Trial record 14 of 66 for:
Recruiting Studies | Immune Thrombocytopenia
Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia (RODEX)
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| ClinicalTrials.gov Identifier: NCT05325593 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2022
Last Update Posted : April 28, 2023
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Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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Brief Summary:
Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Immune Thrombocytopenia | Drug: romiplostim plus dexamethasone Drug: Dexamethasone | Phase 3 |
The main objective of the study is to evaluate the superiority of romiplostim plus dexamethasone versus dexamethasone alone in the treatment of primary immune thrombocytopenia, with sustained response to any ITP treatment and without World Health Organization grade 2 or higher bleeding, after six months from cessation of treatment.
Maximum time on treatment with romiplostim will be 12 months (365 days). Then, patients will be followed up for 6 additional months (180 days) after stopping romiplostim.
Clinical rules are included if romiplostim dose should be modified or finished. In case of dexamethasone, no dose adjustment is permitted.
The evaluation of romiplastim plus dexamethasone´s superiority in different periods and platelet count, proportion of patients with complete response (CR), global response (GR), early response (ER) and initial response (IR); time to loss of response (LoR), adverse events, quality of life and healthcare resources use are included as secondary objectives.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 126 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel Assignment Randomized 1:1 |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia |
| Actual Study Start Date : | December 2, 2022 |
| Estimated Primary Completion Date : | May 2025 |
| Estimated Study Completion Date : | May 2026 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dexamethasone
Dexamethasone sodium phosphate
Dexamethasone acetate
Romiplostim
| Arm | Intervention/treatment |
|---|---|
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Experimental: romiplostim plus dexamethasone (ROM + DEX)
Dexamethasone 40 mg daily x 4 days only in the first cycle and subcutaneous romiplostim weekly for up to 12 months Romiplostim:
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Drug: romiplostim plus dexamethasone
Patients will be reviewed weekly for 8 weeks (56 days). After Week 8, patients will be reviewed every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.
Other Name: ROM + DEX |
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Active Comparator: Dexamethasone (DEX)
Dexamethasone 40 mg daily x 4 days for up to 3 cycles every 14 to 28 days
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Drug: Dexamethasone
Patients will be reviewed weekly until the completion of dexamethasone cycles and for a minimum of 8 weeks (56 days). After that, every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.
Other Name: DEX |
Primary Outcome Measures :
- Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment) [ Time Frame: 180 days after treatment withdrawal ]Proportion of patients with platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without World Health Organization grade 2 or more bleeding
Secondary Outcome Measures :
- Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months in the absence of any ITP treatment including any rescue treatment. [ Time Frame: 180 days after treatment withdrawal ]Proportion of patients with platelets higher or equal than 30x109/L in the absence of any ITP treatment including any rescue treatment for at least 6 consecutive months (≥180 days) from treatment cessation and without World Health Organization grade 2 or more bleeding.
- Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 12 months in the absence of any ITP treatment including any rescue treatment. [ Time Frame: 365 days after treatment withdrawal ]Proportion of patients with platelets higher or equal than 30x109/L in the absence of any ITP treatment including any rescue treatment for at least 12 consecutive months (≥365 days) from treatment cessation and without World Health Organization grade 2 or more bleeding.
- Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 50x109/L for 12 months in the absence of any ITP treatment including any rescue treatment. [ Time Frame: 365 days after treatment withdrawal ]Proportion of patients with platelets higher or equal than 50x109/L in the absence of any ITP treatment including any rescue treatment for at least 12 consecutive months (≥365 days) from treatment cessation and without World Health Organization grade 2 or more bleeding.
- Proportion of patients with early response (ER) [ Time Frame: Day 7 ]Proportion of patients with platelet count higher or equal than 30x109/L and at least double than baseline.
- Proportion of patients with initial response (IR) [ Time Frame: Day 30 ]Proportion of patients with platelet count higher or equal than 30x109/L
- Proportion of patients with complete response (CR) [ Time Frame: Day 180, Day 365, Day 545 ]Patients with platelet count ≥100x109/L and absence of bleeding symptoms.
- Proportion of patients with response (R) [ Time Frame: Day 180, Day 365, Day 545 ]Patients with platelet count between 100x109/L and 30x109/L and at least doubled from baseline and absence of bleeding symptoms.
- Proportion of patients with global response (GR) [ Time Frame: Day 180, Day 365, Day 545 ]Patients with platelet count ≥100x109/L and absence of bleeding symptoms or platelet count between 100x109/L and 30x109/L and at least doubled from baseline and absence of bleeding symptoms.
- Proportion of patients with targeted range (TR) [ Time Frame: Day 180, Day 365, Day 545 ]Patients with platelet count between ≥30x109/L and ≤400x109/L.
