Clinical Trials /

Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma

NCT02272686

Description:

The goal of this clinical research study is to learn if ibrutinib can help to control lymphoma in patients who have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug will also be studied.

Related Conditions:
  • Mature B-Cell Lymphoma/Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Ibrutinib</span> Post <span class="go-doc-concept go-doc-intervention">Stem Cell</span> Transplantation (SCT) in Double-Hit B-Cell <span class="go-doc-concept go-doc-disease">Lymphoma</span>

Title

  • Brief Title: Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma
  • Official Title: Targeting BTK With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
  • Clinical Trial IDs

    NCT ID: NCT02272686

    ORG ID: 2014-0096

    NCI ID: NCI-2015-00843

    Trial Conditions

    Lymphoma

    Trial Interventions

    Drug Synonyms Arms
    Ibrutinib PCI-32765, Imbruvica Ibrutinib

    Trial Purpose

    The goal of this clinical research study is to learn if ibrutinib can help to control
    lymphoma in patients who have had an autologous stem cell transplant. The safety of this
    drug will also be studied.

    Detailed Description

    Study Drug Administration:

    If participant takes part in this study, they will take ibrutinib by mouth 1 time each day
    for up to 3 years. Participant must swallow the capsules whole with a glass (about 8 ounces)
    of water. Participant should not open, break, or chew the capsules. Participant should take
    ibrutinib at the same time every day.

    If participant misses a dose of ibrutinib, they should take it as soon as they remember on
    the same day. Participant should take their next dose of ibrutinib at their regular time on
    the next day. Participant should not take 2 doses of ibrutinib on the same day to make up
    for a missed dose.

    Participant will be given a study drug diary to write down what time they take each dose of
    ibrutinib. Participant needs to bring the study drug diary, any leftover study drug, and any
    empty study drug containers with them to each visit.

    The dose of ibrutinib participant receives may be lowered, if the doctor thinks it is
    needed.

    Study Visits:

    One (1) time during Weeks 1-4, 6, and 8 and then 1 time each month after that for up to 3
    years after participant's first dose of ibrutinib, blood (about 2 tablespoons) will be drawn
    for routine tests and to check their kidney and liver function. The blood draws may be
    performed at MD Anderson or at a lab closer to participant's home.

    If the study doctor thinks it is needed, participant may need to have these blood draws more
    often.

    Around 1 month after participant's first dose of ibrutinib, they will have a bone marrow
    biopsy/aspirate to check the status of the disease, if the study doctor thinks it is needed.
    To collect a bone marrow biopsy/aspirate, an area of the hip or other site is numbed with
    anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle.

    Around 3, 6, 9, and 12 months, then every 6 months for 3 years after participant's first
    dose of ibrutinib:

    - Participant will have a physical exam.

    - Participant will have computed tomography (CT) scans to check the status of the
    disease. If the doctor thinks it is needed, participant will also have a positron
    emission tomography (PET) scan.

    - Participant will have a bone marrow biopsy/aspirate to check the status of the disease.

    Length of Study:

    Participant may continue taking the study drug for up to 3 years. Participant will no longer
    be able to take the study drug if the disease gets worse, if intolerable side effects occur,
    or if they are unable to follow study directions.

    Patient's participation on this study will be over after about 3 years.

    Follow-Up Visit:

    Participant will continue to have the CT scans and blood draws described in the study visits
    section 1 time a year for up to 3 years.

    This is an investigational study. Ibrutinib is FDA-approved and commercially available for
    the treatment of mantle cell lymphoma with 1 prior therapy. The use of ibrutinib to treat
    double hit lymphoma after an autologous stem cell transplant is considered investigational.
    The study doctor can explain how the study drug is designed to work.

    Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

    Trial Arms

    Name Type Description Interventions
    Ibrutinib Experimental Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years. Ibrutinib

    Eligibility Criteria

    Inclusion Criteria:

    1. Patients with newly diagnosed double hit in first complete remission, anytime during
    the first 3 months after chemoimmunotherapy followed by autologous stem cell
    transplantation if there was no evidence of progression.

    2. Double hit lymphoma is defined as B-cell lymphoma with genetic abnormalities
    involving A) and in addition, B) and/or C): A) C-MYC arrangement or amplification by
    FISH study. B) BCL2 rearrangement or amplification by FISH study. C) BCL6
    rearrangement or amplification by FISH study.

    3. ANC >/= 1,000, platelets >/= 75,000.

    4. AST and/or ALT < 3 times the ULN.

    5. Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight).

    6. Male or female age >/= 18 years.

    7. ECOG performance status </= 2.

    8. Willing and able to participate in all required evaluations and procedures in this
    study protocol including swallowing capsules without difficulty.

    9. Ability to understand the purpose and risks of the study and provide signed and dated
    informed consent and authorization to use protected health information.

    10. Patient should preferably have received a pre-transplant conditioning with rituximab
    and Carmustine/Etoposide/Cytarabine/Melphalan/Rituxan (BEAM/R) . Other regimens which
    are similar may be accepted at the discretion of the PI.

    Exclusion Criteria:

    1. Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks,
    therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates
    within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of
    first dose of study drug.

    2. Relapsed within three months post transplant.

    3. History of other malignancies within the past year except for treated basal cell or
    squamous cell skin cancer or in situ cervical cancer.

    4. Known CNS lymphoma.

    5. 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 (moderate) or 4 (severe) cardiac disease as defined by the
    New York Heart Association Functional Classification.

    6. Requires treatment with a strong cytochrome P450 (CYP)3A inhibitor (i.e.
    Voriconazole, posaconazole, itraconazole, clarithromycin, etc.) or inducer
    (carbamazepine, rifampin, phenytoin, etc.).

    7. AST and/or ALT >/= 3 times the ULN.

    8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
    resection of the stomach or small bowel or symptomatic ulcerative colitis,
    symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

    9. Known history of human immunodeficiency virus or active infection with hepatitis C
    virus or hepatitis B virus or any uncontrolled active systemic infection.

    10. Positive pregnancy test in women of childbearing potential.

    11. Lactating or pregnant or will not agree to use contraception during the study and for
    30 days after the last dose of study drug if sexually active and able to bear
    children.

    12. Concomitant use of warfarin or other Vitamin K antagonists.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease-Free Survival Rate

    Secondary Outcome Measures

    Trial Keywords

    Lymphoma

    Blood And Marrow Transplantation

    Post Autologous Stem Cell Transplantation

    SCT

    B-cell lymphoma

    Ibrutinib

    PCI-32765

    Imbruvica