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New treatment option for Grade 3b Follicular Lymphoma
Official title Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
ClinicalTrials.gov ID: NCT05890352
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 grade 3b follicular 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 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Participants must have:
- Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines
- Follicular lymphoma, grade 3B
- Transformed lymphoma
- High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements
You likely can't join if
- Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not...
- Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative...
- Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute leukemia (T-ALL). Testing is not required for...
- Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT...
- Participants must not have received prior treatment with tafasitamab and/or lenalidomide
- Participants must not have had prior BTK inhibitor or tazemetostat
See the full eligibility criteria
Who can join
- Participants must have:
- Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines
- Follicular lymphoma, grade 3B
- Transformed lymphoma
- High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements
- Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality...
- Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.
- Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma
- Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy
- Steroid use for the control of non-Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to Cycle 1, Day 1
- Participant must be \>= 18 years old
- Participant must have Zubrod Performance Status of 0-3
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration)
- If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Absolute neutrophil count (ANC) \>= 0.75 x 10\^3/uL
- Platelets \>= 75 x 10\^3/uL (within 28 days prior to registration)
- If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Platelets \>= 50 x 10\^3/uL
- Aspartate aminotransferase (AST) =\< 3 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =\< 3 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or...
- Participants with lymphomatous involvement of the liver must have AST =\< 5 x IULN, ALT =\< 5 x IULN
- Total bilirubin =\< 1.5 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.
- Participants with lymphomatous involvement of the liver must have total bilirubin =\< 5 x IULN
- Participants must have a calculated creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Participants must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6...
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy
- Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent...
- Participants must be able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or...
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- Participants who can complete the FACT-Lym and PRO-CTCAE forms in English or Spanish must agree to participate in the patient-reported outcome study
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and...
What rules you out
- Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not effective to sufficiently penetrate the blood brain barrier
- Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and...
- Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute leukemia (T-ALL). Testing is not required for eligibility determination
- Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or...
- Participants must not have received prior treatment with tafasitamab and/or lenalidomide
- Participants must not have had prior BTK inhibitor or tazemetostat
- Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib
- Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration
- Notes: Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or how well it works assessment of...
- Participants must not be pregnant or nursing and must follow the guidelines according to the lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program. The effects of tazemetostat, zanubrutinib, lenalidomide...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Duarte, California, United States
- Huntington Beach, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
- Fort Lauderdale, Florida, United States
- Miami Beach, Florida, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- New Lenox, Illinois, United States
- Orland Park, Illinois, United States
- Shiloh, Illinois, United States
+ 64 more site(s).
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 Tucson, Arizona, United States; Beverly Hills, California, United States; Duarte, California, United States; Huntington Beach, California, United States; Lancaster, California, United States; Long Beach, California, United States and 78 more location(s). 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.