- Time to loss of response (LoR) in patients who achieved response in both arms. [ Time Frame: In every study visit, assessed up to 545 days ]Number of days from the first time the patient achieved a platelet count ≥30x109/L until platelet count dropped below 30x109/L measured on 2 occasions with more than 1 day apart or presence of bleeding
- Proportion of patients requiring any rescue treatment [ Time Frame: In every study visit, assessed up to 545 days ]Proportion of patients who need rescue treatments in each arm and total patients
- Proportion and time to treatment failures [ Time Frame: In every study visit, assessed up to 545 days ]Proportion of patients who need rescue treatments and And the number of days they needed treatment
- Proportion of patients with adverse events (AEs), including serious adverse events (SAEs) and laboratory safety parameters. [ Time Frame: In every study visit, assessed up to 545 days ]AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Bleeding events will be carefully monitored
- Changes in patients bleeding [ Time Frame: Screning, Day 1, Week 8, Week 12, Moth 6, Moth 12 and End of study Visit ]For the assessment of the of the patients' bleeding will be used immune thrombocytopenia-bleeding assessment tool (ITP-BAT): bleeding signs/symptoms are grouped in three domains (skin, visible mucosae and organs) and is graded from 0 (No) to 4.
- Changes in patients' quality of life- Short Form-36 Health Survey [ Time Frame: Day 1, Week 8, Day 180, Day 365 and Day 545 ]For the assessment of the quality of life during the study will be used Short-Form-36 Health Survey: is a 36-item scale constructed to survey health-related 8 domains: limitations in physical activities due to health problems; limitations in social activities due to physical or emotional problems; limitations unusual role activities due to physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations unusual role activities due to emotional problems; vitality (energy and fatigue); and general health perceptions.
- Changes in patients' quality of life- FACIT-F [ Time Frame: Day 1, Week 8, Day 180, Day 365 and Day 545 ]For the assessment of the quality of life during the study will be used FACIT-F (Fatigue Scale): is a short scale, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week.The level of fatigue is measured by recording item responses ona 4-point Likert scale ranging from 0 "not at all" to 4 "very much.
- Changes in patients' quality of life- ITP-Patient Assessment Questionnaire [ Time Frame: Day 1, Week 8, Day 180, Day 365 and Day 545 ]For the assessment of the quality of life during the study will be used ITP-Patient Assessment Questionnaire): is a disease-specific instrument that was designed to measure the QoL of adult patients with immune thrombocytopenia. The instrument comprises 38 items completed by male respondents and 44 items completed by female respondents.
- Healthcare resources use (HRU) [ Time Frame: In every study visit, assessed up to 545 days ]
The data collected may be used to conduct exploratory economic analyses and may include:
- Number of outpatient visits,
- Number of home health care
- Number of Hospitalization
- Duration of medical care visits (days)
- Number of Emergency room visits
- Number of diagnostic procedures
- Number of medical care visits
- Loss of productivity [ Time Frame: In every study visit, assessed up to 545 days ]Number of days of absenteeism from school or work and associated cost
- Maximum number of consecutive days with platelet response [ Time Frame: In every study visit, assessed up to 545 days ]- The maximum number of consecutive days with platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
- Maximum number of consecutive days with platelet complete response (CR) [ Time Frame: In every study visit, assessed up to 545 days ]- The maximum number of consecutive days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
- Maximum number of consecutive days with platelet global response (GR) [ Time Frame: In every study visit, assessed up to 545 days ]The maximum number of consecutive days with platelet count ≥100x109/L or platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
- Maximum number of consecutive days with platelet targeted range (TR) [ Time Frame: In every study visit, assessed up to 545 days ]The maximum number of consecutive days with platelet count between ≥30x109/L and ≤400x109/ L in the total sample and in the absence of any rescue treatment
- Total number of days with platelet response [ Time Frame: In every study visit, assessed up to 545 days ]The total number od days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
- Total number of days with platelet complete response (CR) [ Time Frame: In every study visit, assessed up to 545 days ]The total number od days with platelet count ≥100x109/L in the total sample and in the absence of any rescue treatment
- Total number of days with platelet global response (GR [ Time Frame: In every study visit, assessed up to 545 days ]The total number od days with platelet count ≥100x109/L or platelet count between 100x109/L and 30x109/L in the total sample and in the absence of any rescue treatment
- Total number of days with platelet targeted range (TR) [ Time Frame: In every study visit, assessed up to 545 days ]The total number od days with platelet count between ≥30x109/L and ≤400x109/ L in the total sample and in the absence of any rescue treatment
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Main inclusion criteria:
- Age ≥ 18 years of age at the time of signing informed consent.
- Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP.
- Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms.
- Serum creatinine concentration ≤1.5 mg/dL.
Main exclusion criteria:
- World Health Organization's performance status >2.
- Previous therapy with rituximab (within 3 months previous of study enrollment), corticosteroids or, therapy with other immunomodulating agents within 1 month before of enrolment;,prior use of hematopoietic analogs and or fostamatinib for any other reason despite ITP three months before enrolment.
- Previous use of romiplostim, polyethylene glycol-recombinant human megakaryocyte growth and development factor, Eltrombopag, recombinant human anti-thrombopoietin, or any platelet-producing agent three months before enrolment.
- Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study.
- Splenectomy within 3 months of the screening visit or planned splenectomy during study period.
- Abnormal renal function (serum creatinine > 1.5 mg/dL).
- Active hepatic disease (evidenced by alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal (it will only be necessary to determine one of the two transaminases
- Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- Patients with known immunoglobulin M seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month.
