Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
-
Compare the efficacy and toxicity of short methotrexate infusion vs longer infusion in patients with low-risk acute lymphoblastic leukemia.
-
Compare the efficacy of these regimens of methotrexate, with or without multidrug intensification, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to genetics (stratum 1: trisomy 4/10 but not TEL/AML1 vs stratum 2: TEL/AML1 with or without trisomy 4/10).
All patients receive induction therapy (weeks 1-4) on another protocol (POG-9900).
Stratum 1
-
Consolidation therapy begins on week 5. Patients are randomized to arm I or II.
-
Arm I: Patients receive methotrexate (MTX) IV over 24 hours on day 1 and oral leucovorin calcium (CF) every 6 hours for 3 doses beginning 42 hours after initiation of MTX infusion during weeks 7, 10, 13, 16, and 19.
-
Arm II: Patients receive MTX IV over 4 hours on day 1 and oral CF as in arm I during weeks 7, 10, 13, 16, and 19.
-
Patients in arms I and II also receive MTX intrathecally (IT) on weeks 7, 10, 13, 16, 19, and 22; oral mercaptopurine (6-MP) daily on weeks 5-24; oral dexamethasone (DM) twice daily on days 1-7 of weeks 8 and 17; and vincristine (VCR) IV on day 1 of weeks 8, 9, 17, and 18.
Stratum 2
-
Consolidation therapy begins on week 5 and delayed intensification therapy begins on week 16. Patients are randomized to delayed intensification or no delayed intensification. Patients randomized to no delayed intensification are then randomized to consolidation therapy on arm I or II. Patients randomized to delayed intensification are then randomized to arm III or IV. Patients with trisomy 4/10 are not randomized to arms III and IV.
-
Arm III: Patients receive MTX IV and CF as in arm I on weeks 7, 10, 13, 24, 27, and
- Arm IV: Patients receive MTX IV and CF as in arm II on weeks 7, 10, 13, 24, 27, and
- Patients in arms III and IV also receive oral 6-MP daily on weeks 5-13 and then beginning on week 24 and continuing until the end of consolidation; MTX IT on weeks 7, 10, 13, 16, 20, 21, and 30; oral DM twice daily on days 1-7 of weeks 8, 16-18, and 28; VCR IV on day 1 of weeks 8, 9, 16-18, 28, and 29; pegaspargase intramuscularly on week 16; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV on day 1 of week 20; cytarabine IV or subcutaneously on days 2-5 of weeks 20 and 21; and oral thioguanine daily on days 1-14 of weeks 20 and 21.
All patients then receive continuation therapy beginning on week 25 for arms I and II and week 33 for arms III and IV and continuing until week 130 for all arms.
Continuation
-
Arms I and II: Patients receive oral 6-MP daily on weeks 25-130; oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 25, 41, 57, 73, 89, and 105; oral MTX weekly on weeks 25-130 (except during weeks of IT MTX); and MTX IT on weeks 25, 37, 49, 61, 73, 85, 97, and 109.
