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

Not Recruiting

Trial ID: NCT00283439

Purpose

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)

Eligibility


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

Intervention(s):

biological: AMG 531

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
6507362563

New Trial Alerts

Receive email alerts when trials open to patients.