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Last Modified: 6/26/2009     First Published: 11/9/2007  
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Phase II Study of Combination Chemotherapy in Adolescents and Young Adults With Newly Diagnosed Acute Lymphoblastic Leukemia

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

Alternate Title

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive16 to 30NCICALGB-10403
CALGB 10403, ECOG C10403, SWOG C10403, NCT00558519

Objectives

  1. To describe the outcomes (i.e., complete response rate, event-free survival, disease-free survival, and overall survival) of adolescents and young adults with newly diagnosed acute lymphoblastic leukemia (ALL) treated with a pediatric chemotherapy regimen by adult hematologists/oncologists at multiple sites.
  2. To describe the toxicities observed in these patients.
  3. To compare the outcomes of patients treated on this protocol with appropriate similar patients (by age and disease characteristics) treated by pediatric oncologists on protocol COG-AALL0232.
  4. To evaluate the adherence of adult hematologists/oncologists and their patients to a "pediatric" ALL treatment regimen and identify reasons for variances.
  5. To analyze and describe the outcomes of patients treated on this study according to pretreatment characteristics such as age, gender, white blood cell count, other hematologic parameters, blood chemistry, immunophenotype, cytogenetics and molecular genetic characteristics, and treatment variables such as treatment site (academic center or community), and protocol adherence.
  6. To analyze and describe the outcomes of patients treated on this study according to baseline psychosocial characteristics, demographics, and family support.

Entry Criteria

Disease Characteristics:

  • Newly diagnosed acute lymphoblastic leukemia (ALL)
    • B-precursor or T-precursor ALL
    • No Burkitt type leukemia (FAB L3; SIg positive; t(8;14) or variant)
    • No known Ph+ ALL at time of diagnosis


  • Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol
    • Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):
      • BCR-ABL fusion transcript determined by FISH or RT-PCR
      • t(9;22)(q34;q11) or variant determined by cytogenetics


  • All CALGB patients are required to participate in CALGB-8461


  • All SWOG patients are required to participate in SWOG-9007


Prior/Concurrent Therapy:

  • No prior therapy for acute leukemia except emergency therapy (i.e., corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys
  • Single-dose intrathecal cytarabine is allowed prior to registration for patient convenience provided systemic chemotherapy begins within 72 hours of intrathecal therapy
  • Prior steroid therapy allowed

Patient Characteristics:

  • ECOG performance status 0-2
  • No Down syndrome

Expected Enrollment

300

Outcomes

Primary Outcome(s)

Complete response rate
Event-free survival
Disease-free survival
Overall survival
Toxicity
Outcomes of adolescent and young adult patients treated on this study compared with those of patients treated per COG-AALL0232
Adherence of adult hematologists/oncologists and their patients to a "pediatric" acute lymphoblastic leukemia treatment regimen and identification of reasons for variances
Outcomes of patients treated on this study according to pretreatment characteristics such as age, gender, white blood cell count, other hematologic parameters, blood chemistry, immunophenotype, cytogenetics and molecular genetic characteristics
Outcomes of patients treated on this study according to treatment variables such as treatment site (academic center or community), and protocol adherence
Analysis and description of the outcomes of patients treated on this study according to baseline psychosocial characteristics, demographics, and family support

Outline

This is a multicenter study.

  • Remission induction therapy: Patients receive intrathecal (IT) cytarabine on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally twice daily on days 1-14; daunorubicin hydrochloride IV on days 1, 8, 15, and 22; pegaspargase IV or intramuscularly (IM) on day 4 or 5 or 6; and IT methotrexate on days 8 and 29*. Patients undergo bone marrow aspirate (BMA) and biopsy on day 29 to assess induction response and minimal residual disease status. Patients with M1 marrow (< 1% lymphoblasts) proceed to remission consolidation therapy. Patients with M2 marrow (> 5% but < 25% lymphoblasts) proceed to extended remission induction therapy. Patients with M3 marrow are removed from protocol therapy.

     [Note: *Patients with CNS3 disease also receive IT methotrexate on days 15 and 22.]



  • Extended remission induction therapy: Patients receive dexamethasone IV or orally twice daily on days 1-14; vincristine IV on days 1 and 8; pegaspargase IM or IV on day 4 or 5 or 6; and daunorubicin hydrochloride IV on day 1. Patients undergo BMA and biopsy on day 15. Patients with M1 marrow proceed to remission consolidation therapy. Patients with M2 or M3 bone marrow are removed from protocol therapy.


  • Remission consolidation therapy: Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM or IV on days 15 and 43; and IT methotrexate on days 1, 8, 15*, and 22*. Once blood counts recover, patients proceed to interim maintenance therapy.

