Study Complete
Sponsor ID
20050144

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

Sponsor ID
20050144
Clinicaltrials.gov ID
NCT00283439
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
39
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in Platelet Nadir

Timeframe: 32 weeks

Secondary Outcome Measures

Percentage of subjects experiencing grade 3 or 4 thrombocytopenia

Timeframe: 32 weeks

Duration of grade 3 or 4 thrombocytopenia

Timeframe: 32 weeks

Percentage of subjects that received platelet transfusions

Timeframe: 32 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.