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Recurrent Mantle Cell LymphomaPhase 2V-MINDNCT05910801

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

A Phase 2 study testing Biopsy, Biospecimen Collection and Bone Marrow Aspiration in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by Academic and Community Cancer Research United at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Biospecimen Collection and Bone Marrow Aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
4 Jan 2024to 30 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age >= 18 years old
  • Confirmed pathology diagnosis of mantle cell lymphoma (MCL) with t(11;14)(q13;q32) translocation or cyclin D1 overexpression NOTE: Patients with relapsed/refractory MCL after prior anti-CD19 therapy (such as chimeric antigen receptor [CAR] T-cell therapy) should have confirmed preserved expression of CD19, unless a biopsy is not feasible or associated with a high risk of complications in the treating physician's opinion
  • Relapsed or refractory disease, which is defined as patients with >= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or venetoclax is allowed, provided there was no disease progression on lenalidomide or venetoclax
  • In the view of the treating physician, the patient is in need of treatment, for example, with lymphoma-related symptoms or cytopenia
  • Evaluable disease, which is defined as at least one lymph node or other type of lesion that has a size >= 1.5 cm, or spleen size >= 15 cm or white blood cell (WBC) >= 30,000/mm^3 in leukemic non-nodal MCL patients
  • Eastern Cooperative Oncology Group Performance Status (PS) 0, 1, or 2
Show all 21Show fewer
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration)
  • Platelet count >= 75,000/mm^3 (>= 50,000/mm^3 if there is evidence of bone marrow involvement by MCL or hypersplenism) (obtained =< 14 days prior to registration)
  • Hemoglobin > 8.0 g/dL (obtained =< 14 days prior to registration)
  • Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =< 1.5 × upper normal limit (ULN) (obtained =< 14 days prior to registration)
  • Prothrombin (PT) or international normalized ratio (INR) =< 1.5 × upper normal limit (ULN) (obtained =< 14 days prior to registration)
  • Total bilirubin =< 1.5 × ULN (or =< 3 × ULN if there is evidence of parenchymal liver involvement with MCL or documented Gilbert's disease) (obtained =< 14 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 × ULN (or =< 5 × ULN if there is evidence of parenchymal liver involvement with MCL) (obtained =< 14 days prior to registration)
  • Calculated creatinine clearance > 60 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
  • Negative pregnancy test done =< 7 days prior to registration, for women of reproductive potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required NOTE: Females of reproductive potential include all females who are menstruating, amenorrheic from previous medical treatments, under 50 years of age, and/or perimenopausal, and do not qualify for the females not of reproductive potential category. Females not of reproductive potential include females who have been in natural menopause for at least 24 consecutive months, or who have had a hysterectomy and/or bilateral oophorectomy, or female children who have not started menstruating
  • Agree to use effective contraception during study treatment and for 4 weeks after last dose of lenalidomide and for 3 months after last dose of tafasitamab (whichever is longer) Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control simultaneously: one highly effective form of contraception - tubal ligation, intrauterine device (IUD), hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and one additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Contraception should continue during therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. If needed, females of reproductive potential should be referred to a qualified provider of contraceptive methods Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential during trial therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer), even if they have undergone a successful vasectomy. Male patients must not donate sperm
  • Willing to be registered into the mandatory REVLIMID REMS (trademark) program, and willing and able to comply with the requirements of the REVLIMID REMS program
  • Able to take low-dose aspirin (81 mg) daily or an alternative form of anticoagulation
  • Subject must voluntarily sign and date an informed consent =< 28 days prior to registration
  • Willing to return to enrolling institution for follow-up during the active monitoring phase (i.e., active treatment and clinical follow-up) of the study
  • Willing to provide mandatory blood specimens for correlative research and banking for future correlative research pertinent to this study

