Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	1 to under 30	NCI	COG-AALL0433 AALL0433, NCT00381680

Objectives

Primary

1. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia.

Secondary

1. Compare the 3-year event-free survival and frequency and severity of adverse effects in patients treated with high-dose vs low-dose vincristine.
2. Compare, descriptively, the outcomes of patients treated with combination chemotherapy vs those treated with matched sibling-related donor hematopoietic stem cell transplantation (for those with eligible donors).

Entry Criteria

Disease Characteristics:

• Diagnosis of acute lymphoblastic leukemia (ALL)
  • Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)
    • Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)



• Intermediate-risk relapsed disease, meeting 1 of the following criteria:
  • Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
  • Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36 months after initial diagnosis
  • Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after initial diagnosis

   [Note: *CNS relapse is defined as WBC ≥ 5/mm³ in cerebral spinal fluid (CSF) with blasts present on cytospin OR any number of WBC in CSF with immunophenotypic proof of leukemic relapse (defined as identifiable blasts plus [for B-lineage] TdT or CD-10 positivity on 2 consecutive CSF samples obtained 4 weeks apart)]

   [Note: **Testicular relapse is defined as unilateral or bilateral testiculomegaly with biopsy-proven testicular involvement OR unilateral or bilateral testiculomegaly with concurrent relapse in the bone marrow and/or CNS ]




• The following subtypes are not allowed:
  • T-lineage ALL
  • Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
  • Philadelphia-chromosome positive disease



• No Down syndrome (trisomy 21)

Prior/Concurrent Therapy:

• At least 5 days since prior intrathecal chemotherapy
• No prior hematopoietic stem cell or marrow transplantation
• No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)
• No concurrent stem cell transplant
• No concurrent alternative therapy
• No concurrent itraconazole in patients receiving vincristine
• No concurrent intensity-modulated radiotherapy

Patient Characteristics:

• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• Bilirubin < 3.0 mg/dL
• Not pregnant
• Fertile patients must use effective contraception
• No history of peripheral neuropathy ≥ grade 3 within the past month
• No toxicity (i.e. peripheral neuropathy) ≥ grade 3 attributable to vincristine within the past month

Expected Enrollment

A total of 418 patients will be accrued for this study.

Outcomes

Efficacy of therapy
Event-free survival at 3 years

Frequency and severity of adverse effects at 3 years

Outline

This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

• Induction therapy 1 (weeks 1-5):
  • Arm I: Patients receive low-dose vincristine IV on days 1, 8, 15, and 22; oral prednisone 3 times daily on days 1-28; doxorubicin hydrochloride IV over 15 minutes on day 1; pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22; cytarabine intrathecally (IT) on day 1; and methotrexate IT* on days 15 and 29.
  
  
  
  • Arm II : Patients receive high-dose vincristine IV on days 1, 8, 15, and 22 and prednisone, doxorubicin hydrochloride, pegaspargase, cytarabine, and methotrexate* as in arm I.
  
  
  

   [Note: *CNS-positive patients do not receive methotrexate IT. In both arms, CNS-positive patients receive intrathecal triple therapy (ITT) comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, 22, and 29. CNS-positive patients not achieving remission after induction therapy 1 receive one additional dose of ITT on day 36.]

  Patients in both arms then proceed to induction therapy 2**.

   [Note: **Patients who are CNS-positive at relapse receive induction therapy 3 BEFORE induction therapy 2.]




• Induction therapy 2 (weeks 6-10 or 7-11): Once blood counts recover, all patients receive etoposide phosphate IV over ≥ 1 hour and cyclophosphamide IV over 1 hour on days 1-5; high-dose methotrexate IV continuously over 24 hours on day 22; leucovorin calcium IV or orally beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; and methotrexate IT* on days 1 and 22. Patients also receive filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 6 and continuing until blood counts recover.

   [Note: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 22.]

  Patients with testicular-relapse with persistent testicular disease at the end of induction therapy 1 undergo testicular radiotherapy once daily, 5 days a week, for 12 days during induction therapy 2**.

   [Note: **Radiotherapy should be completed before beginning high-dose methotrexate (week 9) chemotherapy.]

  All patients then proceed to induction therapy 3.




• Induction therapy 3 (weeks 11-15 or 12-16): All patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9, and asparaginase IM on days 2 and 9. Patients also receive G-CSF IV or SC beginning on day 10 and continuing until blood counts recover.

