Clinical trial · Interventional
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 531 | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- 1 mcg/ kg AMG531 Pre & Post Chemotherapy
- description
- Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
- interventionNames
- Drug: AMG 531
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Doxorubicin
- Drug: Dexamethasone
- Drug: Methotrexate
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- 3 mcg/ kg AMG531 Pre & Post Chemotherapy
- description
- Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients age \>/= 18 years. 3. Karnofsky Performance Scale \>/= 70. 4. 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). 5. 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. 6. Institutional Review Board (IRB)-approved signed informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. History of Central Nervous System (CNS) involvement. 3. Co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy. 4. Patients with history of deep vein thrombosis (DVT) or pulmonary embolus. 5. History of any platelet disorders including Idiopathic thrombocytopenic purpura (ITP), Thrombotic thrombocytopenic purpura (TTP) or bleeding disorders. 6. Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry. 7. 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.
References
Publications (0)
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