Myeloproliferative NeoplasmPhase 2NCT05521204
Olverembatinib for FGFR1-rearranged Neoplasms
A Phase 2 study testing Olverembatinib in people with Myeloproliferative Neoplasm and Acute Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myeloproliferative Neoplasm, Acute Leukemia
- What is being tested?
- Olverembatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points.
- Expected survival period ≥12 weeks.
- Willingness and ability to comply with study procedures and follow-up examination.
Who cannot join
- Patients who have received allogeneic hematopoietic stem cell or ponatinib.
- Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
- Patients who are pregnant, planning to become pregnant or breastfeeding.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Suning Chen, PhD, +8613814881746, chensuning@sina.com
About this study
Official title: A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement
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.
Read the detailed description
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare and highly heterogeneous hematological malignancy, mainly manifested as myeloproliferative neoplasms (MPNs) or acute leukemia, including T cells or B cells Cell lymphoblastic leukemia/lymphoma (T-cell or B-cell-ALL/LBL), acute myeloid leukemia (AML) and mixed cell leukemia (MPAL).
To date, there is no standard treatment. Conventional chemotherapy is frequently ineffective. The only curative option is thought to be allogeneic HSCT at present, TKIs may offer a therapeutic alternative in patients not eligible for allogeneic HSCT or to bridge the time between diagnosis and allogeneic HSCT.
Third-generation TKIs Olverembatinib is a pan- FGFR1 kinase inhibitor, and is supposed to be effective to achieve bone marrow remission in FGFR1-rearranged myeloid/lymphoid neoplasms.
- Conditions
- Myeloproliferative Neoplasm, Acute Leukemia
- Being tested
- Olverembatinib
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlverembatinibDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: Olverembatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The proportion of participants who achieve Overall Response (ORR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement
Measured: Assessed at protocol-defined timepoints through end of study, up to approximately 48 months.
Secondary outcomes (3)
Event-free survival (PFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Measured: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years.
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
Measured: From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Measured: Up to approximately 2 to 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Suning Chen, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521204
- Sponsor's protocol ID
- SZ-FGFR1
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Olverembatinib in the Treatment of Myeloid/Lymphoid Tumors With FGFR1 Rearrangement
- ClinicalTrials.gov ID
- NCT05521204
- Acronym / sponsor ID
- SZ-FGFR1
- Conditions
- Myeloproliferative Neoplasm, Acute Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 30 Aug 2022 (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.
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.
Detailed description
FGFR1-rearranged myeloid/lymphoid neoplasms are a rare and highly heterogeneous hematological malignancy, mainly manifested as myeloproliferative neoplasms (MPNs) or acute leukemia, including T cells or B cells Cell lymphoblastic leukemia/lymphoma (T-cell or B-cell-ALL/LBL), acute myeloid leukemia (AML) and mixed cell leukemia (MPAL).
To date, there is no standard treatment. Conventional chemotherapy is frequently ineffective. The only curative option is thought to be allogeneic HSCT at present, TKIs may offer a therapeutic alternative in patients not eligible for allogeneic HSCT or to bridge the time between diagnosis and allogeneic HSCT.
Third-generation TKIs Olverembatinib is a pan- FGFR1 kinase inhibitor, and is supposed to be effective to achieve bone marrow remission in FGFR1-rearranged myeloid/lymphoid neoplasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Olverembatinib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points.
- Expected survival period ≥12 weeks.
- Willingness and ability to comply with study procedures and follow-up examination.
Key exclusion criteria (5 listed)
- Patients who have received allogeneic hematopoietic stem cell or ponatinib.
- Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
- Patients who are pregnant, planning to become pregnant or breastfeeding.
- 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.
- 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.
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 |
|---|---|---|
| OlverembatinibGiven PO | Drug | Treatment Group |
Primary outcome
Overall Response Rate
Time frame: Assessed at protocol-defined timepoints through end of study, up to approximately 48 months.
The proportion of participants who achieve Overall Response (ORR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement
3 secondary outcomes
Event-free survival (PFS)
Time frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 to 4 years.
Overall survival (OS)
Time frame: From the first day of treatment to time of death from any cause, assessed up 2 to 4 years.
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 to 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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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.
Suning Chen principal investigator
First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olverembatinib in people with Myeloproliferative Neoplasm and Acute Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 30 Aug 2022. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suning Chen (+86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Assessed at protocol-defined timepoints through end of study, up to approximately 48 months.). 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 30 Aug 2022.