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New treatment option for Secondary AML
Official title A Study of Rebecsinib for Patients With Relapsed/Refractory Secondary Acute Myeloid Leukemia or High Risk Myelofibrosis
ClinicalTrials.gov ID: NCT07250646
What this study is testing
What is rebecsinib?
rebecsinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for secondary aml.
Also referred to as 17S-FD-895.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to test the safest and most effective dose of a new investigational drug, rebecsinib. Participants in this study will have either Secondary Acute Myeloid Leukemia (sAML) that has either returned (relapsed) or not responded to treatment (refractory) or have higher risk Myelofibrosis (MF).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and the willingness to sign a written informed consent.
- Must have a refractory myeloid neoplasm (5th Edition WHO Classification of Tumors) consisting of secondary AML (sAML), which has evolved from...
- Calculated Creatinine clearance (CrCl) \> 60 mL/min (based upon the Cockcroft- Gault Equation [CrCl = (140-age) \ ideal body wt (in kg) \ (0.85 if...
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
- people must be aged 18 years or older.
You likely can't join if
- Pregnant or breast feeding females are excluded.
- Previous hematopoietic cell transplant.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., HMA therapy, chemotherapy, immunotherapy) or participation in any investigational drug treatment within 2...
- Current infection requiring systemic antibiotics.
- Active infection with HIV, HBV, or HCV.
See the full eligibility criteria
- Ability to understand and the willingness to sign a written informed consent.
- Must have a refractory myeloid neoplasm (5th Edition WHO Classification of Tumors) consisting of secondary AML (sAML), which has evolved from antecedent MDS, MPN, MDS/MPN, or have higher-risk MF defined by DIPSS Plus or...
- Calculated Creatinine clearance (CrCl) \> 60 mL/min (based upon the Cockcroft- Gault Equation [CrCl = (140-age) \ ideal body wt (in kg) \ (0.85 if female) / (72 \ Cr)]. Estimate Ideal body weight in (kg) Males: IBW = 50...
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
- people must be aged 18 years or older.
- Both men and women of all races and ethnic groups are eligible for this trial.
- Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women must agree...
- Women of child-bearing potentialmust have a negative serum or urine pregnancy test.
- For sAML and high risk MF, at relapse must have ≥5% leukemic bone marrow blasts.
- people must have an ECOG performance status of 0-2.
- Hemoglobin ≥ 8.0 g/dL. This is to alleviate immediate concomitant need for transfusion via institutional guidelines for transfusion for symptomatic anemia.
- Total bilirubin ≤ 1.5 times upper limit of normal.
- ALT and AST ≤ 1.5 times upper limit of normal
- Prothrombin time international normalized ratio (INR) ≤ 2; AND Partial thromboplastin time ≤ 1.66 times upper limit of normal.
- Pregnant or breast feeding females are excluded.
- Previous hematopoietic cell transplant.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., HMA therapy, chemotherapy, immunotherapy) or participation in any investigational drug treatment within 2 weeks or 5-half lives, whichever is more, of initiation of rebecsinib...
- Current infection requiring systemic antibiotics.
- Active infection with HIV, HBV, or HCV.
- Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ or localized non-melanoma skin cancer).
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia or immune thrombocytopenia.
- Known uncompensated hypothyroidism (defined as TSH greater than 2x upper limit of normal not treated with replacement hormone).
- Insufficient recovery from surgery-related wound healing.
- Impaired cardiac function including any of the following:
- Myocardial infarction within 6 months of starting study drug;
- A past medical history of clinically significant ECG abnormalities, including QTc 470 msec or greater.
- Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- A QT -\>470 msec on ECG.
- On medication that is an inducer or inhibitor of CYP3A4, CYP2C9, CYP2C19, CYP2B6 and hepatic uptake transporters (e.g. OATP1B1/3, OAT1/2 OCT 1/2), or is metabolized by CYP2C9, 2C19, and 2B6. If they are an inducer or...
- Patients who in the opinion of the investigator may be unable to comply with the safety monitoring requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Sacramento, California, United States
- San Diego, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Sacramento, California, United States; San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.