BridgeMD
New treatment option for Myeloid Malignancies
Official title A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
ClinicalTrials.gov ID: NCT06668584
What this study is testing
What is Olutasidenib?
Olutasidenib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for myeloid malignancies.
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 goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Diagnosis of AML, MDS, MPN, or CMML according to World Health Organization (WHO) classification that underwent first or second alloSCT regardless of...
- Evdence of an IDH1 mutation presence by next generation sequencing panel at original diagnosis.
- Evidence of engraftment by Absolute neutrophil count (ANC) \>/= 1.0x 109/L without daily use of myeloid growth factor (G-CSF) for at least 7 days...
- Patient in morphologic remission with Day +30 bone marrow \<5% blast. Will include MRD positive or negative.
- Age 18 to 75 years old.
You likely can't join if
- Use of any of the following after transplantation and prior to starting study therapy. Anti-leukemic agents given as post-transplant maintenance...
- Overall grade II-IV aGVHD. However, upon complete resolution of aGVHD-related symptoms with grade 1 or 0 overall clinical grade would be appropriate...
- cGVHD, moderate or servere by NIH criteria.
- Active uncontrolled systemic fungal, bacterial, or viral infection. However, patients receiving anti-micobial agents including antibiotics, antiviral...
- Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
- Patients with known active hepatitis B virus (HBV) infection will be excluded because of potential effects on immune function and/or drug...
See the full eligibility criteria
- Diagnosis of AML, MDS, MPN, or CMML according to World Health Organization (WHO) classification that underwent first or second alloSCT regardless of stem cell source, donor type/match, conditioning regimen, or GVHD...
- Evdence of an IDH1 mutation presence by next generation sequencing panel at original diagnosis.
- Evidence of engraftment by Absolute neutrophil count (ANC) \>/= 1.0x 109/L without daily use of myeloid growth factor (G-CSF) for at least 7 days; and Platelet \>/= 30 x 109/L with out platelet transfusion within 1 week.
- Patient in morphologic remission with Day +30 bone marrow \<5% blast. Will include MRD positive or negative.
- Age 18 to 75 years old.
- ECOG performance status of 0, 1, 2. Or KPS above 70.
- Creatinine clearance greater or equal to 40cc/min as defined by the Cockcroft-Gault Equation. Males (mL/min): (140-age) \ IBW (kg) / 72\ (serum creatinine(mg/dl)) Females (mL/min): 0.85\ (140-age) \ IBW (kg) / 72\...
- Serum bilirubin \</= 1.5 x upper limit of normal (ULN) except in people with Gilbert's Syndrome in whom total bilirubin must be \</= 3.0 mg/dl. Aspartate transaminase (AST) or alanine transaminase (ALT) \</= 2.5 x ULN...
- No active bleeding.
- No clinical evidence of life-threatening infection.
- Capable of understanding the investigational nature, potential risks, and benefits of the study, and able to provide valid informed consent.
- Negative serum or urine pregancy test for wome with reproductive potential at screening.
- Female participants of non-childbearing potential must meet at least one of the following criteria:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomey.
- Ovarian failure (follicle-stimulating hormone and Estradiolin menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure
- people who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months...
- Use of any of the following after transplantation and prior to starting study therapy. Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous, or oral 5-azacitidine or FL T3 inhibitors for...
- Overall grade II-IV aGVHD. However, upon complete resolution of aGVHD-related symptoms with grade 1 or 0 overall clinical grade would be appropriate to enroll at that time. Patients may be eligible for enrollment if...
- cGVHD, moderate or servere by NIH criteria.
- Active uncontrolled systemic fungal, bacterial, or viral infection. However, patients receiving anti-micobial agents including antibiotics, antiviral and antifungal therapies are allowed if the infection is controlled...
- Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
- Patients with known active hepatitis B virus (HBV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient has HBV history with an undetectable HBV load...
- Patients with known active hepatitis C virus (HCV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient with a history of HCV infection has received...
- Patients with known active HIV infection will be excluded out of concern for the drug-drug interaction with venetoclax and highly active antiretroviral therapy (HART)
- QT prolongation of corrected QTcF interval (QTc) \> 480 milliseconds
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- Patients with cognitive impairments or psychiatric disorders that can interfere with safety or with obtaining informed consent of compliance with study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.