Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma (NCT04673266) | Clinical Trial Compass
CompletedPhase 2
Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma
United States11 participantsStarted 2020-12-14
Plain-language summary
The purpose of this study is to see if the study drug, romiplostim, helps low platelet count caused by standard chemotherapy treatment for lymphoma. This study will also look at whether romiplostim can prevent the need for chemotherapy dose delays, chemotherapy dose reductions, and platelet transfusions. In addition, we will determine how safe it is to give romiplostim to people with lymphoma who have low platelet count from chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult patients ≥ 18 years old diagnosed with any type of lymphoma.
* Receiving chemotherapy-based treatment known to cause thrombocytopenia. Eligibility is limited to regimens with a 21-day cycle. Previous single-agent anti-CD20 antibody or radiotherapy will not count as a line of treatment. Eligible regimens include those based on a platinum backbone (e.g. ICE, DHAX, DHAP, GemOx, GDP, ESHAP), those based on a doxorubicin backbone (e.g. CHOP, CDOP, HyperCVAD, BEACOPP) or on a high-dose cytarabine backbone (e.g.HiDAC). Of note, treatment programs which involve sequential administration of two or more regimens (e.g. CHOP-\>ICE or CHOP-DHAX) are eligible as long as the patient is planned for at least two more cycles of the regimen on which the CIT was initially observed. Regimens with inherent dose-adjustments by blood counts (e.g. da-EPOCH) are ineligible unless the treating oncologist is not planning to increase treatment doses on subsequent cycles.
* History of a severe treatment-related thrombocytopenia during the most recent cycle of treatment, as defined by one or more of the following criteria:
* PLT \< 50,000 on day 1 (- 2 days) of the subsequent treatment cycle.
* Grade 4 thrombocytopenia, defined as PLT \<25,000 cells/mcl and/or transfusion for thrombocytopenia or bleeding. Need for PLT transfusion in order to meet minimal PLT criteria for invasive procedures will not count for eligibility.
* Patient is planned for at least one more cycle of…
What they're measuring
1
measure of incidence of indication for dose delays