     [Note: *Patients with CNS3 disease do not receive IT methotrexate on days 15 and 22.]



  • Interim maintenance therapy: Patients receive vincristine IV and methotrexate (Capizzi methotrexate) IV on days 1, 11, 21, 31, and 41, pegaspargase IM or IV on days 2 and 22, and IT methotrexate on days 1 and 31. Once blood counts recover (ANC ≥ 750/mm3 and platelet count ≥ 75,000/mm3), patients proceed to delayed intensification therapy.


  • Delayed intensification therapy: Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone IV or orally twice daily on days 1-7 and 15-21; doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV on day 4 or 5 or 6 AND day 43; cyclophosphamide IV on day 29; cytarabine IV or SC on days 29-32 and 36-39; oral thioguanine on days 29-42; and IT methotrexate on days 1, 29, and 36. Once blood counts recover, patients proceed to maintenance therapy.


  • Maintenance chemotherapy: Patients receive vincristine IV on days 1, 29, and 57; dexamethasone IV or orally twice daily on days 1-5, 29-33, and 57-61; mercaptopurine orally on days 1-84; IT methotrexate on day 1*; and oral methotrexate on days 8, 15, 22, 29**, 36, 43, 50, 57, 64, 71, and 78.

    Treatment repeats every 12 weeks for 2 years from the start of interim maintenance (for female patients) or 3 years from the start of interim maintenance (for male patients).

     [Note: *IT methotrexate is also given on day 29 of the first 4 courses of maintenance therapy.]

     [Note: **Oral methotrexate is held on day 29 of the first 4 courses of maintenance therapy (when IT methotrexate is given).]



  • Radiotherapy: During the first course of maintenance therapy, patients with testicular disease undergo concurrent radiotherapy to the testes 5 days a week for 2.5 weeks (total dose 2400 cGy given in 12 daily fractions); patients with CNS3 disease undergo concurrent cranial radiotherapy 5 days a week for 2 weeks (total dose of 1800 cGy given in 10 daily fractions); and patients with T-cell ALL undergo concurrent cranial radiotherapy (total dose of 2400 cGy given in 10 daily fractions) 5 days a week for 2 weeks.


After completion of study treatment, patients are followed every 1-3 months for 3 years, and then every 6 months for 7 years.

Related Publications

Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Richard Larson, MD, Protocol chair
Ph: 773-702-6783; 888-824-0200
John Grecula, MD, Protocol co-chair
Ph: 614-293-3244

Eastern Cooperative Oncology Group

Selina Luger, MD, Protocol chair
Ph: 215-662-6348

Southwest Oncology Group

Anjali Advani, MD, Protocol chair
Ph: 216-445-9354; 800-862-7798
Email: advania@ccf.org

