Phase 2
N=50
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00299182 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Platelet (PLT) Nadir — 20.3; 26.3; 24.8; 22.5 K/μL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMG 531 (Drug); Rituximab (Drug); Cyclophosphamide (Drug); Vincristine (Drug); Doxorubicin (Drug); Dexamethasone (Drug); Methotrexate (Drug); Cytarabine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet (PLT) Nadir |
20.3; 26.3; 24.8; 22.5; 18.3; 8 | — |
| PRIMARY Days Platelets Count of < 100K/μL |
5.5; 5.3; 8.3; 6.8; 8; 9.3 | — |
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. Researchers will also look at the safety and effectiveness of AMG 531.
Primary Objectives:
1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's lymphoma.
2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD and R-Ara-C/MTX.
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy(chemo).
Secondary Objectives:
1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with chemotherapy.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00299182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.