SWOG clinical trial number

S0106

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotargï¿½) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotargï¿½) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

93% Accrual

Accrual

93%

Closed

Phase

93% Accrual

Accrual

93%

Published

Abbreviated Title

Phase III Starndard + Mylotarg vs. Standard + Daunomycin/Ara-C for AML Under Age 61

Activated

05/15/2004

Closed

08/20/2009

Participants

NCORP, Members, Medical Oncologists, Pathologists, CTSU

Research committees

Leukemia

Treatment

Cytosine Arabinoside Daunomycin Gemtuzumab Ozogamicin rhGM-CSF G-CSF

Eligibility Criteria Expand/Collapse

Pts must have a morphologically confirmed diagnosis of AML with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration. Pts with M3 AML or blastic transformation of CML are not eligible. Pts with preexisting hematologic disorder evolving to AML such as myelodysplasia or secondary leukemia are not eligible. Pts must have reached their 18th birthday but not reached their 61st birthday. Zubrod PS of 0-3. Pt must have a bilirubin less than or equal to 2 x IULN. Pt must also have SGOT (AST) less than or equal to 3 x IULN and SGPT (ALT) less than or equal to 3 x IULN. Studies must be performed within 14 days prior to registration. Pts must have a normal left ventricular function with an ejection fraction less than or equal to 50% as measured by MUGA scan or 2-D ECHO within 42 days prior to registration. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not have received systemic chemotherapy or more than one dose of intrathecal chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted. Pretreatment pathology materials must be submitted for morphologic review as per the protocol. Pts must participate in cytogenetics studies as detailed in Section 5.1h. Collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. SWOG pts (and other pts not affiliated with CALGB or NCIC) must be registered on protocol S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary." Collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. CALGB pts are encouraged to register to C9665. NCIC pts are encouraged to register to S9910. Specimens collected within 14 days prior to reg must be submitted for studies of FLT3 and flow cytometric MRD detection. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 yrs. Pts who have known liver disease or known Hepatitis B(HbsAg positive) or active Hepatitis C infection are not eligible. If viral status is not known, pts are eligible for study.

Publication Information Expand/Collapse

Other Clinical Trials

CTSU/A042001

SWOG Clinical Trial Number

A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia

Research Committee(s)

Leukemia

Activated

02/27/2023

Open

Phase

S1925

SWOG Clinical Trial Number

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.

Research Committee(s)

Leukemia

Lymphoma

Symptom Control and Quality of Life

Activated

12/14/2020

62% Accrual

Accrual

62%

Open

Phase

CTSU/AALL1821

SWOG Clinical Trial Number

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination with Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old with First Relapse

Research Committee(s)

Leukemia

Activated

12/04/2020

Open

Research committees

Treatment

Eligibility Criteria Expand/Collapse

Publication Information Expand/Collapse

2024

2023

2022

2021

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

Other Clinical Trials

A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination with Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old with First Relapse