Pediatric Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- biological: AMG 531
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