- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283439
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
June 16, 2011 updated by: Amgen
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study
|
Planned Cohorts:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Platelet Nadir
Time Frame: 32 weeks
|
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
|
32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
32 weeks
|
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)
|
32 weeks
|
Percentage of Subjects That Received Platelet Transfusions
Time Frame: 32 weeks
|
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
|
32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 26, 2006
First Submitted That Met QC Criteria
January 26, 2006
First Posted (Estimate)
January 30, 2006
Study Record Updates
Last Update Posted (Estimate)
June 20, 2011
Last Update Submitted That Met QC Criteria
June 16, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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