Chemotherapy-induced ThrombocytopeniaPhase 3RECITENCT03362177
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
A Phase 3 study testing Romiplostim in people with Chemotherapy-induced Thrombocytopenia, run by Amgen at 117 sites in 20 countries.
Trial summary
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- What is being tested?
- Romiplostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 117 sitesin 20 countries
- Study dates
- 30 Sep 2019to 9 Jan 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent 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.
- Males or females greater than or equal to 18 years of age at signing of the informed consent.
- Histologically or cytologically confirmed diagnosis of gastrointestinal, pancreatic, or colorectal adenocarcinoma, defined as cancers of the esophagus (including esophagogastric junction [EGJ] cancer), stomach, pancreas, colon, or rectum. Tumor stage will not affect eligibility.
- Subjects must be receiving 1 of the following regimens: An oxaliplatin-based chemotherapy regimen, containing 5 FU or capecitabine plus oxaliplatin (irinotecan may be added for FOLFIRINOX or FOLFOXIRI) on a 14- or 21 day schedule, respectively; OR, subjects must have chemotherapy-induced thrombocytopenia from a non-protocol chemotherapy regimen, planning to start treatment with one of the protocol chemotherapy regimens which has been delayed greater than or equal to one week due to chemotherapy-induced thrombocytopenia. Note: Use of these regimens are permitted with (1) anti angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti epidermal growth factor receptor agents);
- Subjects must have a local platelet count ≤ 85 x 10^9/L on study day 1.
- Subjects must be at least 14 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if they received FOLFOX, FOLFIRINOX or FOLFOXIRI, and 21 days removed if they received CAPEOX.
- Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Who cannot join
- Previous or Current Medical Conditions
- Acute lymphoblastic leukemia.
- Acute myeloid leukemia.
- Any myeloid malignancy.
- Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
- Myeloproliferative disease.
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- Multiple myeloma.
- Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
- Major surgery ≤ 28 days or minor surgery ≤ 3 days prior to enrollment.
- New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be both stable and suitable for continued therapeutic anticoagulation during trial participation.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening.
- Evidence of active infection within 2 weeks prior to first dose of study treatment.
- Known human immunodeficiency virus infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results.
- Known active chronic hepatitis B or C infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results. Hepatitis B and C infection is based on the following results:
- Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
- Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
- Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
- Secondary malignancy within the past 5 years except:
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Adequately treated breast ductal carcinoma in situ without evidence of disease.
- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Malignancy treated with curative intent and with no known active disease present for at least 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
- Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
- Prior/Concomitant Therapy
- Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
- Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Diagnostic Assessments
- Anemia (hemoglobin <80 g/L [8 g/dL]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
- Neutropenia (absolute neutrophil count 1 x 10^9/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines.
- Abnormal renal function with creatinine clearance < 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
- Abnormal liver function (total bilirubin > 3 X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 X ULN for subjects without liver metastases or ≥ 5 X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
- Other Exclusions
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
- Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation.
- Males unwilling to use contraception* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation.
- If the male's sole partner is of non-childbearing potential, he is not required to use additional forms of contraception during the study.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional period of 6 months after treatment (and chemotherapy) discontinuation.
- Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation.
Trial locations and contacts
117 sites in 20 countries.
117 sites in 20 countries
United States22 sites
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
Mercy Medical Center
Baltimore, Maryland, 21202
American Oncology Partners, PA
Bethesda, Maryland, 20817
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, 81505
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
Saint Bernards Medical Center
Jonesboro, Arkansas, 72401
Morristown Medical Center
Morristown, New Jersey, 07960
University Medical Center New Orleans
New Orleans, Louisiana, 70112
University of California Irvine
Orange, California, 92868
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, 32763
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, 71105
Orchard Healthcare Research Inc
Skokie, Illinois, 60076
Regional Cancer Care Associates
Sparta, New Jersey, 78071
Medical Oncology Associates PS
Spokane, Washington, 99208
Oncology Hematology Associates
Springfield, Missouri, 65807
Oncology and Hematology Associates of West Broward, PA
Tamarac, Florida, 33321
Cleveland Clinic Florida
Weston, Florida, 33331
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Russia13 sites
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
Arkhangelsk, 163045