- Patients with an active viral infection at screening with: Hepatitis B Virus, Hepatitis C Virus, detectable virus charge of HIV.
- Intolerance to dexamethasone.
- History of a bone marrow stem cell disorder.
- Active or prior malignancy except adequately treated (ie, complete surgical excision with negative margins) basal cell carcinoma.
- History of helicobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available.
- History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia.
- History of antiphospholipid antibody syndrome.
- History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disease in the last 6 months.
- Hypersensitivity to any recombinant Escherichia coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune) or known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study or < 30 days since ending another investigational device or drug studies, or receiving other investigational agents.
- Will have any other investigational procedures performed while enrolled in this clinical study.
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment.
- Female subject of childbearing potential is not willing to use, in combination with her partner, an acceptable method of effective contraception during treatment and for 1 month after the end of treatment. Females of childbearing potential should only be included after a negative, pregnancy test.
- Will not be available for protocol-required study visits, to the best of the subject's and investigator's knowledge.
- Any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
- Other serious comorbidities at investigator criteria.
Information from the National Library of Medicine
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): NCT05325593
Contacts
| Contact: Clara M Rosso Fernández, MD-PhD | +34955013414 | claram.rosso.sspa@juntadeandalucia.es | |
| Contact: María Eva Mingot Castellano, Hematologist | +34607933071 | memingot@gmail.com |
Locations
| Spain | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain, 08003 | |
| Contact: Blanca Sánchez González | |
| Contact bsanchezgonzalez@parcdesalutmar.cat | |
| Centre Sociosanitari Sant Jordi de la Vall D'Hebron | Not yet recruiting |
| Barcelona, Spain, 08035 | |
| Contact: David Valcarcel Ferreiras | |
| Contact dvalcarcel@vhio.net | |
| Complejo Asistencial Universitario de Burgos | Recruiting |
| Burgos, Spain, 09006 | |
| Contact: Tomás González López tjgonzalez@saludcastillayleon.es | |
| Complejo Hospitalario Universitario A Coruña | Not yet recruiting |
| Coruña, Spain, 15006 | |
| Contact: Fernanda López Fernández maria.Fernanda.Lopez.Fernandez@sergas.es | |
| Hospital Universitario Virgen de las Nieves | Not yet recruiting |
| Granada, Spain, 18014 | |
| Contact: Laura Entrena Ureña laura_eu@hotmail.com | |
| Hospital General Universitario Gregorio Marañón | Not yet recruiting |
| Madrid, Spain, 28007 | |
| Contact: Cristina Pascual Izquierdo crisizquierdo3@yahoo.es | |
| Compejo Hospitalario La Paz | Not yet recruiting |
| Madrid, Spain, 28046 | |
| Contact: María Teresa Álvarez Román talvarezroman@gmail.com | |
| Hospital Universitario Fundación Alcorcon | Not yet recruiting |
| Madrid, Spain, 28922 | |
| Contact: Francisco Peñalver Párraga | |
| Contact franciscojavier.penalver@salud.madrid.org | |
| Hospital Universitario Morales Meseguer | Recruiting |
| Murcia, Spain, 3008 | |
| Contact: María Luisa Lozano Almela mllozano@um.es | |
| Hospital Clínico Universitario Virgen de la Arrixaca | Not yet recruiting |
| Murcia, Spain, 30120 | |
| Contact: Pedro Rosique Cortina prosiquec@hotmail.com | |
| Hospital Universitario Virgen de la Victoria | Recruiting |
| Málaga, Spain, 29010 | |
| Contact: Isabel Socorro Caparrós Miranda cmisabelsocorro@hotmail.com | |
| Complejo Asistencial Son Espases | Recruiting |
| Palma De Mallorca, Spain, 07120 | |
| Contact: Mariana Canaro Himyk mcanaro@gmail.com | |
| Complejo Asistencial Universitario de Salamanca | Not yet recruiting |
| Salamanca, Spain, 37007 | |
| Contact: José Ramón González Porras jrgp@usal.es | |
| Hospital Universitario Virgen del Rocío | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact: María Eva Mingot Castellano mariae.mingot.sspa@juntadeandalucia.es | |
| Hospital Universitario y Pilitécnico La Fe | Not yet recruiting |
| Valencia, Spain, 46026 | |
| Contact: Isidro Jarque Ramos jarque_isi@gva.es, ijarqueramos@gmail.com | |
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
| Principal Investigator: | Charlotte Bradbury | Centre for Trials Research College of Biomedical & Life Sciences Cardiff University |
| Responsible Party: | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| ClinicalTrials.gov Identifier: | NCT05325593 |
| Other Study ID Numbers: |
RODEX 2021-006970-22 ( EudraCT Number ) |
| First Posted: | April 13, 2022 Key Record Dates |
| Last Update Posted: | April 28, 2023 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Along the study |
| Access Criteria: | Direct collaborators within the study |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
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Romiplostim Dexamethasone |
Additional relevant MeSH terms:
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Thrombocytopenia Immune System Diseases Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Hemorrhage Pathologic Processes Skin Manifestations Dexamethasone |
Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |