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A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

Primary Purpose

Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 531
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Thrombocytopenia focused on measuring NHL, chemotherapy induced thrombocytopenia, CIT, ICE, RICE, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, CHOP, ESHAP, DHAP, R-CHOP, R-ESHAP, R-DHAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Has adequate liver function must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry has serum creatinine concentration < or = 2 mg/dl Exclusion Criteria: More that 1 prior relapse chemotherapy regimen Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia Significant bleeding (CTC grade 3 or 4) History of thromboembolic disease Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive Use of any nitrosourea or mitomycin-C Has received any thrombocytopenic growth factor Has received a marrow or peripheral blood stem cell infusion Known hypersensitivity to any recombinant E. coli-derived product

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm: AMG 531 Dose-Escalating Cohort Study

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Platelet Nadir
    Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

    Secondary Outcome Measures

    Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
    Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)
    Duration of Grade 3 or 4 Thrombocytopenia
    Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
    Percentage of Subjects That Received Platelet Transfusions
    Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

    Full Information

    First Posted
    January 26, 2006
    Last Updated
    June 16, 2011
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00283439
    Brief Title
    A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
    Official Title
    An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Cancer, Oncology, Thrombocytopenia
    Keywords
    NHL, chemotherapy induced thrombocytopenia, CIT, ICE, RICE, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, CHOP, ESHAP, DHAP, R-CHOP, R-ESHAP, R-DHAP

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm: AMG 531 Dose-Escalating Cohort Study
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    AMG 531
    Intervention Description
    Planned Cohorts: 100 mcg, 300 mcg, 700 mcg, 1000 mcg; Optional Cohorts: cohort expansion, schedule change, new dose
    Primary Outcome Measure Information:
    Title
    Change in Platelet Nadir
    Description
    Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
    Time Frame
    32 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
    Description
    Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)
    Time Frame
    32 weeks
    Title
    Duration of Grade 3 or 4 Thrombocytopenia
    Description
    Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
    Time Frame
    32 weeks
    Title
    Percentage of Subjects That Received Platelet Transfusions
    Description
    Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
    Time Frame
    32 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Has adequate liver function must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry has serum creatinine concentration < or = 2 mg/dl Exclusion Criteria: More that 1 prior relapse chemotherapy regimen Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia Significant bleeding (CTC grade 3 or 4) History of thromboembolic disease Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive Use of any nitrosourea or mitomycin-C Has received any thrombocytopenic growth factor Has received a marrow or peripheral blood stem cell infusion Known hypersensitivity to any recombinant E. coli-derived product
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://www.nplate.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

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