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

Phase 1

Completed

• Conditions: Chemotherapy-Induced Thrombocytopenia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Cancer; Oncology; Thrombocytopenia
• Interventions: Biological: AMG 531

• Registration Number: NCT00283439
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-30
• Primary Completion: 2008-05
• Study Completion: 2008-09
• Results First Submitted: 2010-08-13
• Results First Submitted QC: 2010-08-13
• Results First Posted: 2010-09-13
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Arm: AMG 531 Dose-Escalating Cohort Study	AMG 531	-

Primary Outcome Measures

Name	Time	Method
Change in Platelet Nadir	32 weeks	Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Secondary Outcome Measures

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