Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 7/17/23. Questions regarding updates should be directed to the study team contact.