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Romiplostim for Low Platelet Count in Cancer (RECITE Trial)
RECITE Trial Summary
This trial is testing a drug to see if it can help people with cancer who have low blood platelet counts from their chemotherapy.
RECITE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRECITE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 3 trial • 313 Patients • NCT00116688RECITE Trial Design
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Who is running the clinical trial?
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- I am able to care for myself and perform daily activities.I have acute lymphoblastic leukemia.I finished my last chemotherapy cycle at least 14 or 21 days ago, depending on the type.I have at least 3 chemotherapy sessions left.I have been diagnosed with multiple myeloma.I am on or starting a specific chemotherapy plan for my cancer.I have a type of blood cancer affecting my bone marrow.I have not had an infection in the last 2 weeks.My kidney function is low, with a creatinine clearance rate of at least 30 mL/min.I haven't had serious heart issues like heart failure or a heart attack in the last 4 months.I have not had major surgery in the last 28 days or minor surgery in the last 3 days.I am not pregnant or breastfeeding and do not plan to during or for 6 months after treatment.I agree to use contraception during and 6 months after treatment.I agree to use contraception or practice abstinence during and for 6 months after my treatment.My cancer is in the esophagus, stomach, pancreas, colon, or rectum.I have been diagnosed with HIV.My white blood cell count is low, but I can receive treatment to increase it.I have used medications to increase my platelet count before.I have anemia with hemoglobin levels below 8 g/dL.I agree not to donate sperm during and for 6 months after treatment.I have myelodysplastic syndrome but haven't necessarily had a bone marrow biopsy.I have had a stable blood clot and been on blood thinners for at least 14 days.My liver tests are much higher than normal.I am 18 years or older and have signed the informed consent.I have an active hepatitis B or C infection.I haven't had cancer, except for specific types treated over 5 years ago.I am not willing to use effective birth control during and 6 months after treatment.I have had a stroke or mini-stroke in the last 6 months.I have a disorder that affects my blood cells.I have acute myeloid leukemia.
- Group 1: Romiplostim
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project require all participants to be under the age of 50?
"Eligibility for this research study requires that patients are aged 18 to 100. Out of the 1,046 total clinical trials taking place, 56 are geared towards those under 18 and 990 are for seniors."
Are there any vacancies in this clinical trial for new patients?
"According to the latest update on clinicaltrials.gov, this trial is still recruiting patients. The post was made on September 30th, 2019 and updated October 26th, 2022."
What is the regulatory status of Romiplostim in the United States?
"Romiplostim has received a score of 3 for safety. This is because it is in Phase 3 trials, which suggests that not only is there some evidence of efficacy, but also multiple rounds of data affirming its safety."
Are there any other notable experiments that have been conducted with Romiplostim?
"Bergen's Memorial Sloan Kettering was the first to study romiplostim in 2014. So far, there have been 18317 completed trials and 9 more are presently recruiting patients. A large portion of these studies take place in Shreveport, Louisiana."
Where are the facilities that are participating in this research project located?
"There are 15 sites participating in this study, including CHRISTUS Highland Cancer Treatment Center in Shreveport, American Oncology Partners of Maryland, PA in Bethesda, Pacific Cancer Medical Center Inc in Anaheim, and other locations."
How can I sign up for the clinical trial?
"This clinical trial is looking for 162 patients with colorectal cancer who are between 18 and 100 years old. Applicants must meet the following criteria: They must have given informed consent prior to any study-specific activities or procedures, or their legally acceptable representative has done so in cases where the applicant cannot do so themselves due to a condition that, in the opinion of the investigator, may compromise their ability to give informed consent. Additionally, they must be male or female, and greater than or equal to 18 years of age at signing of the informed consent. Furthermore, they must have a histologically or cytologically confirmed diagnosis of"
Has this research been done before?
"Clinical research surrounding Romiplostim dates back to 2014. After the first successful trial involving 60 patients, Amgen sponsored a Phase 2 drug approval in 2014. Presently, 9 active studies are conducted in 62 cities and 23 countries."
How many individuals are being research subjects in this trial?
"That is correct, the information available on clinicaltrials.gov verifies that this study is still looking for patients to enroll. The trial was first posted on September 30th, 2019 and has since been updated October 26th, 2020. In total, they are looking for 162 individuals across 15 sites."
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