Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02052882|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2014
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Isolated Chemotherapy-induced Thrombocytopenia||Biological: romiplostim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia|
|Study Start Date :||January 30, 2014|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy.
Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel.
- Achievement of platelet counts of ≥ 100,000/mcL [ Time Frame: within 3 weeks after treatment ]The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.
- Assessment of potential toxicity [ Time Frame: 1 year ]Assessment of potential toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052882
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Gerald Soff, MD||Memorial Sloan Kettering Cancer Center|