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Mantle Cell LymphomaPhase 2NCT06522386

GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

A Phase 2 study testing Pirtobrutinib, Rituximab and Venetoclax in people with Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Pirtobrutinib, Rituximab and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
30 Jan 2025to 28 Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old.
  • Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression (e.g., positive immunohistochemistry staining).
  • MCL cells are CD20 positive (e.g., positive staining on immunohistochemistry or flow cytometry).
  • No prior MCL-directed systemic treatment (such as chemotherapy, immunotherapy, targeted therapy, and cellular therapy) or radiotherapy.
  • NOTE: A short course of corticosteroids (e.g., ≤ 1 week of intravenous or ≤ 2 weeks of oral) given for acute MCL-related symptoms or impending severe organ dysfunction is allowed, but a washout period of 3 days is required before registration.
  • Have a clinical indication to treat (e.g., B symptoms, or symptomatic or progressive lymphadenopathy or hepatosplenomegaly, or cytopenia caused by MCL, etc.).
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  • ECOG performance status (PS) 0-2 (Appendix I).
  • Evaluable disease, i.e., ANY of the following:
  • Measurable lymph node or extranodal lesion with at least one dimeson > 1.5 cm
  • Spleen size > 15 cm if spleen is involved by MCL (based on imaging or biopsy)
  • WBC > 15,000/µL if peripheral blood is involved by MCL (based on flow cytometry)
  • Bone marrow involvement by MCL (> 10% of cellularity)
  • Endoscopically visible lesion that is biopsy-proven to be involved by MCL
  • Meet ALL following criteria in lab values obtained ≤ 14 days prior to registration:
  • Absolute neutrophil count (ANC) ≥ 1000/µL without growth factor support
  • Platelet count ≥ 75,000/µL without transfusion support (≥ 50,000/µL if there is evidence of bone marrow involvement by MCL or splenomegaly due to MCL)
  • Hemoglobin ≥ 8.0 g/dL without transfusion support
  • Prothrombin (PT) or international normalized ratio (INR) ≤ 1.5 × upper normal limit (ULN)
  • Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN
  • Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN if there is evidence of parenchymal liver involvement by MCL; patients with Gilbert's syndrome or hemolysis are eligible if direct bilirubin is ≤ 1.5 × ULN
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN, or ≤ 5 × ULN if there is evidence of parenchymal liver involvement by MCL
  • Creatinine clearance > 50 mL/min using the Cockcroft-Gault formula (Appendix II)
  • Left ventricular ejection fraction by ECHO or MUGA ≥ 50% (must be within 12 months prior to registration).
  • Able to understand and voluntarily sign an IRB-approved informed consent form.
  • Willing to provide mandatory research blood, bone marrow, lymphoma biopsy tissue, and saliva specimens for correlative research.
  • Willing to return to enrolling institution for follow-up.
  • Negative serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential, defined as post menarche and not postmenopausal (i.e., ≥ 2 years of non-therapy-induced amenorrhea) or surgically sterile (e.g., post-hysterectomy, bilateral salpingectomy, or oophorectomy).
  • Persons of reproductive potential and their partners must agree to use highly effective birth control methods for the duration of study treatment and for 1 month (30 days) following the last dose of pirtobrutinib and/or venetoclax and for 12 months following the last dose of rituximab (Appendix III).
  • Males must agree to not donate sperms for the duration of study treatment and for 3 months following the last dose of any study drug.

Who cannot join

  • CNS involvement by MCL (e.g., any parenchymal, leptomeningeal, CSF, cranial nerve, or spinal cord or nerve root involvement).
  • Pregnant or plan to become pregnant during study treatment or within 1 month following the last dose of pirtobrutinib and/or venetoclax or within 12 months following the last dose of rituximab; or breast-feeding or plan to breastfeed during study treatment or within 1 week following the last dose of pirtobrutinib and/or venetoclax or within 6 months following the last dose of rituximab.
  • Malabsorption syndrome or other condition that precludes enteral route of administration.
  • Any of the following medication requirement or recent use:
  • Use of a strong or moderate cytochrome P450 (CYP) 3A inhibitor or inducer ≤ 7 days prior to registration
  • Anticipated requirement of a strong CYP3A inhibitor or inducer during the study that cannot be substituted
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  • Use of grapefruit or grapefruit products, Seville oranges or products from Seville oranges, or star fruit ≤ 3 days prior to registration, or planned use during the study
  • Anticipated requirement of a strong P-gp inhibitor during the study
  • Anticoagulation with a vitamin K antagonist ≤ 7 days prior to registration or anticipated use during the study
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the 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.
  • History of a bleeding disorder (e.g., hemophilia, von Willebrand disease, etc.) or active bleeding.
  • Active or recent infections, including but not limited to:
  • Active infections requiring treatment (such as systemic antibiotics, antivirals, or antifungals) ≤ 7 days prior to registration
  • History of a positive COVID-19 (SARS-CoV-2) test (nucleic acid or antigen) within 4 weeks prior to registration, or presence of continued COVID-19-related clinically relevant symptoms or COVID-19-related significant pulmonary infiltrates in patients with a history of COVID-19 disease
  • Human Immunodeficiency Virus (HIV) positive NOTE: Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to potential drug-drug interactions between anti-retroviral medications and pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for the patient to be eligible.
  • Known active Cytomegalovirus (CMV) infection
  • Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require HBV polymerase chain reaction (PCR) evaluation. Patients who are HBV PCR positive will be excluded. Due to rituximab's black box warning for Hepatitis B reactivation, patients with positive hepatitis B core antibody (anti-HBc) should have prophylactic therapy with an approved nucleos(t)ide analogue to prevent reactivation.
  • Hepatitis C virus (HCV): If hepatitis C antibody result is positive, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded.
  • Uncontrolled cardiovascular disease including but not limited to:
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 110 mmHg despite of 3 different classes of full dose anti-hypertensives medications) History of myocardial infarction ≤ 3 months prior to registration Unstable angina or acute coronary syndrome ≤ 2 months prior to registration New York Heart Association (NYHA) Class III or IV or symptomatic congestive heart failure or dilated cardiomyopathy Uncontrolled or symptomatic arrhythmias NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
  • Prolongation of QT interval corrected for heart rate (QTcF, calculated using Fridericia's Formula: QTcF=QT/∛RR) > 470 msec.
  • NOTE: Correction for widened QRS complex (e.g., with pacing, or underlying bundle branch block, etc) allowed (e.g., "Adjusted QTcF" = measured QTcF - [measured QRS - 90 ms]). 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 not known to be associated with QTcF prolongation.
  • History of cerebral vascular accident ≤ 6 months prior to registration.
  • Oxygen dependent lung disease (such as interstitial lung disease or COPD).
  • Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Major surgery ≤ 28 days prior to registration.
  • Vaccination with a live vaccine ≤ 28 days prior to registration.
  • Another primary malignancy (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix or breast) that is not in remission or requires ongoing treatment (except for adjuvant hormonal therapy for adequately treated nonmetastatic breast or prostate cancer), or limits expected survival to ≤ 3 years.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55902

Other trials in United States

About this study

Primary Objectives:

To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

Read the detailed description

Secondary Objectives:

  • To evaluate the objective response rate to PRV combination therapy in patients with previously untreated MCL.
  • To evaluate the duration of response in patients with an objective response to PRV combination therapy.
  • To evaluate the progression-free survival and overall survival in patients treated with PRV combination therapy.
  • To evaluate the safety profile of PRV combination therapy in patients with previously untreated MCL.
Being tested
Pirtobrutinib, Rituximab, Venetoclax
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Given by mouth

  • RituximabDrug

    Also called Rituxan

    Given by vein (IV)

  • VenetoclaxDrug

    Also called ABT-199, GDC-0199

    Given by mouth

Study groups in NCT06522386
Study groupRoleWhat they receive
Pirtobrutinib, Rituximab and Venetoclax combinationExperimentalNot described
Receives: Drug: Pirtobrutinib; Drug: Rituximab; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start30 Jan 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522386
Sponsor's protocol ID
2024-0220
Other IDs
NCI-2024-06175
Status last verified
Oct 2026
First submitted
22 Jul 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirtobrutinib, Rituximab and Venetoclax in people with Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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