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Trial record 36 of 307 for:    IBRUTINIB

Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03232307
Recruitment Status : Withdrawn (Sponsor does not wish to proceed)
First Posted : July 27, 2017
Last Update Posted : May 22, 2019
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if a combination of ibrutinib, rituximab, and lenalidomide can help control newly diagnosed mantle cell lymphoma (MCL) in patients over 65. The safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Hematopoietic/Lymphoid Cancer Mantle Cell Lymphoma Drug: Ibrutinib Drug: Rituximab Drug: Lenalidomide Drug: Dexamethasone Sodium Sulfate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Ibrutinib + Rituximab + Lenalidomide
Ibrutinib by mouth each day. Lenalidomide by mouth on Days 1-21. Rituximab by vein on Days 1, 8, 15, and 22 of Cycles 1 and 2. After that, Rituximab by vein on Day 1 of Cycles 3-8 and then every other cycle after that (Cycles 10, 12, 14, and so on). Study cycles are 28 days.
Drug: Ibrutinib
Orally at 560 mg daily for 28 days (one cycle) up to Cycle 11. Starting at Cycle 12, a 2 month supply of ibrutinib dispensed every other cycle. After 3 years, patients treated with ibrutinib in continuous cycles until progression of disease or unacceptable toxicity.
Other Names:
  • PCI-32765
  • Imbruvica

Drug: Rituximab
375 mg/m^2 intravenous infusion (IV) given on Days 1, 8, 15 and 22 for Cycles 1 and 2. Then, Day 1 of every cycle, for Cycles 3 - 8. Following Cycle 8 Rituximab given on Day 1 of every other cycle for up to 2 years.
Other Name: Rituxan

Drug: Lenalidomide
Orally at 20 mg daily on Days 1 - 21 of each 28 day cycle for up to one year.
Other Names:
  • CC-5013
  • Revlimid

Drug: Dexamethasone Sodium Sulfate
Orally 40 mg weekly administered only for the first 2 cycles.
Other Name: Decadron

Primary Outcome Measures :
  1. Overall Response Rate (ORR) at 4 Months of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) [ Time Frame: 4 months ]
    Response assessed according to the International Workshop Standardization Response Criteria for Non-Hodgkin's Lymphoma (Cheson, 2014)

Secondary Outcome Measures :
  1. Summary of Adverse Events of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) [ Time Frame: After 1 cycle, 28 days ]
    Adverse events assessed according to the Common Toxicity Criteria for Adverse Events version 4.03. (CTCAE v4.03)

Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity in tissue biopsy.
  2. Ki-67 >/= 50%.
  3. Patients must have never received any prior systemic therapy for their disease.
  4. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  5. Age > 65 years at the time of signing the informed consent.
  6. Patients should in general have bi-dimensional measurable disease using the Cheson criteria (Measureable disease by computed tomography (CT) scan defined as at least 1 lesion that measures =/>1.5 cm in single dimension) (bone marrow or gastrointestinal (GI) only involvement is acceptable).
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  8. Absolute neutrophil count (ANC) >/= 1000/mm^3 without transfusion support
  9. Platelet count > 100,000/mm^3. Patients who have bone marrow infiltration by MCL are eligible if their platelet level is >/= 50,000 /mm^3 independent of platelet transfusions.
  10. aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) </= 3 x upper limit of normal.
  11. Serum bilirubin <1.5 mg/dl unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  12. Creatinine (Cr) Clearance >/= 25 mL/min (per Cockcroft-Gault Equation ),
  13. Disease free of prior malignancies of equal to or greater than 6 months with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 years.
  14. Patients must be willing to receive transfusions of blood products.
  15. Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
  16. Men must agree 1) to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of lenalidomide and ibrutinib;2) to not donate sperm during and after the study. 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 prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method (11.8) and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide through 90 days and ibrutinib through 30 days after the last dose of study drug. FCBP must also agree to ongoing pregnancy testing.
  17. All patients must be registered in and must comply with all requirements of the Revlimid Rems™ program.

Exclusion Criteria:

  1. Any serious medical condition that, in the investigator opinion, places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection requiring treatment with intravenous (IV) antibiotics, antiviral or antifungal agents, active hemorrhage, or psychiatric illness in the investigator's opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.
  2. Pregnant or breastfeeding females.
  3. Known human immunodeficiency virus (HIV) infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease. These patients should be optimized by GI consultation for Hepatitis B and Infectious Disease consult for Hepatitis C.
  4. The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient's health and survival, than of the MCL, within the subsequent 6 months at the time of consent.
  5. History of stroke or intracranial hemorrhage within 6 months prior to signing the consent
  6. Patients at high-risk for thromboembolic disease, such as those with prior heterotopic ossification (h/o) deep venous thrombosis (DVT).
  7. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any Class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association Classification
  8. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular block (AV block) type II, 3rd degree block, bradycardia (< 50bpm), or QTc >500 msec.
  9. Patients with persistent and uncontrolled atrial fibrillation even if rate controlled.
  10. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  11. Major surgery or wound that has not fully healed within 4 weeks or vaccination with live attenuated vaccines within 4 weeks of the first dose of study drugs.
  12. Requires concomitant anticoagulation with warfarin or equivalent vitamin K antagonist.
  13. Requires treatment with strong Cytochrome P4503A (CYP3A) inhibitors.
  14. All patients with central nervous system lymphoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03232307

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Janssen Scientific Affairs, LLC
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Principal Investigator: Michael Wang, MD, MS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT03232307     History of Changes
Other Study ID Numbers: 2016-0280
NCI-2018-01271 ( Registry Identifier: NCI CTRP )
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Hematopoietic/Lymphoid Cancer
Mantle Cell Lymphoma

Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Sodium sulfate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological