Status:
COMPLETED
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Amgen
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Resea...
Detailed Description
Platelets are cells that help make the blood clot. A decrease in platelets can cause bleeding, which may prevent or delay a patient from receiving chemotherapy. R-HyperCVAD (rituximab, cyclophosphamid...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of previously untreated aggressive non-Hodgkin's lymphoma, including patients with mantle cell lymphoma, who will be or are receiving treatment with R-HyperCVAD and R-Ara-C/MTX. Patients in whom Rituximab is not used, due to contraindication, will be eligible. Patients whose therapy was switched to (R)Hyper-CVAD after initial treatment with (R)CHOP, because of aggressive disease will also be eligible for the study.
- Patients age \>/= 18 years.
- Karnofsky Performance Scale \>/= 70.
- Adequate hematologic (ANC \>/= 1000/mm(3), platelet count \>/= 100,000/mm(3) and Hgb \>/= 8gm/dL), renal (serum creatinine \< 2mg/dL), and hepatic functions (total bilirubin \</= 2 times, serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \</= 3 times the upper limit of the respective normal range).
- Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
- Institutional Review Board (IRB)-approved signed informed consent.
Exclusion
- Pregnant or lactating women.
- History of Central Nervous System (CNS) involvement.
- Co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy.
- Patients with history of deep vein thrombosis (DVT) or pulmonary embolus.
- History of any platelet disorders including Idiopathic thrombocytopenic purpura (ITP), Thrombotic thrombocytopenic purpura (TTP) or bleeding disorders.
- Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.
- Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), dysrrhythmia, or recent history of myocardial ischemia (MI) or ischemia, transient ischemic attack or cerebrovascular accident (CVA) within the previous 6 months of study entry.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00299182
Start Date
March 1 2006
End Date
April 1 2012
Last Update
September 21 2021
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030