A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Status and phase
Withdrawn
Phase 3
Conditions
Mantle Cell Lymphoma
Treatments
Drug: ibrutinib
Drug: acalabrutinib
Drug: rituximab
Details and patient eligibility
About
This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Men and women ≥ 18 years of age.
- Pathologically confirmed mantle cell lymphoma (MCL).
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest).
- Disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (MCL).
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion criteria
- Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
- Prior exposure to ibrutinib or to a B-cell receptor (BCR) inhibitor.
- Significant cardiovascular disease.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection.
- Known history of infection with human immunodeficiency virus (HIV).
- History of hepatitis B (HBV) infection or active infection with hepatitis C (HCV).
- Breastfeeding or pregnant.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
0 participants in 3 patient groups
acalabrutinib plus rituximab
Experimental group
Description:
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).
Treatment:
Drug: acalabrutinib
Drug: rituximab
ibrutinib
Active Comparator group
Description:
Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).
Treatment:
Drug: ibrutinib
acalabrutinib
Experimental group
Description:
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).
Treatment:
Drug: acalabrutinib
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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