  Patients with a suitable HLA-matched related donor are removed from study and proceed to stem cell transplantation. Patients without a suitable HLA-matched related donor proceed to intensification therapy 1 (as per their randomized arm in induction therapy 1).




• Intensification therapy 1 (weeks 16-27 or 17-28):
  • Arm I: Patients receive low-dose vincristine IV and high-dose methotrexate IV continuously over 24 hours on day 1; leucovorin calcium IV or orally beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; oral mercaptopurine once daily on days 2-6; etoposide phosphate IV over ≥ 1 hour and cyclophosphamide IV over 1 hour on day 8; and methotrexate IT* on day 15. Treatment repeats every 21 days for 4 courses (with the exception of IT methotrexate which repeats for only 3 courses).
  
  
  
  • Arm II: Patients receive high-dose vincristine IV on day 1 and high-dose methotrexate, leucovorin calcium, mercaptopurine, etoposide phosphate, cyclophosphamide, and methotrexate IT* as in arm I.
  
  
  

   [Note: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 15. ITT repeats every 3 weeks for 3 courses.]

  Patients in both arms then proceed to reinduction therapy (as per their randomized arm in induction therapy 1).




• Reinduction therapy (weeks 28-32 or 29-33):
  • Arm I: Patients receive low-dose vincristine IV and doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15, oral dexamethasone twice daily on days 1-7 and 15-21, pegaspargase IM on days 2 and 15, and methotrexate IT* on days 1 and 28.
  
  
  
  • Arm II: Patients receive high-dose vincristine IV on days 1, 8, and 15 and doxorubicin hydrochloride, dexamethasone, pegaspargase, and methotrexate IT* as in arm I.
  
  
  

   [Note: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 28.]

  Patients in both arms then proceed to intensification therapy 2 (as per their randomized arm in induction therapy 1).




• Intensification therapy 2 (weeks 33-56 or 34-57):
  • Arm I: Once blood counts recover, patients receive high-dose cytarabine IV over 3 hours on days 1 and 2; pegaspargase IM on day 2; low-dose vincristine IV on days 22 and 29; high-dose methotrexate IV on day 22; leucovorin calcium IV or orally beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses; oral mercaptopurine once daily on days 23-27; etoposide phosphate IV over ≥ 1 hour and cyclophosphamide IV over 1 hour on day 29; and methotrexate IT* on day 36. Patients also receive G-CSF IV or SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 42 days for 4 courses (with the exception of IT methotrexate which only repeats for 3 courses).
  
  
  
  • Arm II: Patients receive high-dose cytarabine, high-dose methotrexate, leucovorin calcium, pegaspargase, mercaptopurine, etoposide phosphate, cyclophosphamide, methotrexate IT*, and G-CSF as in arm I. Patients also receive high-dose vincristine IV on days 22 and 29.
  
  
  

   [Note: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 36. Treatment repeats every 6 weeks for 3 courses.]

  Patients in both arms then proceed to maintenance therapy (as per their randomized arm in induction therapy 1).




• Maintenance therapy (week 57-106 or 58-107):
  • Arm I: Patients receive methotrexate IT on day 1* and then orally on days 8, 15, 22, 29, and 36; oral mercaptopurine once daily on days 1-42; oral dexamethasone twice daily on days 1-5; and low-dose vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 70 days for 5 courses.
  
  
  
  • Arm II: Patients receive methotrexate*, mercaptopurine, dexamethasone, and cyclophosphamide as in arm I. Patients also receive high-dose vincristine IV on days 43, 50, 57, and 64.
  
  
  

   [Note: *CNS-positive patients receive methotrexate IT on day 1, instead of oral methotrexate.]

  Beginning in week 1 of the first maintenance therapy course, patients with CNS relapse undergo cranial radiotherapy once daily, 5 days a week, for 10 days. Patients with CNS relapse do not receive any IT therapy during maintenance therapy.

