Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.

What Was Tested

The trial (phase 3) is built around Romiplostim.

It had two arms (groups): Romiplostim (experimental) and Placebo (placebo comparator).

The study in a 2:1 randomization ratio(108 subjects to romiplostim).

The study in a 2:1 randomization ratio (54 subjects to placebo).

The registry classes the interventions as biological and other.

More on the Plan

This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of lymphomas, defined by 2 platelet counts \< 30 x 10\^9/L at least 7 days apart.

The study will consist of a screening period of up to 4 weeks, a 16-week treatment period, an end-of-treatment (EOT) visit, and long-term follow-up.

Who Took Part

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 102 Males or females ≥ 18 years of age at signing of the informed consent. 103 Documented active lymphoma. 107 Subjects must have at least 4 additional planned cycles of chemotherapy at study enrollment. 108 Subjects must be able to receive the same chemotherapy regimen (when possible, same schedule and same agents) for at least 2 additional cycles per investigator judgement. 109 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: 201 acute lymphoblastic leukemia; 202 acute myeloid leukemia; 203 any myeloid malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.

It started in 2018-01-27 with completion listed for 2021-07-17.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Platelet recovery, Platelet count, Depth of the platelet count, Subject Incidence of Platelet Transfusion, Bleeding events and Antibody Formation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.