At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of previously untreated aggressive non-Hodgkin's lymphoma (including mantle cell lymphoma) receiving R-HyperCVAD and R-Ara-C/MTX, or eligible if Rituximab contraindicated, or if switched to (R)Hyper-CVAD after initial (R)CHOP for aggressive disease
- ✓Age ≥18 years
- ✓Karnofsky Performance Scale ≥70
- ✓Adequate hematologic function: ANC ≥1000/mm³, platelets ≥100,000/mm³, hemoglobin ≥8 g/dL
- ✕Pregnant or lactating women
- ✕History of central nervous system (CNS) involvement
- ✕Co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy
- ✕History of deep vein thrombosis (DVT) or pulmonary embolus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Study of AMG 531 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Patients With Aggressive Non-Hodgkin's Lymphoma Receiving R-HyperCVAD Alternating With R-Ara-C/MTX
In Brief
A Phase 2 clinical trial evaluating AMG 531, Rituximab, and 7 other interventions for Lymphoma. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.
375 mg/m\^2 by vein over 4-6 hour infusion day 1, each cycle.
300 mg/m\^2 by vein over 3 hours every 12 hours for 6 doses (days 2-4), Cycles 1,3, \& 5.
1.4 mg/m\^2/dose (maximum 2 mg) by vein over 15 minutes Days 5 and 12, Cycles 1,3,\& 5.
50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.
40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.
200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.
3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.
Arm A: Placebo - subcutaneous injection administered on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm B: Placebo - subcutaneous injection administered on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.