Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia
- Conditions
- Lymphoid LeukemiaAcute Lymphoblastic LeukemiaRefractory Acute Lymphoblastic LeukemiaRelapsed Acute Lymphoblastic Leukemia
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria:<br><br> - Willing and able to provide written informed consent/assent for the trial.<br><br> - Be = 18 years of age on day of signing informed consent.<br><br> - Able to adhere to the study visit schedule and other protocol requirements.<br><br> - Pathologically confirmed B- or T-cell acute lymphoblastic or mixed phenotype acute<br> leukemia, with >5% peripheral blood or bone marrow lymphoblasts and/or<br> extramedullary disease >1x1cm.<br><br> - Relapsed or refractory acute lymphoblastic leukemia after at least 1 prior cycle of<br> therapy. Patients with Philadelphia chromosome positive disease must have failed at<br> least two prior tyrosine kinase inhibitors.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0-1.<br><br> - Cardiac ejection fraction = 50% by echocardiography or multigated acquisition scan<br> (MUGA).<br><br> - Must be at least 2 weeks out from any prior systemic chemotherapy, blinatumumab,<br> radiation, and/or other investigational agents, and have recovered to grade 1 from<br> any toxicity related to prior therapy. Glucocorticoids are permitted up to 1 day<br> prior to the first dose.<br><br> - Serum bilirubin and creatinine less than 1.5x upper limit of normal (ULN). AST and<br> ALT must be less than 3x ULN, unless there is suspected liver involvement.<br><br> - Females of childbearing potential (FCBP) must have a negative serum pregnancy test<br> at screening. A FCBP is considered when a sexually mature female: 1) has not<br> undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally<br> postmenopausal for at least 12 consecutive months.<br><br> - A FCBP must agree to use of two methods of highly effective contraception, be<br> surgically sterile, or abstain from heterosexual activity for the course of the<br> study through 30 days after the last dose of study treatment.<br><br> - Male participants must agree to use an adequate method of contraception starting<br> with the first dose of study therapy through 30 days after the last dose of study<br> therapy. Men must agree to not donate sperm during and after the study<br><br>Exclusion Criteria:<br><br> - Clinical evidence of active central nervous system (CNS) leukemia.<br><br> - Any major surgery or radiation therapy within four weeks.<br><br> - Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or<br> Hepatitis C.<br><br> - Has a history or current evidence of any condition, therapy, or laboratory<br> abnormality that might confound the results of the trial, interfere with the<br> subject's participation for the full duration of the trial, or is not in the best<br> interest of the subject to participate, in the opinion of the treating investigator<br> (including but not limited to severe graft-versus-host disease, unstable angina,<br> pulmonary hypertension, active/prior veno-occlusive disease of the liver or severe<br> CHF (NYHA III-IV).<br><br> - Patients with active (uncontrolled, metastatic) second malignancies.<br><br> - Is pregnant or breastfeeding, or expecting to conceive or father children within the<br> projected duration of the trial, starting with the screening visit through 30 after<br> the last dose of trial treatment.<br><br> - Hypersensitivity to cytarabine, daunorubicin, or liposomal products.<br><br> - History of Wilson's disease or other copper-metabolism disorder.<br><br> - Patients with prior cumulative anthracycline exposure of greater than 368 mg/m^2<br> daunorubicin or equivalent).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Remission Rate (CR) + CR With Incomplete Recovery (CRi)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS);Overall Survival (OS);Minimal Residual Disease (MRD)