After completion of study therapy, patients are followed periodically for 5 years.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Glen Lew, MD, Protocol chair		Ph: 404-785-3240
Rochelle Yanofsky, MD, Protocol co-chair		Ph: 204-787-4163 Email: rochelle.yanofsky@cancercare.mb.ca

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph:  602-546-0920
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Downey
	Southern California Permanente Medical Group
		Robert Cooper	Ph:  323-783-5307
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Finklestein	Ph:  562-492-1062
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph:  323-361-2529
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Madera
	Children's Hospital Central California
		Vonda Crouse	Ph:  559-353-5480
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
	Sacramento
	Kaiser Permanente Medical Center - Oakland
		Vincent Kiley	Ph:  916-474-2326
	San Diego
	Rady Children's Hospital - San Diego
		Clinical Trials Office - Rady Children's Hospital - San Diego	Ph:  858-966-5934
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	Santa Barbara
	Santa Barbara Cottage Children's Hospital
		Daniel Greenfield	Ph:  805-569-8394
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Children's Hospital Center for Cancer and Blood Disorders
		Kelly Maloney	Ph:  720-777-6673
	Denver
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
Connecticut
	Farmington
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
		Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center	Ph:  800-579-7822
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Clinical Trials Office - Alfred I. duPont Hospital for Children	Ph:  302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Clinical Trials Office - Children's National Medical Center	Ph:  202-884-2549
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System	Ph:  877-680-0008
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Jacksonville
	Nemours Children's Clinic
		Eric Sandler	Ph:  904-697-3793
	Miami
	Baptist-South Miami Regional Cancer Program
		Doured Daghistani	Ph:  305-274-1662
	Miami Children's Hospital
		Enrique Escalon	Ph:  305-662-8360x4960
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	Nemours Children's Clinic - Orlando
		Paul Gordon	Ph:  407-650-7230
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	St. Petersburg
	All Children's Hospital
		Gregory Hale	Ph:  727-767-4176
	Tampa
	St. Joseph's Cancer Institute at St. Joseph's Hospital
		Clinical Trials Office - St. Joseph's Cancer Institute	Ph:  800-882-4123
	West Palm Beach
	Kaplan Cancer Center at St. Mary's Medical Center
		Narayana Gowda	Ph:  561-844-6363
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Howard Katzenstein	Ph:  404-785-0853
	Augusta
	MBCCOP - Medical College of Georgia Cancer Center
		Colleen McDonough	Ph:  706-721-3626
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Eugenia Chang	Ph:  208-381-2731
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman	Ph:  773-880-4598x3270
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Oak Lawn
	Advocate Christ Medical Center
		Sharad Salvi	Ph:  708-684-4094
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
	Springfield
	Simmons Cooper Cancer Institute
		Clinical Trials Office - Simmons Cooper Cancer Institute	Ph:  217-545-7929
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Iowa
	Des Moines
	Blank Children's Hospital
		Clinical Trials Office - Blank Children's Hospital	Ph:  515-241-6729
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Kosair Children's Hospital
		Clinical Trials Office - Kosair Children's Hospital	Ph:  502-629-5500
			Email: CancerResource@nortonhealthcare.org
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
	Scarborough
	Maine Children's Cancer Program at Barbara Bush Children's Hospital
		Eric Larsen	Ph:  207-885-7565
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph Wiley	Ph:  410-601-5864
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Floating Hospital for Children at Tufts - New England Medical Center
		Cynthia Kretschmar	Ph:  617-636-5535
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Satkiran Grewal	Ph:  413-794-5316
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Christopher Keuker	Ph:  508-856-4225
Michigan
	Ann Arbor
	C.S. Mott Children's Hospital at University of Michigan Medical Center
		Clinical Trials Office - C.S. Mott Children's Hospital	Ph:  1-800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Flint
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		David Dickens	Ph:  616-391-2086
	Kalamazoo
	CCOP - Kalamazoo
		Leonard Mattano, Jr.	Ph:  269-341-6350
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center	Ph:  517-334-2765
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail Megason	Ph:  601-984-5220
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-4894
	Kansas City
	Children's Mercy Hospital
		Maxine Hetherington	Ph:  816-234-3265
Nebraska
	Omaha
	Children's Hospital
		Minnie Abromowitch	Ph:  402-955-3950
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph:  702-732-0971
		Jonathan Bernstein	Ph:  702-732-1493
