Trial Search Results

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults 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 currently not accepting patients for this trial.

Lead Sponsor:

Amgen

Stanford Investigator(s):

Intervention(s):

  • Biological: AMG 531

Phase:

Phase 1/Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
6507362563
Not Recruiting