Status:
COMPLETED
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
Lead Sponsor:
Amgen
Conditions:
Chemotherapy-Induced Thrombocytopenia
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00283439
Start Date
October 1 2005
End Date
September 1 2008
Last Update
June 20 2011
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