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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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : AMG 531

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

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

External Links

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Contact information

Primary Contact:

Sipra Choudhury 6507362563

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

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