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

Title

  • Brief Title: Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma
  • Official Title: Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 2014-0096
  • SECONDARY ID: NCI-2015-00843
  • NCT ID: NCT02272686

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
IbrutinibPCI-32765, ImbruvicaIbrutinib

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 (a transplant using your own stem cells). The safety of this drug will also be studied.

Detailed Description

      Study Drug Administration:

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

      If you miss a dose of ibrutinib, take it as soon as you remember on the same day. Take your
      next dose of ibrutinib at your regular time on the next day. Do not take 2 doses of ibrutinib
      on the same day to make up for a missed dose.

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

      The dose of ibrutinib you receive 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 your first dose of ibrutinib, blood (about 2 tablespoons) will be drawn for
      routine tests and to check your kidney and liver function. The blood draws may be performed
      at MD Anderson or at a lab closer to your home.

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

      Around 1 month after your first dose of ibrutinib, you 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 your first dose of
      ibrutinib:

        -  You will have a physical exam.

        -  You will have computed tomography (CT) scans to check the status of the disease.

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

      Length of Study:

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

      Your participation on this study will be over after about 3 years.

      Follow-Up Visit:

      You 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.

      If you had a positron emission tomography (PET) scan that was performed at the time of your
      transplant and the scan showed that the disease was still in your body, you will have a PET
      scan 1 time each year while taking ibrutinib. The PET scan will not be repeated if the
      results show that there is no disease in the body.

      This is an investigational study. Ibrutinib is FDA-approved and commercially available for
      the treatment of many types of cancers, including 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

NameTypeDescriptionInterventions
IbrutinibExperimentalIbrutinib 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Free Survival (DFS)
Time Frame:Two years
Safety Issue:
Description:Participants will be assessed for disease status and survival.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Three Years
Safety Issue:
Description:Participants will be assessed at 3 year time point for survival.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Lymphoma
  • Blood And Marrow Transplantation
  • Post Autologous Stem Cell Transplantation
  • SCT
  • B-cell lymphoma
  • Ibrutinib
  • PCI-32765
  • Imbruvica

Last Updated

December 5, 2018