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 Rose Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Anthony Central Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Thornton
 North Suburban Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
Illinois
  Chicago
 Hematology and Oncology Associates
 Clinical Trails Office - Hematology and Oncology Associates
Ph: 312-695-1301
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
 Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Joliet
 Midwest Center for Hematology/Oncology
 Jessica Altman
Ph: 815-740-1400
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Jessica Altman
Ph: 847-367-6781
  Naperville
 La Grange Oncology Associates - Geneva
 Jessica Altman
Ph: 630-232-0610
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Jessica Altman
Ph: 847-827-9060
  Skokie
 Hematology Oncology Associates - Skokie
 Jessica Altman
Ph: 847-568-9930
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard Gross, MD
Ph: 937-832-1093
  Fort Wayne
 Fort Wayne Medical Oncology and Hematology
 Sreenivasa Nattam, MD
Ph: 260-484-8830
  Richmond
 Reid Hospital & Health Care Services
 Howard Gross, MD
Ph: 937-832-1093
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  Bettendorf
 Hematology Oncology Associates of the Quad Cities
 Shobha Chitneni, MD, MBBS
Ph: 563-355-7733
  Des Moines
 CCOP - Iowa Oncology Research Association
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Capitol Hospital
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Kansas
  Anthony
 Hospital District Sixth of Harper County
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Southwest Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Topeka
 Cotton-O'Neil Cancer Center
 Clinical Trials Office - Cotton-O'Neil Cancer Center
Ph: 785-270-4963
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Wesley Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center
Ph: 800-888-8823
 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
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Stephen Grubbs, MD
Ph: 302-366-1200
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Clinical Trials Office - University of Michigan Comprehensive Cancer Center
Ph: 800-865-1125
Minnesota
  Minneapolis
 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
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Clinical Trial Office - Ellis Fischel Cancer Center
Ph: 573-882-4894
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Geoffrey Uy
Ph: 314-747-7222
800-600-3606
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
 Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
 Northern Rockies Radiation Oncology Center
 Benjamin Marchello, MD
Ph: 406-238-6290
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  Butte
 St. James Healthcare Cancer Care
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Benjamin Marchello, MD
Ph: 406-238-6290
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
  Havre
 Northern Montana Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Glacier Oncology, PLLC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Medical Oncology at KRMC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Community Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
 Guardian Oncology and Center for Wellness
 Benjamin Marchello, MD
Ph: 406-238-6290
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Ph: 406-329-7029
 Montana Cancer Specialists at Montana Cancer Center
 Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center
Ph: 406-238-6962
New Jersey
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
New York
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  Lake Success
 Monter Cancer Center of the North Shore-LIJ Health System
 Jonathan Kolitz, MD
Ph: 516-562-8970
  Manhasset
 CCOP - North Shore University Hospital
 Jonathan Kolitz, MD
Ph: 516-562-8970
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital
Ph: 516-734-8900
  New Hyde Park
 Long Island Jewish Medical Center
 Jonathan Kolitz, MD
Ph: 516-562-8970
  New York
 New York Weill Cornell Cancer Center at Cornell University
 Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University
Ph: 212-746-1848
North Carolina
  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
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
 Email: osu@emergingmed.com
  Dayton
 CCOP - Dayton
 Howard Gross, MD
Ph: 937-832-1093
 David L. Rike Cancer Center at Miami Valley Hospital
 Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital
Ph: 937-208-2079
 Good Samaritan Hospital
 Howard Gross, MD
Ph: 937-832-1093
 Grandview Hospital
 Howard Gross, MD
Ph: 937-832-1093
 Samaritan North Cancer Care Center
 Howard Gross, MD
Ph: 937-832-1093
  Findlay
 Blanchard Valley Medical Associates
 Howard Gross, MD
Ph: 937-832-1093
  Franklin
 Middletown Regional Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Greenville
 Wayne Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Independence
 Cleveland Clinic Cancer Center
 George Budd, MD
Ph: 216-444-6480
  Kettering
 Charles F. Kettering Memorial Hospital
 Clinical Trials Office - Charles F. Kettering Memorial Hospital
Ph: 937-298-3399 ext. 57556
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center
Ph: 937-440-4842
  Wilmington
 Clinton Memorial Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Wooster
 Cleveland Clinic - Wooster
 Clinical Trials Office - Cleveland Clinic - Wooster
Ph: 800-862-7798
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard Gross, MD
Ph: 937-832-1093
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
  Lewistown
 Lewistown Hospital
 Witold Rybka, MD, FRCPC
Ph: 717-531-1050
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania
Ph: 800-474-9892
  State College
 Mount Nittany Medical Center
 Witold Rybka, MD, FRCPC
Ph: 717-531-1050
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
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Loren Tschetter, MD
Ph: 605-328-8000
 Medical X-Ray Center, PC
 Loren Tschetter, MD
Ph: 605-328-8000
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Vermont
  Berlin
 Mountainview Medical
 Barbara Grant, MD
Ph: 802-847-8400
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center
Ph: 804-628-1939
Washington
  Bellingham
 St. Joseph Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Bremerton
 Olympic Hematology and Oncology
 Saul Rivkin, MD
Ph: 206-386-2441
  Kennewick
 Columbia Basin Hematology
 Saul Rivkin, MD
Ph: 206-386-2441
  Seattle
 Fred Hutchinson Cancer Research Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Group Health Central Hospital
 Clinical Trials Office - Group Health Central Hospital
Ph: 206-287-2900
 Harborview Medical Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Minor and James Medical, PLLC
 Saul Rivkin, MD
Ph: 206-386-2441
 Polyclinic First Hill
 Saul Rivkin, MD
Ph: 206-386-2441
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Saul Rivkin, MD
Ph: 206-386-2441
 University Cancer Center at University of Washington Medical Center
 Clinical Trials Office - University Cancer Center at University of Washington Medical Center
Ph: 206-616-8289
  Spokane
 Cancer Care Northwest - Spokane South
 Clinical Trials Office - Cancer Care Northwest - Spokane South
Ph: 509-228-1083
Peru
  Lima
 Instituto Nacional de Enfermedades Neoplasicas
 Carlos Vallejos-Sologuren, MD, FACP
Ph: 511-620-4995

Related Information

PDQ® clinical trial CALGB-C10001
PDQ® clinical trial COG-AALL0232
PDQ® clinical trial CALGB-8461

Registry Information
Official Title An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
Trial Start Date 2007-10-15
Trial Completion Date 2012-09-18 (estimated)
Registered in ClinicalTrials.gov NCT00558519
Date Submitted to PDQ 2007-10-23
Information Last Verified 2009-06-26
NCI Grant/Contract Number CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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