Who cannot join

  • Any of the following:
  • Pregnant persons
  • Nursing persons (lactating persons are eligible provided that they agree not to use their breast milk to feed while receiving treatment on the study or within 3 months of the last dose of study treatment)
  • Men or women of reproductive potential who are unwilling to employ adequate contraception during treatment and for 4 weeks after last dose of lenalidomide or for 3 months after last dose of tafasitamab (whichever is longer)
  • Any of the following prior therapies:
  • Autologous stem cell transplant =< 90 days prior to registration
Show all 41Show fewer
  • Allogeneic stem cell transplant
  • Anti-CD19 CAR T-cell therapy =< 90 days prior to registration
  • Any central nervous system (CNS) involvement by MCL (e.g., any parenchymal, leptomeningeal, cerebrospinal fluid [CSF], cranial or spinal nerve root involvement)
  • Receiving any other treatment which would be considered as a treatment for MCL (with the exception of corticosteroid). If a patient received recent MCL treatment prior to registration, at least 5 half-lives of the drug(s) OR 14 days must have passed following the last dose for the patient to be eligible
  • Any of the following medication requirement or recent use:
  • Anticoagulation with a vitamin K antagonist =< 7 days prior to registration
  • Requirement of a P-gp inhibitor during the study
  • Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer during the study
  • Use of a strong or moderate CYP3A inhibitor or inducer =< 7 days prior to registration
  • NOTE: Because of their effect on CYP3A4, use of any of the following within 3 days of registration or planned use during study participation is prohibited:
  • Grapefruit or grapefruit products
  • Seville oranges or products from Seville oranges
  • Star fruit
  • Human Immunodeficiency Virus (HIV) positive. All subjects will be screened for HIV =< 14 days prior to registration
  • Patient with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. All subjects will be screened for hepatitis B and hepatitis C =< 14 days prior to registration NOTE: Patients with positive hepatitis B surface antigen (HBsAg) are excluded from participation in this trial. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded from participating in this trial NOTE: Patients with positive hepatitis C antibody need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded from participating in this trial
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the local investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness, in the judgement of the local investigator, including, but not limited to:
  • New York Heart Association (NYHA) class III or IV or symptomatic congestive heart failure
  • Unstable angina or acute coronary syndrome =< 3 months prior to registration
  • Uncontrolled or symptomatic cardiac arrhythmia
  • NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
  • Oxygen dependent baseline lung disease (such as interstitial lung disease or chronic obstructive pulmonary disease [COPD])
  • Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment
  • Ongoing malabsorption syndrome or other condition that precludes enteral route of administration
  • Ongoing or active infection (viral, bacterial, or fungal)
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • History of the following:
  • Cerebral vascular accident within 24 weeks prior to registration
  • Myocardial infarction within 24 weeks prior to registration
  • Major surgery =< 28 days prior to registration
  • Live vaccination =< 28 days prior to registration
  • Life-threatening thrombosis/embolism
  • Bleeding diathesis that precludes the use of low-dose aspirin (81 mg daily) or any form of anticoagulation
  • Other active primary malignancy (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years NOTE: If there is a history of prior malignancy, the patient must be in remission not require ongoing therapy such as radiation, chemotherapy or immunotherapy for their cancer. Patients on adjuvant hormonal therapy for adequately treated nonmetastatic breast or prostate cancer are permitted if they meet other eligibility criteria
  • Unable to swallow oral drugs

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Inbox Mayo Clinic Cancer Studies contact

507-538-5424

MAYOCLINICCANCERSTUDIES@mayo.edu

United States2 sites, 2 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Debbie Stroughter, 713-792-7734, CR_Study_Registration@mdanderson.org

    Michael Wang

    Not yet recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    ACCRU Operations, 507-538-6647, accru@mayo.edu

    Yucai Wang

    Recruiting

Other trials in United States

About this study

Official title: Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): a Phase II Study with Safety Lead-In

This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab, lenalidomide and venetoclax together may kill cancer cells more efficiently in patients with relapsed or refractory mantle cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the overall response rate in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

SECONDARY OBJECTIVES:

  1. To estimate the complete response rate in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

II. To estimate the duration of response (DoR) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

III. To estimate the progression free survival (PFS) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

IV. To estimate the overall survival (OS) in patients with relapsed/refractory mantle cell lymphoma after treatment with tafasitamab, lenalidomide and venetoclax combination.

