Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well tagraxofusp works with two chemotherapy drugs, cladribine and cytarabine. It is for adults with acute myeloid leukemia (AML), a blood cancer, that has come back or did not respond to treatment. Their cancer must test positive for CD123.
To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with AML that has come back or resisted treatment, and a positive CD123 test.
- Have first received venetoclax with azacitidine or decitabine. No later treatment is allowed except an IDH or FLT3 blocker for people with those gene changes.
- Be able to care for yourself and be up and about for more than half of your waking hours.
- Have albumin, a blood protein, of at least 3.2 g/dL without taking albumin to meet this limit.
- Have a heart pumping level of at least 50% and no major problems on an ECG, a test of the heart's electrical activity.
- Meet the study's liver and kidney test limits.
- If able to become pregnant, have a negative pregnancy test and use highly effective birth control or avoid sex with men before treatment, during treatment, and for 30 days afterward. Men able to father a child must use condoms.
- Understand and sign the consent form, agree to study procedures, and be available for the full study.
Who can't join
- Have received cancer treatment other than the treatments allowed above, or cancer drugs that act throughout the body within 14 days before study treatment. Hydroxyurea is allowed only during the first cycle if needed to control AML.
- Have serious heart disease, uncontrolled high blood pressure or heart rhythm problems, or a recent stroke; or have uncontrolled serious lung disease.
- Have an uncontrolled infection, known HIV, or active hepatitis B or C.
- Have lasting, significant side effects from earlier treatment that supportive care cannot easily control. Hair loss, nausea, and tiredness do not count.
- Have another cancer that could affect the study results. Some cancers are allowed; some recent cancer histories need study team review.
- Have known or suspected active disease in the brain or spinal cord. Suspected disease must be ruled out with tests.
- Take medicine that weakens the immune system, except prednisone at 10 mg a day or less, or have had a stem cell transplant from a donor.
- Be pregnant or breastfeeding, or have an uncontrolled illness, mental health condition, or social situation that would prevent following study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria * Documented diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to World Health Organization (WHO) 2022 criteria * Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity * Must have received initial therapy with venetoclax in combination with a hypomethylating agent (either azacitidine or decitabine) with no subsequent therapy unless mutations in the IDH or FLT3 genes. If mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required. * Age ≥ 18 years of age * ECOG ≤ 2 * Albumin ≥ 3.2 g/dL at time of screening (note that albumin supplementation is not permitted to enable eligibility) * Left ventricular ejection fraction ≥ 50% * No clinically significant abnormalities on 12-lead electrocardiogram (ECG) including: complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \>250ms, or QTcF (Friderica's method) \>450ms in 3 successive measurements * Stated willingness to comply with all study procedures and availability for the duration of the study * Females of reproductive potential need to either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with highly effective contraception without interruption prior to starting treatment, during the study therapy, and for 30 days after last dose of study therapy * For males of reproductive potential: agreement to use of condoms * Adequate hepatic/renal function defined as: Hepatic function: total bilirubin ≤ 1.5 x ULN (unless attributable to Gilbert's disease or leukemic involvement) AND AST or ALT ≤ 3 x ULN Renal function: creatinine clearance \> 30 mL/minute, calculated by Cockcroft Gault formula * Women of childbearing potential must have a negative urine or serum pregnancy test * Ability to understand and the willingness to provide written informed consent. Exclusion Criteria: * Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors * Patients who received systemic anti-cancer therapy \<14 days prior to their first day of study drug administration. * Patients who received systemic anti-cancer therapy \<14 days prior to their first day of study drug administration. Concurrent hydroxyurea will be allowed. Hydroxyurea use will be allowed only during the first cycle if needed for disease control. * Significant cardiac disease (any NYHA Class 3 or 4 CHF, uncontrolled angina, history of MI, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication) * Any uncontrolled bacterial, fungal, viral or other infection. * Known HIV+ or active hepatitis B or C infection, defined as positive viral load for HBV or HCV or a positive surface antigen (HBsAg) test for hepatitis B. * The patient has persistent clinically significant toxicities Grade \>/= 2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue). * The patient has an active malignancy and/or cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of study entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with study team before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease. * The patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study. * The patient has known active or suspected CNS disease. If suspected, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid. * The patient is receiving immunosuppressive therapy - with the exception of low-dose prednisone (\</= 10 mg/day). * Received allogenic stem cell transplant prior to the treatment. * The patient has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast feeding
Study sites (1)
CA
- Stanford University · Palo Alto, CA 94304Woo In (Yustina) Cho · Study contact · 650-721-2443 · wooin@stanford.eduGabriel Mannis · Principal investigatorMore trials in Palo Alto