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
Kazan', 420029
Clinical hospital 2, Group of companies medsi
Moscow, 125284
Medsi Group
Moscow Region, 143442
LLC Tonus
Nizhny Novgorod, 603089
Omsk Regional Clinical Oncology Dispensary
Omsk, 644013
State budget institution of public health Pyatigorsk oncology dispensary
Pyatigorsk, 357502
State Institution of Public Health
Ryazan, 390011
Leningrad Regional Oncology Dispensary na L D Roman
Saint Petersburg, 191104
FSBI Scientific and Research Oncology Institute named after N N Petrov
Saint Petersburg, 197758
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
Sochi, 354057
State Institution of Public Health Tambov Regional Oncology Dispensary
Tambov, 390013
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
Ufa, 450054
Turkey (Türkiye)13 sites
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06200
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06560
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, 22030
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, 34093
Prof Dr Cemil Tascioglu Sehir Hastanesi
Istanbul, 34384
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Ege Universitesi Tip Fakultesi
Izmir, 35100
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
Kocaeli, 41380
VM Medical Park Samsun Hastanesi
Samsun, 55200
Greece7 sites
General Hospital of Athens Laiko
Athens, 11526
Aretaieio Hospital
Athens, 11528
Evgenidio Hospital I Agia Trias
Athens, 11528
Attikon University Hospital
Athens, 12462
General Oncology Hospital of Kifissia Agioi Anargyroi
Athens, 14564
University Hospital of Patras
Pátrai, 26504
Agios Loukas Clinic
Thessaloniki, 55236
Romania7 sites
Policlinica de Diagnostic Rapid
Brasov, 500152
Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation
Bucharest, 022328
Spitalul Clinic al Cailor Ferate Cluj Napoca
Cluj-Napoca, 400015
SC Medisprof SRL
Cluj-Napoca, 400124
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200347
Institutul Regional de Oncologie Iasi
Iași, 700483
SC Oncomed SRL
Timișoara, 300239
Brazil6 sites
Loema Instituto de Pesquisa Clinica e Consultores Ltda
Campinas, São Paulo, 13010-001
Centro de Pesquisa da Serra Gaucha - Cepesg
Caxias do Sul, Rio Grande do Sul, 95020-450
Instituto de Oncologia do Parana
Curitiba, Paraná, 80530-010
Catarina Pesquisa Clinica
Itajaí, Santa Catarina, 88301-220
Casa de Saude Santa Marcelina
São Paulo, São Paulo, 08270-120
Vencer e Oncoclinica
Teresina, Piauí, 64049-200
Spain6 sites
Hospital Clinico Universitario San Cecilio
Granada, Andalusia, 18016
Hospital Universitario Arnau de Vilanova Lleida
Lleida, Catalonia, 25198
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005
Hospital Universitari Sant Joan de Reus
Reus, Catalonia, 43204
Hospital Clinico Universitario de Salamanca
Salamanca, Castille and León, 37007
Portugal5 sites
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Porto, 4099-001
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
Porto, 4200-319
Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real
Vila Real, 5000-508
Argentina4 sites
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS
Instituto Oncologico Cordoba
Córdoba, Córdoba Province, 5003
Centro de Diagnostico Investigacion y Tratamiento
Salta, 4400
Centro de Investigaciones Clínicas Clínica Viedma
Viedma, Río Negro Province, 8500
France4 sites
Centre Hospitalier Universitaire de Brest
Brest, 29609
Hôpital Européen Georges Pompidou
Paris, 75015
Hopital Foch
Suresnes, 92150
Institut Gustave Roussy
Villejuif, 94805
Hungary4 sites
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6720
Mexico4 sites
Oncotech
La Paz, Baja California Sur, 23040
Centro Medico Nacional Siglo XXI
México, 06720
Oaxaca Site Management Organization SC
Oaxaca City, 68000
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
San Luis Potosí City, San Luis Potosí, 78200
Poland4 sites
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, 21-500
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
Brzeziny, 95-060
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-780
Bulgaria3 sites
Complex Oncology Center - Ruse EOOD
Rousse, 7002
Medical Center Nadezhda Clinical EOOD
Sofia, 1330
Specialized Hospital for Active Treatment of Oncology EAD
Sofia, 1756
Colombia3 sites
Centro Medico Imbanaco
Cali, Valle del Cauca Department, 760042
Fundacion Colombiana de Cancerologia Clinica Vida
Medellín, Antioquia, 050030
Oncomedica Imat
Montería, Departamento de Córdoba, 230002
Italy3 sites
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, 10126
Ukraine3 sites
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
Chernivtsi, 58013
Prykarpatskyy Clinical Oncology Centre
Ivano-Frankivsk, 76018
Transcarpathian Regional Clinical Oncological Dispensary
Uzhhorod, 88000
Austria2 sites
Landeskrankenhaus Steyr
Steyr, 4400
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Canada2 sites
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, N2G 1G3
Cape Breton Cancer Centre, Nova Scotia Health Authority
Sydney, Nova Scotia, B1P 1P3
About this study
Official title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
Read the detailed description
RECITE: A phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- Romiplostim, Placebo
- Keywords
- Chemotherapy Induced Thrombocytopenia, Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimBiological
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim | Experimental | Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. Receives: Biological: Romiplostim |
| Placebo | Placebo comparator | Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had Thrombocytopenia-induced Dose Modification
Participants met the criteria of the primary endpoint if there was no thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-trial chemotherapy regimen (cycles were up to 3 weeks).
A thrombocytopenia-induced modification was defined as any dose reduction, dose delay, dose omission, and/or early chemotherapy treatment discontinuation due to low platelet counts less than 100 x 10^9/L.