  1. To evaluate the safety profile of tafasitamab, lenalidomide and venetoclax combination in patients with relapsed/refractory mantle cell lymphoma.

CORRELATIVE OBJECTIVES:

  1. To assess the rate of undetectable minimal residual disease (uMRD) in peripheral blood by multi-color flow cytometry.

II. To assess the correlation between MRD status with clinical outcomes such as DoR, PFS and OS.

OUTLINE: Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO) and venetoclax PO while on study. Patients may undergo lumbar puncture during screening. Patients undergo computed tomography (CT) scan and blood sample collection and may undergo magnetic resonance imaging (MRI) and tumor biopsy on study and during follow-up. Patients undergo positron emission tomography (PET)/CT, bone marrow biopsy, and bone marrow aspirate throughout the study.

After treatment completion, patients follow up every 3 months for 1 year, every 4 months for 1 year and then every 6 months until up to 5 years after entering the trial.

Being tested
Biopsy, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Lumbar PunctureProcedure or surgery

    Also called LP, Spinal Tap

    Undergo lumbar puncture

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT scan

  • TafasitamabBiological

    Also called Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208

    Given IV

  • VenetoclaxDrug

    Also called ABT-0199, ABT-199, ABT199, GDC-0199

    Given PO

Study groups in NCT05910801
Study groupRoleWhat they receive
Treatment (Tafasitamab, lenalidomide, venetoclax)ExperimentalPatients receive tafasitamab IV, lenalidomide PO and venetoclax PO while on study. Patients may undergo lumbar puncture during screening. Patients undergo CT scan and blood sample collection and may undergo MRI and tumor biopsy on study and during follow-up. Patients undergo PET/CT, bone marrow biopsy, and bone marrow aspirate throughout the study.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Biological: Tafasitamab; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    A response is defined to be either a partial metabolic response (PMR) or complete metabolic response (CMR) by positron emission tomography (PET) or a partial response (PR) or complete response (CR) by computed tomography (CT) noted as the objective status using Lugano criteria. Objective response rate is defined as the proportion of evaluable patients who achieve response while on treatment. Estimate and corresponding 95% confidence intervals will be calculated according to the approach of Duffy and Santner.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Complete response rate

    Will be estimated for each cohort by the total number of patients who achieve a CMR (by PET/CT) or CR (by CT) at any time on treatment divided by the total number of evaluable patients. Point estimate for complete response rate and corresponding 95% confidence interval will be provided using exact method.

    Measured: Up to 5 years

  2. Duration of response

    Will be estimated using the method of Kaplan-Meier separately for each cohort.

    Measured: From first documentation of objective status(PMR or CMR by PET/CT, or PR or CR by CT) to the earliest date of progression or death, assessed up to 5 years

  3. Progression free survival

    Will be estimated using method of Kaplan-Meier separately for each cohort.

    Measured: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years

  4. Overall survival

    Will be estimated using method of Kaplan-Meier for each cohort.

    Measured: From registration to death due to any cause, assessed up to 5 years

  5. Incidence of adverse events (AE)

    The maximum grade for each type of AE from each patient will be used for analysis, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration. Adverse events will be reported separately for each cohort.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2023
  2. Study start4 Jan 2024
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05910801
Sponsor's protocol ID
ACCRU-LY-2101
Other IDs
NCI-2023-03968, ACCRU-LY-2101, P30CA015083
Acronym
V-MIND
Status last verified
Nov 2024
First submitted
9 Jun 2023
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy, Biospecimen Collection and Bone Marrow Aspiration in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by Academic and Community Cancer Research United at 2 sites in United States.

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 21 inclusion and 41 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Inbox Mayo Clinic Cancer Studies (507-538-5424, MAYOCLINICCANCERSTUDIES@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Up to 5 years). 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 NCT05910801.

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 18 Nov 2024.

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