Azacitidine and Combination Chemotherapy in Treating Infants with Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

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Status: Active

Description

This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Infants must be > 36 weeks gestational age at the time of enrollment
  • Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic
  • Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment

Exclusion Criteria

  • Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
  • Patients with Down syndrome
  • Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
  • With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org
Mobile
University of South Alabama
Status: Active
Contact: Felicia Little Wilson
Phone: 251-665-8000

Alaska

Anchorage
Providence Alaska Medical Center
Status: Active
Contact: Brenda J. Wittman
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Erlyn C. Smith Email: helpdesk@childrensoncologygroup.org
Phoenix
Phoenix Childrens Hospital
Status: Active
Contact: Jessica Boklan
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: David L. Becton
Phone: 501-686-8274

California

Downey
Southern California Permanente Medical Group
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Albert Kheradpour
Phone: 909-558-3375
Los Angeles
Children's Hospital Los Angeles
Status: Active
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Madera
Children's Hospital Central California
Status: Active
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Carla Barbara Golden Email: helpdesk@childrensoncologygroup.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Sheri L Spunt Email: helpdesk@childrensoncologygroup.org
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Mignon Lee-Cheun Loh
Phone: 877-827-3222
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Eduard H. Panosyan
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Kelly Wilson Maloney Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Jennifer Jocelyn Clark Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Michael Scott Isakoff
Phone: 800-579-7822
New Haven
Yale University
Status: Active
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Emad K. Salman Email: helpdesk@childrensoncologygroup.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: William Birdsall Slayton Email: helpdesk@childrensoncologygroup.org
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Iftikhar Hanif Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Florida Hospital Orlando
Status: Active
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Pensacola
Nemours Children's Clinic - Pensacola
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Jennifer Lynne Root Mayer Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Mark J. Mogul
Phone: 704-384-5369
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Melinda Gordon Pauly Email: helpdesk@childrensoncologygroup.org
Savannah
Memorial Health University Medical Center
Status: Active
Contact: J. Martin Johnston
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Wade T. Kyono
Phone: 808-586-2979

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Eugenia Chang Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Nobuko Hijiya Email: helpdesk@childrensoncologygroup.org
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Jennifer Lynn McNeer
Phone: 773-834-7424
University of Illinois
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Eugene Suh
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Rebecca Erin McFall Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Caroline Yingwen Hu
Phone: 847-384-3621
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Pedro A. De Alarcon
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford Email: helpdesk@childrensoncologygroup.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Active
Contact: Ashok B. Raj
Phone: 502-562-3429

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Active
Contact: Lolie C. Yu Email: helpdesk@childrensoncologygroup.org
Ochsner Medical Center Jefferson
Status: Active
Contact: Craig Lotterman
Phone: 504-842-3708

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Nadine Patricia Sauer SantaCruz
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Eric C. Larsen
Phone: 207-396-8090 Email: wrighd@mmc.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Patrick A. Brown
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Active
Contact: Jason M. Fixler
Phone: 410-601-6120 Email: pridgely@lifebridgehealth.org

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Lewis Barry Silverman
Phone: 877-442-3324
Floating Hospital for Children at Tufts Medical Center
Status: Active
Contact: Michael J. Kelly
Phone: 617-636-5535
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Christopher P. Keuker
Phone: 508-856-3216 Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Rajen Mody Email: helpdesk@childrensoncologygroup.org
Detroit
Saint John Hospital and Medical Center
Status: Active
Contact: Adonis N. Lorenzana
Phone: 313-343-3166
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Renuka Gera
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Active
Contact: Laura Kate Gowans
Phone: 248-551-0360

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Vilmarie Rodriguez
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Anderson (Andy) Burton Collier
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Barbara Anne Gruner Email: helpdesk@childrensoncologygroup.org
Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Keith Jason August Email: helpdesk@childrensoncologygroup.org
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Active
Contact: William Shay Ferguson Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Active
Contact: Bethany Graham Sleckman
Phone: 314-251-6770
Washington University School of Medicine
Status: Active
Contact: Shalini Shenoy
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Minnie Abromowitch Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Minnie Abromowitch
Phone: 402-559-6941 Email: unmcrsa@unmc.edu

