Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients with Down Syndrome
Description
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.
Eligibility Criteria
Inclusion Criteria
- Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])
- Patient has one of the following: * Patients has previously untreated de novo AML and meets the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification ** Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis * Patients has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS) * Patients has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who: * Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR * Patients who have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart
- Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
- There are no minimal organ function requirements for enrollment on this study * Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
- Each patient’s parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met
Exclusion Criteria
- Patients with promyelocytic leukemia (French-American-British [FAB] M3)
- Prior therapy * Patients =< 30 days from the last dose of cytarabine used for treatment of TMD
Locations & Contacts
Alabama
Birmingham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Alaska
Anchorage
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Arizona
Mesa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Phoenix
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 602-546-0920
Arkansas
Little Rock
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
California
Downey
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 510-891-3400
Loma Linda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 310-423-8965
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Madera
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Palo Alto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Sacramento
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-454-6500
Email: cancerinfo@sutterhealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 619-532-8712
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
San Francisco
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-3222
Torrance
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 310-222-3621
Colorado
Aurora
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Denver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Connecticut
Hartford
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New Haven
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Delaware
Wilmington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-651-6884
Email: dperry@nemours.org
District of Columbia
Washington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Florida
Fort Myers
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Gainesville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Hollywood
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Miami
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 321-843-2584
Email: melissa.leffin@orlandohealth.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
West Palm Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Georgia
Atlanta
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Hawaii
Honolulu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 808-983-6090
Idaho
Boise
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Illinois
Chicago
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-355-3046
Oak Lawn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Park Ridge
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Peoria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-545-7929
Indiana
Indianapolis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-248-1199
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
Iowa
Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Iowa City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-237-1225
Kentucky
Lexington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Louisiana
New Orleans
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org
Maine
Bangor
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 207-973-4274
Maryland
Baltimore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-601-6120
Email: pridgely@lifebridgehealth.org
Bethesda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 301-319-2100
Massachusetts
Boston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-442-3324
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 617-636-5535
Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 413-794-3565
Email: tamara.wrenn@baystatehealth.org
Worcester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu
Michigan
Ann Arbor
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Detroit
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kalamazoo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-0360
Minnesota
Minneapolis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-776-0015
Mississippi
Jackson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 601-815-6700
Missouri
Columbia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kansas City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saint Louis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-251-6770
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Nevada
Las Vegas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
New Hampshire
Lebanon
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu
New Jersey
Hackensack
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 732-235-8675
Paterson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New York
Albany
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 518-262-5513
Buffalo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Mineola
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-946-8476
New York
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 914-594-3794
North Carolina
Asheville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
Chapel Hill
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-9376
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-384-5369
Email: nnechiporchik@novanthealth.org
Durham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-275-3853
Greenville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 252-744-1015
Email: eubankss@ecu.edu
Winston-Salem
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771
North Dakota
Fargo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-437-4010
Ohio
Akron
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Cincinnati
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Cleveland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dayton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Toledo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842
Oklahoma
Oklahoma City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Oregon
Portland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu
Pennsylvania
Danville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hershey
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Philadelphia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Puerto Rico
San Juan
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Rhode Island
Providence
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 401-444-1488
South Carolina
Charleston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
South Dakota
Sioux Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org
Tennessee
Chattanooga
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Knoxville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Nashville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-811-8480
Texas
Austin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Dallas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 972-566-5588
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Fort Worth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Houston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
Lubbock
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
San Antonio
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu
Utah
Salt Lake City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Vermont
Burlington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-656-8990
Virginia
Falls Church
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Norfolk
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Richmond
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: mwellons@vcu.edu
Washington
Seattle
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Spokane
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Tacoma
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-968-0129
Email: mamcdci@amedd.army.mil
West Virginia
Charleston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-388-9944
Wisconsin
Madison
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 414-955-4727
Email: MACCCTO@mcw.edu
British Columbia
Vancouver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Manitoba
Winnipeg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-561-1026
Email: ctu_web@cancercare.mb.ca
Nova Scotia
Halifax
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 902-470-6767
Ontario
Hamilton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kingston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 613-549-6666
Email: cc-clinicaltrials@kgh.kari.net
London
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Ottawa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Toronto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca
Quebec
Montreal
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-345-4931
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Quebec
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Australia
Hunter Regional Mail Centre
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Parkville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Perth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Randwick
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Westmead
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
New Zealand
Christchurch
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 03 364 0640
Grafton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Saudi Arabia
Riyadh
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 011-966-1-464-7272 ext 38005
Trial Objectives and Outline
PRIMARY OBJECTIVES:
I. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.
II. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.
EXPLORATORY OBJECTIVES:
I. To determine the extent to which elimination of HD Ara-C from the treatment of standard risk DS AML decreases adverse events and resource utilization.
II. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number of days per patient spent on protocol therapy compared to predecessor study AAML0431.
III. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the average number of days of hospitalization per patient compared to predecessor studies AAML0431 and A2971.
IV. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number (per patient) and rate (per duration of treatment) of sterile site infections compared to the predecessor study AAML0431.
V. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease of resource utilization by AML treatment compared to the predecessor study AAML0431.
VI. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.
VII. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.
OUTLINE:
INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.
Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.
ARM A (STANDARD RISK):
INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.
INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.
INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.
INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.
ARM B (HIGH RISK):
INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours every 12 (Q12) hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.
INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 90-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.
INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.
After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 10 years, and then at relapse.
Trial Phase & Type
Treatment
Lead Organization
Lead Organization
Childrens Oncology Group
Principal Investigator
Jason Noah Berman