Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Mantle Cell Lymphoma (MCL), T-cell Lymphoma (TCL), and Diffuse Large B-Cell Lymphoma (DLBCL)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical research study is to find the highest tolerable dose of carfilzomib
      that can be given to patients with lymphoma after a stem cell transplant. The safety of this
      drug will also be studied.

      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells
      cannot repair themselves, this may cause them to die.
    

Detailed description: 
      Study Groups:

      If you agree to take part in this study, you will be assigned to a dose level of carfilzomib
      based on when you joined this study. Up to 4 dose levels of carfilzomib will be tested. Three
      (3) participants will be enrolled at each dose level until the highest tolerable dose level
      is found. Each new group will receive a higher dose than the group before it, if no
      intolerable side effects were seen. When the highest tolerable dose is found, more
      participants may be enrolled at that dose level.

      Study Treatment:

      Each study cycle is 28 days.

      On Days 1, 2, 15, and 16 of each cycle, you will receive carfilzomib by vein over 30 minutes.
      You will receive hydration by vein before and after each infusion of carfilzomib in Cycle 1.
      This may be repeated in Cycle 2, if your doctor thinks it is needed. On these days during
      Cycles 1 and 2, before you receive carfilzomib you will receive dexamethasone by vein or as a
      tablet by mouth. Dexamethasone may help prevent possible infusion reactions. You may continue
      to receive dexamethasone before each dose of each cycle depending how well you tolerate the
      infusion.

      You will be monitored closely for at least 1 hour for possible infusion reactions after each
      dose during Cycle 1 and on Day 1 of Cycle 2. If you have an infusion reaction, your doctor
      may delay or stop the infusion, and you may receive drugs to help relieve the symptoms.

      You will have about 12 days of "rest" between each cycle of treatment (during this time you
      will not receive carfilzomib).

      Study Visits:

      On Day 1 (+ or - 3 days) of Cycle 1 and on Day 1 of all other cycles, women who are able to
      become pregnant will have blood (about 1 teaspoon) drawn for a pregnancy test. To take part
      in this study, you must not be pregnant.

      About 1 day before you receive carfilzomib in each cycle:

        -  You will have a physical exam including measurement of your vital signs (blood pressure,
           heart rate, temperature, and breathing rate).

        -  You will be asked about how you are feeling and about any side effects you may be
           having.

      About 1 day and about 15 days before you receive carfilzomib in each cycle, blood (about 2
      tablespoons) will be drawn for routine tests and to check your kidney and liver function.

      At any point that your doctor thinks they are needed, you will have a bone marrow aspiration
      and computed tomography (CT) and/or positron emission tomography (PET) scans to check the
      status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is
      numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large
      needle.

      End-of-Treatment Visit:

      Within 30 days of your last dose of study drug, you will return to the clinic. The following
      tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your vital signs.

        -  You will be asked about how you are feeling and about any side effects you may be
           having.

        -  Blood (about 4 tablespoons) will be drawn for routine tests and to check the status of
           the disease.

      During follow-up, the study staff may also contact you and your local doctor by telephone to
      ask about your health.

      Length of Study:

      You may remain in this study for about 2 years from the time of first dose. You may receive
      up to 6 cycles of treatment during this time, which will take about 7 months to complete. You
      will be taken off study early if the disease gets worse, you cannot keep appointments, you
      miss more than 2 doses of carfilzomib in a row, if intolerable side effects occur, or if you
      decide that you want to leave the study early.

      This is an investigational study. Carfilzomib is FDA approved and commercially available for
      the treatment of multiple myeloma. The use of carfilzomib to treat lymphoma after a stem cell
      transplant is investigational.

      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
    

Intervention name(s): Carfilzomib; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose: 20/20 mg/m2 by vein on Days 1, 2, 15, and 16 of each 28 day cycle.; 4 mg by vein or mouth prior to each Carfilzomib dose in Cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, it should be restarted and administered prior to subsequent doses for reactions.
Other intervention name(s): Decadron
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood And Marrow Transplantation; Mantle cell lymphoma; MCL; T-cell lymphoma; TCL; Diffuse large b-cell lymphoma; DLBCL; Autologous stem cell transplantation; ASCT; Carfilzomib; CFZ; Dexamethasone; Decadron