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New treatment option for Recurrent Mantle Cell Lymphoma
Official title Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT05910801
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent mantle cell lymphoma.
Also referred to as CC-5013, CC5013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 or refractory disease, which is defined as patients with \>= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or...
- 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...
You likely can't join 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...
- Men or women of reproductive potential who are unwilling to employ adequate contraception during treatment and for 4 weeks after last dose of...
- Any of the following prior therapies:
- Autologous stem cell transplant =\< 90 days prior to registration
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- Grapefruit or grapefruit products
- Seville oranges or products from Seville oranges
- Star fruit
- Human Immunodeficiency Virus (HIV) positive. All people will be screened for HIV =\< 14 days prior to registration
- Patient with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. All people will be screened for hepatitis B and hepatitis C =\< 14 days prior to registration NOTE: Patients with positive hepatitis...
- 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...
- 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...
- Unable to swallow oral drugs
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.