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A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
Plain-language guide to NCT00283439: phase 1, phase 2 interventional trial of Romiplostim, 39 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00283439
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2005-10
- Completion (planned or actual)
- 2008-05
- Participants
- 39 (actual)
- Design
- open label (everyone knows who gets what), supportive_care
- Conditions studied
- Chemotherapy-Induced Thrombocytopenia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Cancer; Oncology; Thrombocytopenia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Romiplostim.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as biological.
Who Took Part
The registry lists 39 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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. 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.
The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: more that 1 prior relapse chemotherapy regimen; sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia; history of thromboembolic disease.
How the Study Was Run
Design: parallel-group and open-label.
The Romiplostim group and the comparison group ran side by side rather than switching.
Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2005-10 with completion listed for 2008-05.
Its stated primary purpose is supportive care.
What Was Measured
Primary outcome: Change in Platelet Nadir (time frame: 32 weeks).
It also tracked 3 secondary outcomes, for example Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia, Duration of Grade 3 or 4 Thrombocytopenia and Percentage of Subjects That Received Platelet Transfusions.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Romiplostim in 39 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.