A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

Conditions
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Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Cancer, Oncology, Thrombocytopenia

Intervention / Treatment
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* Biological: AMG 531


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study<br> | Biological: AMG 531<br>* Planned Cohorts: 100 mcg, 300 mcg, 700 mcg, 1000 mcg; Optional Cohorts: cohort expansion, schedule change, new dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Platelet Nadir | Change in platelet nadir from the previous qualifying cycle to the first treatment cycle. | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia | Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L) | 32 weeks | 
| Duration of Grade 3 or 4 Thrombocytopenia | Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively) | 32 weeks | 
| Percentage of Subjects That Received Platelet Transfusions | Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle | 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, chemotherapy induced thrombocytopenia, CIT, ICE, RICE, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, CHOP, ESHAP, DHAP, R-CHOP, R-ESHAP, R-DHAP