The 95% confidence interval (CI) is based on the exact Clopper-Pearson method.
Measured: Day 1 up to Week 12
Secondary outcomes (9)
Platelet Count Nadir at the End of the Treatment Period
The platelet count nadir from the first on-trial chemotherapy through the end of the treatment period is presented. The least squares (LS) mean platelet count nadirs were estimated using a general linear model which included treatment, stratification factors, and the interaction between treatment and the stratification factors (tumor type and baseline platelet count).
Measured: Up to 21 weeks
Kaplan-Meier Estimate of Time to First Platelet Response
Platelet response was defined as achieving a platelet count of ≥ 100 x 10^9/L in the absence of platelet transfusions during the preceding 7 days.
Participants who did not achieve a response event during the treatment period were censored at their last platelet count assessment up to end of treatment period or at the randomization date if they did not have any post-baseline platelet assessments.
Measured: Up to 21 weeks
Duration-adjusted Event Rate of Bleeding Events in the Treatment Period
The duration-adjusted adverse event (AE) incidence rate was the number of events per 100 subject-years from the trial day 1 until the date of last dose of investigational product + 30 days, or end of trial, whichever is earlier.
It was calculated as: duration-adjusted event rate per 100 subject years (n/Subj-yr) x 100.
The duration-adjusted event rate was assessed for Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 bleeding events. CTCAE grading for AEs ranges from Grade 1 (mild) to Grade 5 (death related to AE). Grade 2 AEs were moderate.
Measured: Up to 21 weeks
Overall Survival
Overall survival was defined as the time calculated from trial Day 1 to death. Participants who did not died were censored.
Measured: From Day 1 up to 1 year after last dose of investigational product (IP) (max 1869 days)
Percentage of Participants Who Had Platelet Transfusions During the Treatment Period
Participants who had at least 1 platelet transfusion during the treatment period.
Measured: Up to 21 weeks
Percentage of Participants Who Achieved a Platelet Count ≥ 100 x 10^9/L
The number of participants who achieved a platelet count ≥ 100 x 10^9/L at any time after trial Day 1 to Week 4 (7 days after the planned third dose of IP). If a platelet transfusion occurred during the 7 days preceding a platelet count, then that platelet count was not considered as achieving the endpoint even if it is ≥ 100 x 109/L. Participants who had no platelet counts during this period were considered as not achieving achieved a platelet count ≥ 100 x 109/L. For participants who never received IP, the participants are considered as not achieving a platelet count ≥ 100 x 109/L. Weeks with no platelet count measurements (missing data) were considered as not achieving a platelet count ≥ 100 x 109/L.
Measured: Day 1 to Week 4
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Fatal AEs
An AE was defined as any untoward medical occurrence in a clinical trial participant.
A TEAE was an AE that started on or after the first dose of IP up to 30 days after the end of investigational product or last dose of on-trial chemotherapy (up to 3 cycles), whichever occurs later. Clinically significant changes in laboratory values were considered AEs.
A SAE was defined as any untoward medical occurrence that, met at least 1 ofthe following criteria: resulted in death (fatal), immediately life-threatening,required in-patient hospitalization or prolongation of existing hospitalization,resulted in persistent or significant disability/incapacity or was a congenitalanomaly/birth defect.
Measured: From first dose of IP to 30 days after last dose of IP: median (min, max) duration was 86.0 (31.0, 184.0) days
Number of Participants Who Developed Anti-romiplostim Antibodies and Anti-thrombopoietin (TPO) Antibodies
Blood samples were collected from all participants for the measurement of anti-romiplostim and anti-TPO binding antibodies. Participants were tested for the presence of anti-romiplostim and anti-TPO antibodies at baseline (pre-existing antibody) and post-baseline (developed antibody). Samples testing positive for binding antibodies were also be tested for neutralizing antibodies.
Measured: Up to 21 weeks
Number of Participants Who Reported Myelodysplastic Syndromes (MDS) and SecondaryMalignancies
Events were identified using narrow search of pre-defined list of preferred terms for myelodysplastic syndromes (SMQ). Secondary malignancies included progression from myelodysplastic syndrome to acute myeloid leukemia (AML).
Measured: From Day 1 up to 1 year after last dose of IP (max 1869 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start30 Sep 2019
- Primary completion25 Jan 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362177
- Sponsor's protocol ID
- 20140346
- Other IDs
- 2017-002992-25, 75A50119C0061, 2017
- Acronym
- RECITE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2017
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
Al-Samkari H, Munoz C, Geredeli C, Korantzis I, Gonzalez Astorga B, Arslan C, Cordeiro Camargo JF, Scotte F, Borges G, Wang K, Eisen M, Kuter DJ, Soff GA. Romiplostim versus Placebo for Chemotherapy-Induced Thrombocytopenia. N Engl J Med. 2026 Mar 12;394(11):1061-1073. doi: 10.1056/NEJMoa2511882.
PubMed 41812193