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New treatment option for Mantle Cell Lymphoma
Official title Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
ClinicalTrials.gov ID: NCT06263491
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as Rituxan.
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
- To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.
- 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. Healthy volunteers may be eligible.
You may be able to join if
- The study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment.
- Age ≥ 18 years old
- Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis...
- Newly diagnosed MCL with no prior therapy for MCL (age \>= 18 years)
- Low risk - Ki-67% (\<= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \<= 3 cm.
You likely can't join if
- Participants with central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal...
- High risk MCL - any or all of the following (Blastoid/pleomorphic histology), High Ki-67 (\>50%), Bulky disease (nodes \>5 cm, spleen \>20 cm)...
- Major surgery within 4 weeks prior to registration
- History of bleeding diathesis
- Known active CMV. Unknown or negative status are eligible
- Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or...
See the full eligibility criteria
Who can join
- The study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment.
- Age ≥ 18 years old
- Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC.
- Newly diagnosed MCL with no prior therapy for MCL (age \>= 18 years)
- Low risk - Ki-67% (\<= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \<= 3 cm.
- Medium risk - Ki-67% (\<=50%), largest tumor size \<=5 cm, no features of high-risk disease (see below in exclusion)
- Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, anti-hypertensive, prior ablation...
- Understand and voluntarily sign an IRB-approved informed consent form.
- Participants may have at least 1 site of radiographically assessable disease (i.e., lymph node longest diameter [LDi] \>= 1.5 cm, not necessary for disease assessable by positron emission tomography [PET]/computerized...
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (See Appendix III).
- Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (participants with an elevated prothrombin time and known lupus...
- Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
- Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Vasectomized partner
- Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual...
- Female sterilization
- Fallopian tube implants (if confirmed by hysterosalpingogram) 13. Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of Pirtobrutinib.
What rules you out
- Participants with central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML) are excluded since those participants have very poor...
- High risk MCL - any or all of the following (Blastoid/pleomorphic histology), High Ki-67 (\>50%), Bulky disease (nodes \>5 cm, spleen \>20 cm), lymphocytosis \>=50,000 cells/uL, TP53 mutated or del17p by FISH. Presence...
- Major surgery within 4 weeks prior to registration
- History of bleeding diathesis
- Known active CMV. Unknown or negative status are eligible
- Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other...
- Clinically significant cardiovascular diseases as determined after cardiology consultation, including uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of...
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel...
- Pregnancy or plan to become pregnant during the study or within 1-month post pirtobrutinib or 12 months post Rituxan. (Note: post rituxan, WOCBP should not become pregnant for 12 months post last dose of rituxan).
- Lactation during the study or for 1 week after last dose of pirtobrutinib (Note that the USPI for rituxan recommends no lactation during treatment and for 6 months after last dose)
- Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy...
- Participants taking warfarin and/or equivalent vitamin K antagonists
- Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.
- History of stroke or intracranial hemorrhage within 6 months of C1D1
- Vaccination with live vaccine within 28 days prior to enrollment.
- Have a known hypersensitivity to any of the excipients of Pirtobrutinib or rituximab
- Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially...
- Participants who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK-inhibitors. For patients with unknown HIV status, HIV testing will...
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below: Hepatitis B virus (HBV): Participants with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with...
- Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral including CMV, fungal or parasitic infection (except for fungal nail infection), or...
- Prolongation of the QT interval corrected for heart rate (QTcF) \> 470 msec on one electrocardiograms (ECGs), during Screening. EKG might be repeated same day to check for any physiologic variation. QTcF is calculated...
- Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug...
- Correction for underlying bundle branch block (BBB) allowed. Note: Participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.
- Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. people with adequately treated basal or squamous cell carcinoma of the skin, or adequately...
- Adequately treated no melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.
- Adequately treated cervical carcinoma in situ without current evidence of disease.
- Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy.
- Localized prostate cancer undergoing hormonal therapy.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel...
- With known allergies to xanthine oxidase inhibitors and/or rasburicase.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment...
- No concomitant anticancer therapies, immunotherapies, cellular, or radiotherapy. No major surgery within 4 weeks prior to first dose of study treatment.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) is for which...
- Concomitant steroids for disease related pain control are allowed at any dose but must be discontinued prior to any study treatment initiation. Chronic use of corticosteroids is allowed up to 20 mg prednisone or...
- History of GVHD, allogeneic HSCT transplant, allogeneic organ transplant
- Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, COPD, renal failure, active infection, active hemorrhage, laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.