Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
V-MIND
3 other identifiers
interventional
100
1 country
2
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2024
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 20, 2023
CompletedStudy Start
First participant enrolled
January 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
November 18, 2024
November 1, 2024
6 years
June 9, 2023
November 14, 2024
Conditions
Outcome Measures
Primary Outcomes (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.
Up to 5 years
Secondary Outcomes (5)
Complete response rate
Up to 5 years
Duration of response
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
Progression free survival
From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
Overall survival
From registration to death due to any cause, assessed up to 5 years
Incidence of adverse events (AE)
Up to 5 years
Study Arms (1)
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.
Interventions
Undergo biopsy
Undergo blood sample collection
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo CT scan
Given PO
Undergo lumbar puncture
Undergo MRI
Undergo PET/CT scan
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- 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
- 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
- +6 more criteria
You may not qualify if:
- 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
- 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
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yucai Wang
Academic and Community Cancer Research United
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2023
First Posted
June 20, 2023
Study Start
January 4, 2024
Primary Completion (Estimated)
December 30, 2029
Study Completion (Estimated)
December 30, 2030
Last Updated
November 18, 2024
Record last verified: 2024-11