Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ibrutinib in Treating Participants With Newly Diagnosed Low-Risk Mantle Cell Lymphoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282396
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well ibrutinib works in treating participants with newly diagnosed low-risk mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
CCND1 Positive CD20 Positive Mantle Cell Lymphoma Drug: Ibrutinib Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To measure the progression-free survival (PFS) of patients treated with ibrutinib in newly-diagnosed patients with low-risk mantle cell lymphoma (MCL).

SECONDARY OBJECTIVES:

I. To evaluate the safety of ibrutinib in newly-diagnosed untreated MCL. II. To evaluate the response rate of ibrutinib. III. To estimate the response duration.

EXPLORATORY OBJECTIVES:

I. To collect serial tumor-containing samples for our correlative study with Pharmacyclics.

OUTLINE:

Participants receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for 3 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 2 months for 6 months, every 2-4 months for 2 years, then every 4-6 months thereafter.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Ibrutinib in Newly Diagnosed Mantle Cell Lymphoma With Low-Risk Disease
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Treatment (ibrutinib)
Participants receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for 3 years in the absence of disease progression or unacceptable toxicity.
Drug: Ibrutinib
Given PO
Other Names:
  • BTK Inhibitor PCI-32765
  • CRA-032765
  • Imbruvica
  • PCI-32765




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to 3.5 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 3.5 years ]
    Logistic regression will be utilized to assess the effect of patient prognostic factors on the toxicity rate. Toxicity data by type and severity will be summarized by frequency tables.

  2. Response rate of ibrutinib [ Time Frame: Up to 3.5 years ]
    Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.

  3. Response duration [ Time Frame: Up to 3.5 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

  4. Overall survival [ Time Frame: Up to 3.5 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of MCL with CD20 and cyclin D1 positivity in tissue biopsy. Patients must have never received any prior therapy for their disease. Patients have been observed for 3 - 6 months with no progression as per imaging assessments
  • Low risk disease (without the following risk factors: blastoid variant histology, pleomorphic variant histology, Ki-67 >= 50%, high-risk MCL International Prognostic Index (MIPI), bulky tumors > 3 cm, presence of B symptoms)
  • Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form
  • Patients should in general have bi-dimensional measurable disease with their biggest tumor less than or equal to 3 cm. (Bone marrow or gastrointestinal [GI] only involvement is acceptable)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelet count > 100,000/mm^3
  • Patients who have bone marrow infiltration by MCL are eligible if their ANC is >= than 500 or their platelet level is >= than 50,000 /mm^3. Platelet transfusions are allowed
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) < 3 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present
  • Serum bilirubin < 1.5 mg/dl
  • Creatinine (Cr) clearance >= 30 mL/min
  • 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. Patients must be willing to receive transfusions of blood products
  • Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty and having a screening core biopsy
  • Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry
  • Male and female subjects who agree to use highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males

Exclusion Criteria:

  • Any serious medical condition including but not limited to uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, splenomegaly, leukemic features, active hemorrhage, or psychiatric illness that, in the investigator's opinion, places the patient at unacceptable risk and would prevent the subject from signing the informed consent form
  • Pregnant or breastfeeding females
  • Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
  • All patients with history of central nervous system lymphoma
  • History of stroke or intracranial hemorrhage within 6 months prior to signing the consent
  • 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
  • Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, bradycardia (< 50 beats per minute [bpm]), or corrected QT (QTc) > 500 msec
  • Unable to swallow capsules, 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
  • Requires concomitant anticoagulation with warfarin or equivalent vitamin K antagonist, active treatment for pulmonary embolism (PE)/ deep vein thrombosis (DVT) and persons with mechanical cardiac valves
  • Requires treatment with strong CYP3A4/5 inhibitors
  • Patients with blastoid and pleomorphic variants
  • Ki-67 to be equal or more than 50%
  • Patients with bi-dimensional measurable disease with a tumor >= 3 cm
  • Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
  • Any uncontrolled active systemic infection
  • Major surgery within 4 weeks of first dose of study drug
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  • Recent infection requiring systemic treatment that was completed =< 14 days before the first dose of study drug
  • Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)

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 ClinicalTrials.gov identifier (NCT number): NCT03282396


Contacts
Layout table for location contacts
Contact: Michael Wang, MD, MS 713-792-2860 miwang@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Luhua (Michael) Wang    713-792-2860      
Principal Investigator: Luhua (Michael) Wang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Luhua (Michael) Wang M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03282396     History of Changes
Other Study ID Numbers: 2016-0914
NCI-2018-01045 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0914 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin