Recruiting PHASE1 Recurrent Mantle Cell Lymphoma

New treatment option for Recurrent Mantle Cell Lymphoma

Official title Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

ClinicalTrials.gov ID: NCT06675123

What this study is testing

What is BTK Inhibitor?

BTK Inhibitor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent mantle cell lymphoma.

Also referred to as Tyrosine-Protein Kinase BTK Protein.

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 I trial tests the safety and side effects of pacritinib in combination with a Bruton's tyrosine kinase (BTK) inhibitor and how well it works 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). Pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase 1: an early, usually small safety study

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

Documented informed consent of the participant and/or legally authorized representative
Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy...
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2

You likely can't join if

Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy
Prior allogeneic stem cell transplant
Prior treatment with pacritinib or a janus kinase 2 (JAK2) inhibitor
Concomitant treatment with pirtobrutinib
Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy
Note: Shorter washout periods may be permitted with approval of the study PI, provided that the washout period is at least five half-lives of the...

See the full eligibility criteria

Who can join

Documented informed consent of the participant and/or legally authorized representative
Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification with a characteristic immunophenotypic profile with CD5+, CD20+, and with either cyclin D1...
Relapsed or refractory disease after at least 1 prior line of systemic therapy
Relapse must have been confirmed histologically with hematopathology review. Exceptions may be granted with study PI approval
Patient must be receiving treatment with single agent ibrutinib or another covalent BTK inhibitor (e.g., acalabrutinib, zanubrutinib), and must have previously achieved complete response (CR) or partial response (PR) to...
Radiographically measurable disease by Lugano criteria (e.g., one or more nodal sites of disease ≥ 1.5 cm and/or extranodal sites of disease ≥ 1.0 cm in longest dimension)
If measurable bone marrow involvement or circulating disease has been confirmed in the absence of radiographically measurable disease, exceptions may be granted with study PI approval
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
WITHOUT BONE MARROW INVOLVEMENT: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
WITH BONE MARROW INVOLVEMENT: ANC ≥ 500/mm\^3
NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
WITHOUT BONE MARROW INVOLVEMENT: Platelets ≥ 75,000/mm\^3
NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
WITH BONE MARROW INVOLVEMENT: Platelets ≥ 25,000/mm\^3
NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 4 x upper limit of normal (ULN) (If hepatic involvement by lymphoma, or Gilbert's disease: ≤ 3 x ULN)
Aspartate aminotransferase (AST) ≤ 3 x ULN (If hepatic involvement by lymphoma: AST ≤ 5 x ULN)
Alanine aminotransferase (ALT) ≤ 3 x ULN (If hepatic involvement by lymphoma: ALT ≤ 5 x ULN)
Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
IF NOT RECEIVING ANTICOAGULANTS: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN
IF ON ANTICOAGULANT THERAPY: PT must be within therapeutic range of intended use of anticoagulants
IF NOT RECEIVING ANTICOAGULANTS: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
Left ventricular ejection fraction (LVEF) ≥ 50%
Mean corrected QT interval (QTc) (calculated from 3 electrocardiograms using Fridericia formula) ≤ 480 ms
WOMEN OF CHILDBEARING POTENTIAL: (WOCBP): Negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to abstain from heterosexual intercourse or use a highly effective method of birth control (defined as those resulting in a failure rate of \< 1% per year) during...
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) with no identified cause other than menopause
Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormone releasing intrauterine devices, and copper intrauterine devices. Note that oral...

What rules you out

Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy
Prior allogeneic stem cell transplant
Prior treatment with pacritinib or a janus kinase 2 (JAK2) inhibitor
Concomitant treatment with pirtobrutinib
Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy
Note: Shorter washout periods may be permitted with approval of the study PI, provided that the washout period is at least five half-lives of the drug prior to day 1 of protocol therapy
Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤ 100 mg per day), anti-vascular endothelial growth factor (anti-VEGF)...
Systemic treatment with medications with arrhythmogenic potential within 14 days prior to day 1 of protocol therapy. Shorter washout periods may be permitted with approval of the study PI, provided that the washout...
Systemic steroid therapy for any cause must be tapered down to ≤ 20 mg/day prednisone or equivalent. Exceptions are:
Use of brief (≤ 7 days) course of high dose corticosteroids (100 mg/day prednisone or equivalent) prior to initiation of study therapy for control of lymphoma-related symptoms
Inhaled or topical steroids
Use of mineralocorticoids for management of orthostatic hypotension
Use of physiologic doses of corticosteroids for management of adrenal insufficiency
Significant recent bleeding history defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 within 3 months prior to day 1 of protocol therapy, unless precipitated by...
Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
Factors that increase the risk for QT interval prolongation (eg, hypokalemia [defined as serum potassium \< 3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome)
Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 3 months of screening, any class III or IV cardiac disease as defined by the New...
Note: people with controlled, asymptomatic atrial fibrillation/flutter can enroll on study
Inability to swallow and retain an oral medication
Any active gastro-intestinal or metabolic condition that could significantly interfere with absorption of oral medication
Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
Known hypersensitivity to compounds of similar chemical composition to study agent or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate, or to loperamide...
Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement
Known history of progressive multifocal leukoencephalopathy (PML)
Prior or concurrent malignancy whose natural history or treatment could interfere with the safety or how well it works assessment of the protocol therapy
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator)...
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing to be done only in patients suspected of having infections or exposures. Patients with history of HBV infection (defined as negative...
Known active human immunodeficiency virus (HIV) infection. people who have an undetectable or unquantifiable HIV viral load with CD4 \> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed...
FEMALES ONLY: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

The study team makes the final eligibility decision.

Where it's taking place

Duarte, California, 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 Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.

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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.