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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03863184
Recruitment Status Recruiting
First Posted March 5, 2019
Last update posted October 15, 2019
This is a single-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.
This is a single-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects in complete response wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection. Subjects will be monitored for Minimal Residual Disease (MRD) status in peripheral blood at baseline and completion of 12 cycles of induction treatment using Adaptive Biotechnology Clonoseq assay, and then every 4 cycles. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.
|Experimental: ALR in Combination
Acalabrutinib, lenalidomide, and rituximab in combination
Acalabrutinib, oral, 100 mg BID, continuous
Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Histologically confirmed diagnosis of mantle cell lymphoma
- Age ≥ 18 years
- No prior systemic therapy for lymphoma
- Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in
two dimensions; measurable spleen disease is allowed
- Treatment should be indicated according to the treating physician
- ECOG performance status ≤ 2
- Required initial laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
- Platelet count ≥ 75,000 cells/mm3
- Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula
- Total bilirubin ≤ 2.0 x ULN
- AST/SGOT and ALT/SGPT ≤ 3.0 x ULN
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
intolerant to ASA may use low molecular weight heparin).
- All subjects must be registered into the mandatory Revlimid REMS® program, and be
willing and able to comply with the requirements of Revlimid REMS®.
- Patients of reproductive potential agree to use birth control throughout their
participation in this study, and for 28 days following study termination.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the Revlimid REMS® program. Females of childbearing potential (FCBP) must
have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL
within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for
Cycle 1 (prescriptions must be filled within 7 days). FCBP must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 28 days before and continue for at least 28 days after the last
dose of lenalidomide (or 2 days after the last dose of acalabrutinib, whichever is
longer). FCBP must also agree to ongoing pregnancy testing. Men must agree to use a
latex condom during sexual activity with a FCBP through one week post last dose even
if they have had a successful vasectomy. Men must also agree to refrain from sperm
donation during the same timeframe. See Appendix: Risks of Fetal Exposure, Pregnancy
Testing Guidelines and Acceptable Birth Control Methods.
- Understand and voluntarily sign an ICF prior to any study related assessments and
procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with blastoid histology
- Patients with known or suspected CNS involvement
- Viral infection with HIV or hepatitis type B or C. Seropositive HBV patients are
eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral
therapy during treatment and for additional six months after coming off study.
- Prior history of malignancies other than MCL unless the patient has been disease free
for ≥ 5 years from the signing of the ICF. Exceptions include basal cell carcinoma or
squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of
breast, or localized prostate cancer
- Active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing
signs/symptoms related to the infection without improvement despite appropriate
antibiotics, antiviral therapy and/or other treatment)
- 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, 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.
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
Patients on moderate CYP3A inhibitors can be considered for study after a washout
period of at least 7 days.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.
- Prothrombin time (PT)/INR or aPTT (in the absence of lupus anticoagulant) >2x ULN.
- Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole,
lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving
proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible
for enrollment to this study.
- History of significant cerebrovascular disease/event, including stroke or intracranial
hemorrhage, within 6 months before the first dose of study drug.
- Major surgical procedure within 28 days of first dose of study drug. Note: If a
subject had major surgery, they must have recovered adequately from any toxicity
and/or complications from the intervention before the first dose of study drug.
- Patients with a history of toxic epidermal necrolysis or Stevens-Johnson syndrome
- Patients that are pregnant or breast feeding
- Known hypersensitivity to any study drug or excipients
- Patient on corticosteroids within two weeks prior to study entry, except for
prednisone ≤ 20 mg/day or equivalent for purposes other than treating MCL
- Use of any other experimental drug or therapy within 28 days of baseline
- Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis
- Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from participating in the study
- Known prior exposure to BTK inhibitor
Contact: Amelyn Rodriguez, R.N. 2127461362 firstname.lastname@example.org
Contact: Rita Vaccaro, R.N. 2127460702 email@example.com
United States, New York
Weill Cornell Medicine
Weill Medical College of Cornell University
Principal Investigator: Jia Ruan, M.D., Ph.D. Weill Cornell Medicine