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Completed

NCT Number: NCT00283439

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

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.

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Key information

Conditions

Chemotherapy-Induced Thrombocytopenia Blood Platelet Disorders Cancer Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma Oncology Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 531

Biological

Planned Cohorts:

  • 100 mcg,
  • 300 mcg,
  • 700 mcg,
  • 1000 mcg;

Optional Cohorts:

  • cohort expansion,
  • schedule change,
  • new dose

Primary outcomes

  1. Change in Platelet Nadir

    Time frame: 32 weeks

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 30, 2006
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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