Chemotherapy-induced ThrombocytopeniaPhase 3NCT06201663
Romiplostim in Chemotherapy-Induced Thrombocytopenia
A Phase 3 study testing Romiplostim in people with Chemotherapy-induced Thrombocytopenia and Solid Malignancy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia, Solid Malignancy
- What is being tested?
- Romiplostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2023to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical, histopathological features, and /or immunohistochemical staining.
- Patients with chemotherapy-induced thrombocytopenia defined as either
- severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level < 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.
- delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3 weeks from the first day of chemotherapy cycle administration or the previous dose was reduced by >20% due to low platelet count <100×10e9/L.
Who cannot join
- Patients with second primary neoplasm.
- Patients with relapsed/refractory solid malignancy.
- Presence of primary or metastatic liver cancer.
- History of a prior symptomatic venous thromboembolic event (VTE) or arterial ischemic events.
- Patients with thrombocytopenia due to other etiologies e.g., underlying inherited thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Children's Hospital
Cairo, 11566
Sara S Makkeyah, PhD, +201140105222, smakkeyah@med.asu.edu.eg
Reem M El-Mazloom, MSc, +201002488174, reem.mazloom@med.asu.edu.eg
About this study
Official title: Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy
Read the detailed description
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment.
Romiplostim is a potential agent that can improve platelet counts, allowing the resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing the nadir platelet counts thus improving dose intensity.
- Being tested
- Romiplostim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimDrug
Also called TPO-RA
Weekly subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients with CIT fulfilling the inclusion criteria will receive romiplostim subcutaneously weekly, either at the time of nadir of a delayed chemotherapy cycle or on the first day of the subsequent chemotherapy cycle and continue until the completion of chemotherapy for maximum 12 weeks.
Starting dose will be 3 μg/kg with the escalation of the dose weekly by 2 μg/kg (maximum dose 10 μg/kg) when the platelet increment was less than 25 x10e9/L to maintain platelet counts above 75x10e9/L. Receives: Drug: Romiplostim |
| Control group | No intervention | Patients with CIT fulfilling the inclusion criteria randomized to the control group will not receive romiplostim injections. Patients are allowed to received supportive care according to the standard of care protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic response
Platelet count increase to > 75 x 10e9/L, as well as toleration of chemotherapy resumption for at least 8 weeks or two cycles without subsequent chemotherapy dose reduction or dose delay because of recurrent CIT
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start17 Dec 2023
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201663
- Sponsor's protocol ID
- FAMSU MD343/2023
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy
- ClinicalTrials.gov ID
- NCT06201663
- Acronym / sponsor ID
- FAMSU MD343/2023
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy
Detailed description
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment.
Romiplostim is a potential agent that can improve platelet counts, allowing the resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing the nadir platelet counts thus improving dose intensity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: RomiplostimPatients with CIT fulfilling the inclusion criteria will receive romiplostim subcutaneously weekly, either at the time of nadir of a delayed chemotherapy cycle or on the first day of the subsequent chemotherapy cycle and continue until the completion of chemotherapy for maximum 12 weeks. Starting dose will be 3 μg/kg with the escalation of the dose weekly by 2 μg/kg (maximum dose 10 μg/kg) when the platelet increment was less than 25 x10e9/L to maintain platelet counts above 75x10e9/L. |
| Control group | No intervention | –Patients with CIT fulfilling the inclusion criteria randomized to the control group will not receive romiplostim injections. Patients are allowed to received supportive care according to the standard of care protocols. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical, histopathological features, and /or immunohistochemical staining.
- Patients with chemotherapy-induced thrombocytopenia defined as either
- severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level < 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.
- delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3 weeks from the first day of chemotherapy cycle administration or the previous dose was reduced by >20% due to low platelet count <100×10e9/L.
Key exclusion criteria (5 listed)
- Patients with second primary neoplasm.
- Patients with relapsed/refractory solid malignancy.
- Presence of primary or metastatic liver cancer.
- History of a prior symptomatic venous thromboembolic event (VTE) or arterial ischemic events.
- Patients with thrombocytopenia due to other etiologies e.g., underlying inherited thrombocytopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomiplostimAlso: TPO-RAWeekly subcutaneous injections | Drug | Interventional group |
Primary outcome
Hematologic response
Time frame: 12 weeks
Platelet count increase to > 75 x 10e9/L, as well as toleration of chemotherapy resumption for at least 8 weeks or two cycles without subsequent chemotherapy dose reduction or dose delay because of recurrent CIT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romiplostim in people with Chemotherapy-induced Thrombocytopenia and Solid Malignancy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.