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Burton Eliot Appel
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Steven Lon Halpern
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Active
Contact: Nibal Ahmad Zaghloul Email: helpdesk@childrensoncologygroup.org
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Peri Kamalakar
Phone: 973-926-7230

New York

Albany
Albany Medical Center
Status: Active
Contact: Kenneth G. Lucas
Phone: 518-262-3368
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Clare J. Twist
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Arlene Sara Redner Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Alice Lee
Phone: 212-305-8615
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Sharon Leigh Gardner
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Mount Sinai Hospital
Status: Active
Contact: Birte Wistinghausen
Phone: 212-824-7309 Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Laura Elaina Hogan
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Philip M. Monteleone
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Active
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Joel A. Kaplan
Phone: 704-355-2884
Greenville
East Carolina University
Status: Active
Contact: Andrea Ruth Whitfield
Phone: 252-744-2391
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Maureen Megan O'Brien Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Aron Flagg
Phone: 866-223-8100
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Janice Faye Olson
Phone: 503-413-8199

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Lydia Alberta Boateng
Phone: 734-712-3671
Danville
Geisinger Medical Center
Status: Active
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: Active
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Susan Robbins Rheingold Email: helpdesk@childrensoncologygroup.org
Childrens Oncology Group
Status: Active
Contact: Erin Marie Guest
Phone: 816-234-3265
Saint Christopher's Hospital for Children
Status: Active
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Arthur Kim Ritchey Email: helpdesk@childrensoncologygroup.org

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: Active
Contact: Jhon Alfredo Guerra
Phone: 787-653-3434
San Juan
San Jorge Children's Hospital
Status: Active
Contact: Luis A. Clavell Email: helpdesk@childrensoncologygroup.org

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Jennifer J. Greene Welch
Phone: 401-444-1488

South Carolina

Columbia
Palmetto Health Richland
Status: Active
Contact: Stuart Louis Cramer
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Active
Contact: Manoo G. Bhakta Email: helpdesk@childrensoncologygroup.org
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Ray C. Pais
Phone: 865-541-8266
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Haydar A. Frangoul
Phone: 800-811-8480
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Debra L. Friedman
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Tamra Lynn Slone
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Active
Contact: Lisa Louise Rubin Hartman Email: helpdesk@childrensoncologygroup.org
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Kenneth Matthew Heym Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: ZoAnn Eckert Dreyer
Phone: 713-798-1354 Email: burton@bcm.edu
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Kishor Mallikarjun Bhende
Phone: 806-775-8590
University Medical Center
Status: Active
Contact: Mohamad M. Al-Rahawan
Phone: 309-655-3258
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Timothy C. Griffin
Phone: 800-248-1199
Methodist Children's Hospital of South Texas
Status: Active
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Vermont

Burlington
University of Vermont College of Medicine
Status: Active
Contact: Alan Charles Homans
Phone: 802-656-8990

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: William Carl Petersen
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Active
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Mandy M Atkinson Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org

West Virginia

Charleston
West Virginia University Charleston
Status: Active
Contact: Ashley E. Meyer
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Marshfield
Marshfield Clinic
Status: Active
Contact: Michael John McManus
Phone: 715-389-4457
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Michael James Burke
Phone: 414-955-4727 Email: MACCCTO@mcw.edu

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Kingston
Kingston Health Sciences Centre
Status: Active
Contact: Mariana Pradier Silva
Phone: 613-549-6666 Email: cc-clinicaltrials@kgh.kari.net
London
Children's Hospital
Status: Active
Contact: Shayna M. Zelcer Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Donna Lynn Johnston Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Active
Contact: Sumit Gupta
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
The Montreal Children's Hospital of the MUHC
Status: Active
Contact: Sharon Barbara Abish Email: helpdesk@childrensoncologygroup.org

Australia

Perth
Princess Margaret Hospital for Children
Status: Active
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate the tolerability of azacitidine in addition to Interfant-06 standard chemotherapy in infants with newly diagnosed acute lymphoblastic leukemia (ALL) with KMT2A gene rearrangement (KMT2A-R).

SECONDARY OBJECTIVES:

I. To evaluate the biologic activity of azacitidine by pharmacodynamic assessment of global deoxyribonucleic acid (DNA) methylation in peripheral blood mononuclear cells (PBMCs) of infants treated with azacitidine.

TERTIARY OBJECTIVES:

I. To determine the 5 year event-free survival (EFS) of infants with KMT2A-R treated with azacitidine in addition to Interfant-06 standard chemotherapy.

II. To correlate minimal residual disease (MRD) with outcome in the context of the protocol therapy.

III. To perform pharmacokinetic (PK) testing of azacitidine in infants.

IV. To test the expansion of infant T lymphocytes by stimulation with artificial antigen presenting cells identical to those used in chimeric antigen receptor T-cell (CART)-19 production.

V. To collect pharmacodynamic (PD) data for asparaginase activity following pegaspargase administration in infants.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity. Only patients with KMT2A-R continue to post-induction chemotherapy.

POST-INDUCTION CHEMOTHERAPY:

AZACITIDINE BLOCK I: Prior to CONSOLIDATION, patients receive azacitidine IV over 10-40 minutes daily for 5 days in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Following completion of AZACITIDINE BLOCK I, patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, mercaptopurine PO or NG daily on days 1-28, cytarabine IV or subcutaneously (SC) daily on days 3-6, 10-13, 17-20, and 24-27 and IT on day 10, methotrexate IT on day 24, and hydrocortisone sodium succinate IT on days 10 and 24 in the absence of disease progression or unacceptable toxicity.

AZACITIDINE BLOCK II: Prior to INTERIM MAINTENANCE, patients receive azacitidine as in AZACITIDINE BLOCK I

INTERIM MAINTENANCE: Following completion of AZACITIDINE BLOCK II, patients receive mercaptopurine PO or NG daily on days 1-14, methotrexate IV over 24 hours on days 1 and 8 and IT on days 2 and 9, leucovorin calcium PO or IV on days 3-4 and 10-11, hydrocortisone sodium succinate IT on days 2 and 9, cytarabine IV over 3 hours every 12 hours on days 15-16 and 22-23 for a total of 8 doses, and pegaspargase IV over 1-2 hours or IM on day 23 in the absence of disease progression or unacceptable toxicity.

AZACITIDINE BLOCK III: Prior to DELAYED INTENSIFICATION PART I, patients receive azacitidine as in AZACITIDINE BLOCK I.

DELAYED INTENSIFICATION PART I: Following completion of AZACITIDINE BLOCK III, patients receive pegaspargase IV over 1-2 hours or IM on day 1, dexamethasone PO, NG, or IV TID on days 1-14 and 15-21 with a taper on days 15-21, thioguanine PO or NG daily on days 1-28, vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine IV or SC on days 2-5, 9-12, 16-19, and 23-26 and IT on days 1 and 15, and hydrocortisone sodium succinate IT on days 1 and 15 in the absence of disease progression or unacceptable toxicity.

AZACITIDINE BLOCK IV: Prior to DELAYED INTENSIFICATION PART II, patients receive azacitidine as in AZACITIDINE BLOCK I.

DELAYED INTENSIFICATION PART II: Following completion of AZACITIDINE BLOCK IV, patients receive thioguanine PO or NG daily on days 1-14, cyclophosphamide IV over 15-30 minutes on days 1 and 15, cytarabine IV or SC on days 2-5 and 9-12 in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Following DELAYED INTENSIFICATION PART II, patients receive mercaptopurine PO or NG on days 1-168, methotrexate IT on day 1 and 92 and PO once weekly on days 8-91 and 98-168, hydrocortisone sodium succinate IT on day 1, 57, and 99, and cytarabine IT on day 57. Starting on day 169, patients receive mercaptopurine PO or NG on days 1-84 and methotrexate PO once weekly. Courses repeat every 84 days for 2 years from the start of INDUCTION CHEMOTHERAPY in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Erin Marie Guest

Trial IDs

Primary ID AALL15P1
Secondary IDs NCI-2016-00973, s17-00488
Clinicaltrials.gov ID NCT02828358