NCT05521204 Olverembatinib for FGFR1-rearranged Neoplasms
| NCT ID | NCT05521204 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Myeloproliferative Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2024-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-09-01 with a primary completion date of 2024-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare hematologic malignancy with very poor outcome despite intensive chemotherapy. The only curative option is thought to be allogeneic hematopoietic stem cell transplantation (HSCT) in remission. This phase II study is aimed to evaluate the efficacy of Olverembatinib, consolidated with HSCT in the treatment of FGFR1-rearranged myeloid/lymphoid neoplasm.
Eligibility Criteria
Inclusion Criteria: 1. Patients with newly diagnosed, progressed or relapsed myeloid/lymphoid neoplasms with FGFR1 rearrangement according to the WHO-2016 diagnostic criteria. Patients who have received allogeneic hematopoietic stem cell transplantation or ponatinib should be excluded. 2. ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points. 3. Expected survival period ≥12 weeks. 4. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: 1. Patients who have received allogeneic hematopoietic stem cell or ponatinib. 2. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive). 3. Patients who are pregnant, planning to become pregnant or breastfeeding. 4. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures. 5. Patients who suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Contact & Investigator
Suning Chen
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT05521204 clinical trial?
This trial is open to participants of all sexes, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05521204 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05521204 currently recruiting?
Yes, NCT05521204 is actively recruiting participants. Contact the research team at chensuning@sina.com for enrollment information.
Where is the NCT05521204 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05521204 clinical trial?
NCT05521204 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Suning Chen at First Affiliated Hospital of Soochow University. The trial plans to enroll 20 participants.