Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma

NCT04402138 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LYM 155
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma.

Conditions

Mantle Cell Lymphoma

Keywords

Acalabrutinib; Non Hodgkin's lymphoma; Blood or Marrow transplant; BMT; Maintenance therapy; Bruton's Tyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate (PFS) at 2 Years Post-Blood or Marrow Transplant (BMT)

  Progression Free Survival Rate is defined as the Kaplan-Meier estimate of the percentage of participants who are alive and free of disease progression according to Response Evaluation Criteria in Lymphoma (RECIL 2017) for up to 2 years post-BMT. According to RECIL, disease progression is defined as following criteria: \>20% increase in sum of longest diameters of target lesions, for small lymph nodes measuring \<15 mm post therapy, a minimum absolute increase of 5 mm and the longest diameter should exceed 15mm, or appearance of new lesions.

  2 years after date of BMT procedure for each patient

Secondary Outcomes (3)

• Conversion Rate From Minimal Residual Disease Positive (MRD+) to Minimal Residual Disease Negative (MRD-)

  Assessed at day 100 post-BMT procedure (prior to beginning maintenance treatment with study drug) and 2 years post-BMT

• Minimal Residual Disease (MRD) Correlation With Progression Free Survival (PFS)

  2 years after date of BMT procedure for each patient

• Incidence of Grade 3 or Greater Treatment-Related Adverse Events

  Safety assessment will be done every cycle up to 2 years post-BMT

Study Arms (1)

Acalabrutinib

EXPERIMENTAL

Acalabrutinib will be self-administered orally for up to approximately 2 years post-BMT.

Drug: Acalabrutinib

Interventions

Acalabrutinib DRUG

Acalabrutinib 129 mg will be self-administered orally twice daily (BID) starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT.

Also known as: Calquence

Acalabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria in order to be included in this research study:
• Written informed consent, according to local guidelines, signed by the subject or by a legal guardian prior to the performance of any study-related screening procedures.
• Men and women ≥18 years-of-age at the time of signature of the informed consent form (ICF).
• A diagnosis of MCL confirmed by one of the following:
• t(11;14) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation
• expression of cyclin D1 confirmed by immunohistochemistry.
• Subject must have completed induction chemotherapy and plan to and be eligible to receive their first BMT per standard of care.
• Availability of an archival paraffin-embedded tumor block for MRD testing.
• The Investigator anticipates that the subject will meet the appropriate lab requirements listed in Screening #2 by Day 100.
• Patients who received prior therapy with a BTK inhibitor are eligible to enroll.
• Adequate organ system function defined as:
• Absolute neutrophil count (ANC) ≥1,000/mm3.
• Total bilirubin ≤1.5 x the upper limit of normal (ULN) (except for previously documented Gilbert's syndrome)
• Platelet count ≥75,000/mm3. Platelet infusions to meet eligibility criteria are not allowed within 3 days of study enrollment.
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x ULN

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Subjects who have relapsed or progressed at any time prior to BM
• Subjects with known mutations that confer resistance to a BTK inhibitor.
• Confirmed clinical PD since the time of BMT
• Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥2 years or that will not limit survival to \<2 years. The exceptions are:
• Subjects treated with curative intent \>2 years prior to enrollment and have a low probability of recurrence.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
• Known history of infection with human immunodeficiency virus (HIV) or any uncontrolled active systemic bacterial, fungal, parasitic or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection progression are present.
• Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).
• Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
• Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
• Requires treatment with a strong CYP3A4 inhibitor/inducer
• Requires or is receiving anticoagulation treatment with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.
• Prothrombin time (PT)/ international normalized ratio (INR) or activated partial thromboplastin time (aPTT) \>2 x ULN (in the absence of lupus anticoagulant).

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Acerta Pharma, LLC: collaborator

Study Sites (4)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Tulane University, Office of Clinical Research

New Orleans, Louisiana, 70112, United States

Location

HCA Midwest

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

SCRI.InnovationsMedical@scri.com

844-710-6157

Study Officials

• Michael Tees, MD

  Colorado Blood Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 26, 2020
• Study Start: August 7, 2020
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Locations

US (4)