Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma. (NCT03343847) | Clinical Trial Compass
WithdrawnPhase 3
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.
Stopped: Study was not feasible
0Started 2018-01-27
Plain-language summary
To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* 101 Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
* 102 Males or females ≥ 18 years of age at signing of the informed consent.
* 103 Documented active lymphoma.
* 104 Receiving cancer treatment with 14-, 21-, or 28-day cycles, using medication such as alkylating agents, anthracyclines, carboplatin, cisplatin, nucleoside analogs, or any other chemotherapy agents with thrombocytopenia as a warning or adverse reaction.
* 105 Subjects must have 2 platelet counts \< 30 x 109/L at least 7 days apart as a result of the chemotherapy administered in the cycle immediately preceding study entry, and no platelet count ≥ 50 x 109/L during 3-week period prior to enrollment despite dose delay or dose modification of chemotherapy regimen. The first platelet count \< 30 x 109/L may be collected from local lab platelet count and must be confirmed within the 28-day screening period.
* 106 Subjects must not have received chemotherapy within 14 days prior to first dose of investigational product.
* 107 Subjects must have at least 4 additional planned cycles of chemotherapy at study enrollment.
* 108 Subjects must …