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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00283439
First received: January 26, 2006
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Chemotherapy-Induced Thrombocytopenia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Cancer
Oncology
Thrombocytopenia
Biological: AMG 531
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in Platelet Nadir [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle


Enrollment: 39
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283439

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00283439     History of Changes
Other Study ID Numbers: 20050144
Study First Received: January 26, 2006
Results First Received: August 13, 2010
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

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:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Thrombocytopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014