Clinical Trials /

Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

NCT01665768

Description:

This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.

Related Conditions:
  • Hodgkin Lymphoma
  • Mature B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Maintenance <span class="go-doc-concept go-doc-intervention">Rituximab</span> With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

Title

  • Brief Title: Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
  • Official Title: A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas and Hodgkin's Lymphoma
  • Clinical Trial IDs

    NCT ID: NCT01665768

    ORG ID: J1228

    NCI ID: NA_00067315

    Trial Conditions

    CD20+, B-cell Lymphomas

    Mantle Cell Lymphoma

    Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL)

    Transformed Lymphoma/DLBCL/PMBCL

    Hodgkin's Disease

    Trial Interventions

    Drug Synonyms Arms
    Everolimus and Rituximab RAD001 Everolimus and Rituximab

    Trial Purpose

    This research is being done to determine if combining an investigational drug called
    Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose
    chemotherapy.

    Detailed Description

    Everolimus is a pill that interferes with lymphoma cell growth by blocking a cellular
    pathway important in causing cancer cells to grow, called mTor. Rituximab is an intravenous
    medication that specifically attacks a protein commonly found on lymphoma cells called CD20.

    Rituximab is already widely used to treat multiple forms of lymphoma. Moreover, continuing
    rituximab after the completion of chemotherapy is already commonly used to help patients
    stay in remission longer. Everolimus has been shown in many types of relapsed lymphoma to
    decrease the size of lymph nodes by itself. Everolimus is approved by the Food and Drug
    Administration (FDA) for the treatment of advanced kidney cancer and subependymal giant cell
    astocytoma. It is not approved for use in lymphoma. The use of everolimus in this research
    study is investigational. The word "investigational" means that everolimus is not approved
    for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of
    everolimus in this study.

    The combination of everolimus and rituximab for 1 year after high dose therapy is also new.
    We believe the combination of these medications right after your chemotherapy will be more
    effective in attacking your remaining cancer before they have time to re-grow.

    The usual treatment of lymphoma after high-dose chemotherapy is observation. After your
    body has fully recovered from the effects of the chemotherapy, you will receive everolimus
    daily for one year and IV rituximab four times during that year.

    Trial Arms

    Name Type Description Interventions
    Everolimus and Rituximab Experimental After your body has fully recovered from the effects of the chemotherapy, you will receive everolimus daily for one year and IV rituximab four times during that year. Everolimus and Rituximab

    Eligibility Criteria

    Inclusion Criteria:

    - Age >18 years of age

    - ECOG performance status 2

    - INR 2

    - Adequate renal and hepatic function defined as a serum creatinine <2.0mg/dL, total
    bilirubin <5mg/dL, and AST and ALT 2.5 ULN.

    - Platelet count >75 x 109/L

    - Hemoglobin >10mg/dL

    - ANC >3.0x109/L

    - Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L and fasting triglycerides 2.5
    x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can
    only be included after initiation of appropriate lipid lowering medication.

    - A willingness to use an accepted and effective method of birth control for sexually
    active women of childbearing potential during the study and for 8 weeks after the end
    of study drug treatment.

    - Ability to sign informed consent

    Exclusion Criteria:

    - Patient who have previously received an mTor inhibitor

    - Patients who are pre-terminal or moribund

    - Patients with active bacterial of fungal infections requiring oral or intravenous
    antimicrobials are not eligible until resolution of the infection

    - Female patients who are pregnant or breast feeding, or of reproductive potential who
    are not using effective birth control methods. Adequate contraception must be used
    throughout the trial and for 8 weeks after the last dose of study drug.

    - Patients with known intolerance to rituximab

    - HIV positive, Hepatitis B positive, Hepatitis C positive individuals

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of patients with adverse events when given treatment with maintenance rituximab and prolonged mTOR inhibition with everolimus in CD20+, B cell lymphomas and Hodgkin's Lymphoma after high-dose consolidative therapy

    Secondary Outcome Measures

    1) Event free survival at three years based on histology

    2) Reduction of the frequency of circulating cancer cells due to maintenance rituximab with everolimus treatment

    3) Sensitivity, in-vivo, of relapsed disease to mTor kinase inhibition.

    Trial Keywords