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

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ClinicalTrials.gov Identifier: NCT00283439
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : September 13, 2010
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Thrombocytopenia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Cancer Oncology Thrombocytopenia Biological: AMG 531 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : October 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romiplostim

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study Biological: AMG 531

Planned Cohorts:

  1. 100 mcg,
  2. 300 mcg,
  3. 700 mcg,

  4. 1000 mcg;

    Optional Cohorts:

  5. cohort expansion,
  6. schedule change,
  7. new dose


Outcome Measures
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Primary Outcome Measures :
  1. Change in Platelet Nadir [ Time Frame: 32 weeks ]
    Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.


Secondary Outcome Measures :
  1. Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia [ Time Frame: 32 weeks ]
    Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)

  2. Duration of Grade 3 or 4 Thrombocytopenia [ Time Frame: 32 weeks ]
    Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)

  3. Percentage of Subjects That Received Platelet Transfusions [ Time Frame: 32 weeks ]
    Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283439


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00283439    
Other Study ID Numbers: 20050144
First Posted: January 30, 2006    Key Record Dates
Results First Posted: September 13, 2010
Last Update Posted: June 20, 2011
Last Verified: June 2011
Keywords provided by Amgen:
NHL
chemotherapy induced thrombocytopenia
CIT
ICE
RICE
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
 CHOP
ESHAP
DHAP
R-CHOP
R-ESHAP
R-DHAP
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Thrombocytopenia
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases