Clinical Trials /

Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)

NCT01253460

Description:

The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Sapacitabine</span>, <span class="go-doc-concept go-doc-intervention">Cyclophosphamide</span>, <span class="go-doc-concept go-doc-intervention">Rituximab</span> for Relapsed <span class="go-doc-concept go-doc-disease">Chronic Lymphocytic Leukemia</span>, Small Lymphocytic <span class="go-doc-concept go-doc-disease">Lymphoma</span> (<span class="go-doc-concept go-doc-disease">CLL</span>/SLL) With <span class="go-doc-concept go-doc-keyword">Deletion</span> (11q22-23)

Title

  • Brief Title: Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
  • Official Title: A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH
  • Clinical Trial IDs

    NCT ID: NCT01253460

    ORG ID: 2010-0516

    NCI ID: NCI-2011-00119

    Trial Conditions

    Leukemia

    Trial Interventions

    Drug Synonyms Arms
    Cyclophosphamide Cytoxan, Neosar Cyclophosphamide, Rituximab + Sapacitabine
    Rituximab Rituxan Cyclophosphamide, Rituximab + Sapacitabine
    Sapacitabine Cyclophosphamide, Rituximab + Sapacitabine

    Trial Purpose

    The goal of this clinical research study is to learn if sapacitabine given in combination
    with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The
    safety of this drug combination will also be studied.

    Detailed Description

    The Study Drugs:

    Sapacitabine and cyclophosphamide are designed to damage the DNA (genetic material) of
    cancer cells, which may cause the cancer cells to die.

    Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer
    cells to die. It is also designed to cause the immune system to attack cancer cells.

    Study Drug Administration:

    If you are found to be eligible to take part in this study, you will receive sapacitabine by
    mouth 1 time a day on Days 1-3 of each 28-day cycle. Try to take sapacitabine at least 1
    hour before or 2 hours after a meal. On Days 1-3 of each cycle, you will also receive
    cyclophosphamide by vein over 30 minutes, starting 2 hours after you take sapacitabine.

    On Day 3 of Cycle 1 and Day 1 of Cycles 2 and beyond, you will receive rituximab by vein
    over 6-8 hours.

    If side effects occur, the study doctor may decide to lower your study drug doses. If you
    have side effects during a dose, the study staff will check you for any other problems for 2
    hours after the dose.

    Other Drugs:

    On Days 1-14 of Cycle 1, you will take allopurinol by mouth 1 time a day to lower the risk
    of kidney damage.

    Before each dose of cyclophosphamide, you will receive Zofran (ondansetron) by vein over a
    few seconds to lower the risk of nausea.

    About 30-60 minutes before each dose of rituximab, you will take Tylenol (acetaminophen) and
    Benadryl (diphenhydramine hydrochloride) by mouth to lower the risk of side effects such as
    fever and chills.

    Study Visits:

    On Day 1 of each cycle:

    - Blood (about 1-2 tablespoons) will be drawn for routine tests.

    - You will also have a physical exam, including measurement of your vital signs, except
    Cycle 1.

    - You will be asked about any side effects you may have had.

    On Days 8 and 22 of Cycle 1, and on Day 15 of every cycle:

    - Blood (about 1-2 tablespoons) will be drawn for routine tests.

    - You will be asked about any side effects you may have had.

    If your disease has had a good response and the doctor thinks it is needed to check the
    status of the disease, you will have a bone marrow aspiration and biopsy and a CT scan of
    the chest, abdomen and pelvis prior to Cycle 4 and possibly every other cycle after that
    (Cycles 6, 8, 10, and so on).

    Length of Study:

    Once your doctor thinks the disease has had its best response, you may receive 2 more cycles
    of study therapy after that. You will no longer be able to receive the study drugs if the
    disease gets worse or intolerable side effects occur.

    End-of-Treatment Visit:

    The following tests and procedures will be performed after your last cycle of study drugs:

    - You will have a physical exam, including measurement of your vital signs.

    - Blood (about 2 tablespoons) will be drawn for routine tests.

    Follow-Up Visits:

    At 2 and 6 months and 1 and 2 years after your last dose of study drugs:

    - You will be asked about any side effects you may have had and any drugs you may be
    taking.

    - You will have a physical exam, including measurement of your vital signs.

    - Blood (about 1 tablespoon) will be drawn for routine tests.

    - If the doctor thinks the disease has completely responded, you will have a CT scan of
    the neck, chest, abdomen, and pelvis to confirm the response. You will also have a bone
    marrow aspiration and biopsy to confirm the response.

    At 3 years after your last dose of study drugs and 1 time a year from then on:

    - You will be asked about any side effects you may have had and any drugs you may be
    taking.

    - You will have a physical exam, including measurement of your vital signs.

    - Blood (about 1 tablespoon) will be drawn for routine tests.

    - You will have a bone marrow aspiration and biopsy if the doctor decides it is needed to
    check the status of the disease.

    If the doctor thinks it is needed anytime during follow-up, you will have a CT scan of the
    neck, chest, abdomen, and pelvis to check the status of the disease.

    Starting at Year 3, the follow-up tests and procedures can be done by your local doctor if
    that is more convenient to you. The test results should be sent to MD Anderson.

    You should tell your study doctor or staff if you start another cancer treatment during
    follow-up. If that occurs, your follow-up in this study will stop.

    This is an investigational study. Sapacitabine is not FDA approved or commercially
    available. It is currently being used for research purposes only. Cyclophosphamide and
    rituximab are FDA approved and commercially available to treat CLL and SLL. The combination
    of sapacitabine, cyclophosphamide, and rituximab is investigational.

    Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

    Trial Arms

    Name Type Description Interventions
    Cyclophosphamide, Rituximab + Sapacitabine Experimental After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses. Cyclophosphamide, Rituximab, Sapacitabine

    Eligibility Criteria

    Inclusion Criteria:

    1. Patients must have a diagnosis of CLL/SLL and be previously treated

    2. Patients must have had FISH evaluation of leukemia cells within 3 months without
    intervening treatment demonstrating deletion 11q22-23

    3. Patients must have an indication for treatment by 2008 IWCLL Criteria

    4. Age >/= 18 years

    5. ECOG/Zubrod performance status </= 2

    6. Adequate renal and hepatic function as indicated by all the following: serum
    creatinine </= 2 mg/dL AND; alanine aminotransferase (ALT) </= 2.5 times upper limit
    of normal; AND total bilirubin </= 2.5 times upper limit of normal

    7. Patients must have an ANC >/= 500/uL, HGB >/= 8 gm/dL, PLT count >/= 20K/uL, unless
    attributed to marrow infiltration with CLL

    8. Patients must give written informed consent

    9. Patients of childbearing potential (females who have not been postmenopausal for at
    least 12 consecutive months or who have not undergone previous surgical sterilization
    or males who have not been surgically sterilized) must be willing to practice birth
    control during the study

    Exclusion Criteria:

    1. Pregnant or breast-feeding females

    2. Significant co-morbidity indicated by major organ system dysfunction

    3. Active infection, uncontrolled with intravenous antibiotics

    4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura
    (ITP)

    5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy,
    radiotherapy, high-dose corticosteroid therapy (prednisone >/= 60 mg daily, or
    equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with
    this trial

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Response Rate (ORR)

    Secondary Outcome Measures

    Trial Keywords

    Chronic Lymphocytic Leukemia

    CLL

    Small Lymphocytic Lymphoma

    SLL

    Cyclophosphamide

    Rituximab

    Sapacitabine

    Cytoxan

    Neosar

    Rituxan