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A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)
This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
There are different phases of this study. The first phase is Screening, then there is the Treatment phase as well as a Follow up phase. Each phase will have testing and procedures that will require you to come to the study center.
50.00 Travel expenses
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.
If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.
POE23-01 - TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II
This study is being done to improve upon the previous TINI study treatment. It replaces one of the chemotherapy cycles with a type of immunotherapy called blinatumomab. The use of blinatumomab in this study is investigational. In addition, infants that have persistent disease will receive a new investigational drug called ziftomenib that specifically targets infant ALL cells.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, lumbar puncture, and chest x-ray.Treatment on this study from Day 1 of Remission Induction period through the end of Maintenance period will last almost 2 years. After study treatment is completed, you will have blood tests and other evaluations. You will be seen every 4 months for the first year, every 6 months for the second year, and then once a year for up to 10 years.
Newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia.
Limited prior therapy
Patients with mature B-cell ALL that does not have a KMT2Ar or patients with acute myelogenous (AML) or T-cell ALL
Patients with Down syndrome
A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)
This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.
venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.
Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years.After you finish your study treatment, doctor will continue to follow condition for 10 years.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
PSCI 24-106 B: A Measurable Residual Disease (MRD) Focused, Phase II Study Of Venetoclax Plus Chemotherapy For Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 Myelomatch Clinical Trial
Participants take part in this research study because they have a new diagnosis of acute myeloid leukemia (AML). Study is looking at to see if treatment can be improved by adding venetoclax to the usual chemotherapy: cytarabine and daunorubicin (also known as 7+3), or azacitidine? This study wants to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for AML.
Participants will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. Subjects treatment may be extended by a few weeks if subject needs additional therapy. Doctor will continue to follow your condition for 5 years and watch subject for side effects and keep track of their health. After study treatment, subjects may also be offered another clinical trial through the myeloMATCH study. Subjects will be followed on this study even if they continue onto another study. Follow-up includes a clinic visit 28 days after subjects treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after treatment is completed.
Participants must have been registered to Master Screening and Re-Assessment Protocol
Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow
ECOG performance status ≤ 3.
WBC must be <25x109/L.
Patients who are receiving any other investigational agents.
Pregnant women are excluded
Patients with isolated myeloid sarcoma are not eligible
active, uncontrolled bacterial, fungal, or viral infection
PSCI 24-106: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial
This study is being done to answer the following question: Can we shrink the amount of AML or get rid of it in your bone marrow and body by treating you with the standard approach of cytarabine + daunorubicin (7+3) or one of the following experimental groups: 1) cytarabine and daunorubicin with venetoclax 2) azacitidine and venetoclax, 3) daunorubicin and cytarabine liposome, or 4) daunorubicin and cytarabine liposome with venetoclax?Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants must have high-risk (adverse) AML per ELN 2017 criteria.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants with favorable or intermediate risk disease are excluded.
Participants with FLT3 mutations (ITD or TKD) are excluded.
Participants with t(9;22) translocation are excluded.