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

Not Recruiting

Trial ID: NCT00283439


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.

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.

Stanford Investigator(s)


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

   - 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


biological: AMG 531

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury

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