Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia

What Was Tested

The trial (phase 2) is built around Romiplostim.

It had 1 arm (groups): romiplostim (experimental).

The registry classes the interventions as drug.

More on the Plan

Platelet transfusions are also limited by cost, supply, and associated risks, such as transfusion reactions, transmission of infection, alloimmunization and platelet refractoriness.

The predominant reason for a low platelet count in cancer patients receiving chemotherapy is a deficiency in platelet production.

Megakaryopoiesis, the process of development of mega-karyocytes and production of platelets, involves a highly complex cascade of events, from differentiation of immature progenitors to maturation of megakaryocytes and release of platelets into the bone marrow sinusoids.

Cytokines present within specialized bone marrow niches contribute to survival, proliferation, and differentiation of megakaryocytes.

Who Took Part

Enrollment: 3 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: ECOG performance status score \</= 3.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: thrombotic events in the previous 5 years before enrolment; other malignancies diagnosed in the previous 5 years before enrolment; severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-11 with completion listed for 2012-11.

It ran at 1 site in Italy.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: safety (time frame: participants will be followed for the duration of experimental treatment, an expected average of 6 months).

It also tracked 1 secondary outcome, for example activity.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 3 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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