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Clinical Trials Office - Hackensack University Medical Center Cancer Center	Ph:  201-996-2879
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Saint Peter's University Hospital
		Doug Cipkala	Ph:  732-745-6674
	Newark
	Newark Beth Israel Medical Center
		Clinical Trials Office - Newark Beth Israel Medical Center	Ph:  973-926-3136
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary Ann Bonilla	Ph:  973-754-3349
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	NYU Cancer Institute at New York University Medical Center
		Elizabeth Raetz	Ph:  212-263-8400
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Valhalla
	New York Medical College
		Fevzi Ozkaynak	Ph:  914-493-7997
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Greenville
	Leo W. Jenkins Cancer Center at ECU Medical School
		Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School	Ph:  252-744-2391
Ohio
	Akron
	Akron Children's Hospital
		Clinical Trials Office - Akron Children's Hospital	Ph:  330-543-3193
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Rainbow Babies and Children's Hospital
		John Letterio	Ph:  216-844-3345
	Columbus
	Nationwide Children's Hospital
		Amanda Termuhlen	Ph:  614-722-3552
	Dayton
	Children's Medical Center - Dayton
		Emmett Broxson	Ph:  937-641-3111
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene McNall-Knapp	Ph:  405-271-5311
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
Pennsylvania
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	St. Christopher's Hospital for Children
		Clinical Trials Office - St. Christopher's Hospital for Children	Ph:  215-427-8991
	Pittsburgh
	Children's Hospital of Pittsburgh
		Clinical Trials Office - Children's Hospital of Pittsburgh	Ph:  412-692-5573
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Columbia
	Palmetto Health South Carolina Cancer Center
		Clinical Trials Office - Palmetto Health South Carolina Cancer Center	Ph:  803-434-3680
	Greenville
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	T.C. Thompson Children's Hospital
		Manoo Bhakta	Ph:  423-778-7289
	Knoxville
	East Tennessee Children's Hospital
		Ray Pais	Ph:  865-541-8266
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Amarillo
	Texas Tech University Health Sciences Center School of Medicine - Amarillo
		Curtis Turner	Ph:  806-354-5434X264
	Corpus Christi
	Driscoll Children's Hospital
		Clinical Trials Office - Driscoll Children's Hospital	Ph:  361-694-5311
	Dallas
	Medical City Dallas Hospital
		Carl Lenarsky	Ph:  972-566-6647x4439
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Clinical Trials Office - Cook's Children's Medical Center	Ph:  682-885-2103
	Houston
	Baylor University Medical Center - Houston
		Patrick Thompson	Ph:  832-824-4029
	Lubbock
	Covenant Children's Hospital
		Latha Prasannan	Ph:  806-725-4840
	San Antonio
	University of Texas Health Science Center at San Antonio
		Paul Thomas	Ph:  210-704-2187
	Temple
	CCOP - Scott and White Hospital
		Arlynn Mulne	Ph:  254-724-2006
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip Barnette	Ph:  801-662-4700
Virginia
	Norfolk
	Children's Hospital of The King's Daughters
		Eric Lowe	Ph:  757-668-7243
	Roanoke
	Carilion Medical Center for Children at Roanoke Community Hospital
		Mandy Meck	Ph:  540-981-7376
Washington
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
	Tacoma
	Mary Bridge Children's Hospital and Health Center - Tacoma
		Ronald Louie	Ph:  253-403-3481
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Allen Chauvenet	Ph:  304-388-1552
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Bruce Camitta	Ph:  414-456-4106
Australia
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine Cole	Ph:  011-6189340-8238
Canada
British Columbia
	Vancouver
	Children's & Women's Hospital of British Columbia
		Mason Bond	Ph:  604-875-2322
Manitoba
	Winnipeg
	CancerCare Manitoba
		Rochelle Yanofsky	Ph:  204-787-4163
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret Yhap	Ph:  902-470-8778
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Carol Portwine	Ph:  905-521-2100x73464
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Mariana Silva	Ph:  613-5496666x3833
	London
	Children's Hospital of Western Ontario
		A. Cairney	Ph:  519-685-8494
Quebec
	Montreal
	Hopital Sainte Justine
		Yvan Samson	Ph:  418-656-4141x47191
		Yvan Samson	Ph:  514-345-4969
	Montreal Children's Hospital at McGill University Health Center
		Sharon Abish	Ph:  514-412-4400x22219
Saskatchewan
	Regina
	Allan Blair Cancer Centre at Pasqua Hospital
		Mansoor Haq	Ph:  306-766-2498
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Kaiser Ali	Ph:  306-655-2744
Switzerland
	Bern
	Swiss Pediatric Oncology Group Bern
		Roland Ammann	Ph:  41316329372

Related Information

PDQ® clinical trial POG-9412

Registry Information
Official Title		Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Trial Start Date		2007-03-26
Trial Completion Date		2012-02-19 (estimated)
Registered in ClinicalTrials.gov		NCT00381680
Date Submitted to PDQ		2006-07-10
Information Last Verified		2009-07-02
NCI Grant/Contract Number		CA98543

Back to Top