Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplanta… (NCT04716075) | Clinical Trial Compass
CompletedPhase 2
Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
Poland29 participantsStarted 2019-08-19
Plain-language summary
In this phase II multicenter trial we plan to use acalabrutinib before and after allogeneic hematopoietic stem cell transplantation (alloSCT) with reduced intensity conditioning (RIC) in patients with refractory/relapsed MCL and CLL with poor prognostic factors. Acalabrutinib will be used before alloSCT with the intention to reduce tumor burden and after transplant to augment disease control.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. after 1-4 therapy lines if del 17 or p53 mutation in \>10% of analyzed CLL cells (PB or BM) or
✓. after 2-4 therapy lines if high risk CLL (refractory or less than 24 months response to the last immunochemotherapy) or Confidential Page 15 of 82 Study Protocol v. 1.5 dated 06.07.2018
✓. Relapsing / refractory BTK-inhibitors naïve MCL patients with measurable disease or bone marrow involvement revealed in trephine biopsy or
✓. Patients fulfilling criteria 2 or 3, when ibrutinib therapy was initiated, responding to therapy
✓. Patient qualified for allo SCT procedure by the transplant center participating in the trial with identified sibling donor or initiated Poltransplant search for matched unrelated donor.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
✕. Patients failing 5 or more previous therapy lines
✕. Prior malignancy (or any other malignancy that requires 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 ≥ 5 years
✕. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or Confidential Page 16 of 82 Study Protocol v. 1.5 dated 06.07.2018 any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification (NYHA). Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
What they're measuring
1
Response Rate
Timeframe: through study completion on average 27 months
2
Response to therapy Minimum residual disease CR (MRD CR) rate
Timeframe: through study completion on average 27 months
3
Adverse event/serious adverse event incidence
Timeframe: acalabrutinib completion or discontinuation plus 30 days of the last acalabrutinib dose
✕. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or 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.
✕. Impaired hepatic function (as indicated by any of the following):
✕. Serum total bilirubin \> 2.5 x upper limit of normal (ULN)