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

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