Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Rare Diseases

Neoplasm Metastasis

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Anti-Inflammatory Agents

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Methotrexate

Daunorubicin

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

Participants will receive CPX-351 for remission induction, and then will proceed to allogeneic HSCT or other therapies as per institutional practice.

Intrathecal (IT) chemotherapy will be given on Day 1 of each cycle, for all participants, but may be delayed if clinically indicated. IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) according to age are all acceptable.

CPX-351

Allogeneic Hematopoietic Stem Cell Transplantation

Raul C. Ribeiro, MD

Marcin Wlodarski, MD, PhD

The purpose of this study is to learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).

Primary Objective

* Determine the composite complete remission (CR) and complete remission with incomplete peripheral blood recovery (CRi) rates, safety and tolerability in patients under 22 years of age with SMN treated with one or two courses of CPX-351 before HSCT.

Secondary Objectives

* Describe the toxicity profile of patients with SMN treated with one or two courses of CPX-351.
* Describe the biologic correlates of response in patients with SMN after one or two courses of CPX-351.
* Estimate the 3-year overall survival of patients who received one or two courses of CPX-351 followed by HSCT.

Participants who meet the inclusion criteria and consent will receive up to 2 cycles of CPX-351 for remission induction, and then will proceed to allogeneic HSCT or other therapies as per institutional practice. If a patient attains remission and has negative MRD after the first course of CPX-351, and HSCT can occur within 4 weeks from the evaluation date of the first course, the patient can proceed to HSCT without receiving the second course of CPX-351.

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

A Prospective, Multicenter, Single-Arm Pilot Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

The Simon's two-stage minimax design with be used. Complete morphologic remission response (CR) is defined as less than 5% blasts without Auer rods by morphological evaluation of the bone marrow (M1 marrow).

The Simon's two-stage minimax design with be used. Complete remission with incomplete peripheral blood recovery (CRi) is defined as hematologic recovery hematological (white cell blood count ≥ 1.0 x 109/L, unsupported platelet count ≥ 30.0 x 109/L and absolute neutrophil count ≥ 0.3 x 109/L).

The exact three-stage binomial design will be used to monitor tolerability. We define a tolerability success as a patient completing two courses of therapy without experiencing a grade 4 or 5 non-hematologic toxicity.

We will define categories for toxicity events and for each category we will determine the highest grade experienced by each patient. We will then report the number of patients with each grade in each category.

We will use logistic regression modeling explore biologic correlates as predictors of response. For genomic associations, we will use false discovery rate methods to address multiple testing.

We will use the Kaplan-Meier method to estimate overall survival. We define OS as the time elapsed from protocol enrollment to death and censor times of living patients at last follow-up.

We will use the Kaplan-Meier method to estimate event-free survival. We define EFS as the time elapsed from protocol enrollment to death, relapse, discontinuation of therapy due to excessive toxicity or resistant disease, or development of an additional malignancy and censor times for patients free of these events at last follow-up.

To explore the impact of transplant, we will fit Cox models with transplant as a time-dependent covariate.

Jazz Pharmaceuticals

St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for mha

Every month we try and update this database with for mha cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mha

Every month we try and update this database with for mha cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mha cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.