oslo University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olav Hospital

Trondheim, Norway

Location

Department of Hematology Linköping University Hospital

Linköping, Sweden

Location

Department of Medicine Sunderbyn Hospital

Luleå, Sweden

Location

Skane University Hospital

Lund, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Department of Oncology Norrland University Hospital

Umeå, Sweden

Location

Uppsla Academic Hospital

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 38113470DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

venetoclax

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mats Jerkeman

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 23, 2018

Study Start

July 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 13, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(6)FI(3)NO(3)DK(5)