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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014