-
Arms III and IV: Patients receive oral 6-MP daily on weeks 33-130; oral DM twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41, 57, 73, 89, and 105; oral MTX weekly on weeks 33-130 (except during weeks of IT MTX); and MTX IT on weeks 37, 49, 61, 73, 85, 97, and 109.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total 902 patients will be accrued for this study within 3.22 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I: (combination chemotherapy) CONSOLIDATION: Pts receive Methotrexate(MTX) IV over 24 hrs on day 1 and oral leucovorin calcium (CF) every 6 hrs for 3 doses at 42 hours after initiation of MTX infusion during weeks 7, 10, 13, 16, and 19. Pts also receive MTX IT on wks 7, 10, 13, 16, 19, and 22; oral mercaptopurine(6-MP) daily wks 5-24; oral dexamethasone (DM) 2x on days 1-7 of wks 8 and 17; and vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 17, and 18. CONTINUATION: Pts receive oral 6-MP daily on wks 25-130; oral DM twice a day on days 1-7 and vincristine sulfate (VCR) IV on days 1 and 8 during wks 25, 41, 57, 73, 89, and 105; oral MTX on wks 25-130 (except during wks of IT MTX); and MTX IT on wks 25, 37, 49, 61, 73, 85, 97, and 109. |
Drug: dexamethasone
Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
Other Names:
Drug: leucovorin calcium
Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
Other Names:
Drug: mercaptopurine
An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
Other Names:
Drug: methotrexate
A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: Arm II (combination chemotherapy) CONSOLIDATION: Pts receive methotrexate (MTX) IV over 4 hrs on day 1 and oral leucovorin calcium (CF) during wks 7, 10, 13, 16, and 19. Pts also receive MTX IT on wks 7, 10, 13, 16, 19, and 22; oral mercaptopurine (6-MP) daily on wks 5-24; oral dexamethasone (DM) 2x on days 1-7 of wks 8 and 17; and vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 17, and 18. CONTINUATION: Pts receive oral 6-MP daily on wks 25-130; oral DM 2x on days 1-7 and vincristine sulfate (VCR) IV on days 1 and 8 during wks 25, 41, 57, 73, 89, and 105; oral MTX weekly on wks 25-130 (except during wks of IT MTX); and MTX IT on wks 25, 37, 49, 61, 73, 85, 97, and 109. |
Drug: dexamethasone
Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
Other Names:
Drug: leucovorin calcium
Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
Other Names:
Drug: mercaptopurine
An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
Other Names:
Drug: methotrexate
A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: Arm III (combination chemotherapy) CONSOLIDATION: Pts receive methotrexate (MTX) IV and leucovorin calcium (CF) as in arm I on wks 7, 10, 13, 24, 27, and 30. Pts also receive oral mercaptopurine (6-MP) daily on wks 5-13 and then on wk 24 and continuing until the end of consolidation; MTX IT on wks 7, 10, 13, 16, 20, 21, and 30; oral dexamethasone (DM) twice daily on days 1-7 of wks 8, 16-18, and 28; vincristine sulfate (VCR) IV on day 1 of wks 8, 9, 16-18, 28, and 29; pegaspargase intramuscularly on wk 16; daunorubicin hydrochloride IV on day 1 of wks 16-18; cyclophosphamide IV on day 1 of wk 20; cytarabine IV or subcutaneously on days 2-5 of wks 20 and 21; and oral thioguanine daily on days 1-14 of wks 20 and 21. CONTINUATION: Pts receive oral 6-MP daily on wks 33-130; oral dexamethasone (DM) twice a day on days 1-7 and VCR IV on days 1 and 8 during wks 41, 57, 73, 89, and 105; oral MTX weekly on wks 33-130 (except during wks of IT MTX); and MTX IT on wks 37, 49, 61, 73, 85, 97, and 109. |
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
Other Names:
Drug: leucovorin calcium
Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
Other Names:
Drug: mercaptopurine
An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
Other Names:
Drug: methotrexate
A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
Other Names:
Drug: pegaspargase
E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.
Other Names:
Drug: thioguanine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
| Experimental: .Arm IV (combination chemotherapy) CONSOLIDATION: Pts receive methotrexate (MTX) and leucovorin calcium (CF) on wks 7, 10, 13, 24, 27, and 30. Pts receive mercaptopurine(6-MP) daily weeks 5-13 then beginning wk 24 and continuing until end of consolidation; MTX on wks 7, 10, 13, 16, 20, 21, and 30; dexamethasone (DM) 2x daily on days 1-7 of wks 8, 16-18, and 28; vincristine sulfate (VCR) day 1 of wks 8, 9, 16-18, 28, and 29; pegaspargase on wk 16; daunorubicin hydrochloride on day 1 of wks 16-18; cyclophosphamide on day 1 of wk 20; cytarabine on days 2-5 of wks 20 and 21; thioguanine daily on days 1-14 of wks 20 and 21. CONTINUATION: Pts receive mercaptopurine(6-MP) daily on weeks 33-130; oral dexamethasone (DM) twice a day on days 1-7 and VCR IV on days 1 and 8 during weeks 41, 57, 73, 89, and 105; oral MTX weekly on weeks 33-130 (except during weeks of IV MTX); and IV MTX on weeks 37, 49, 61, 73, 85, 97, and 109. |
Drug: cyclophosphamide
Given IV
Other Names:
Drug: cytarabine
Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: dexamethasone
Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.
Other Names:
Drug: leucovorin calcium
Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)
Other Names:
Drug: mercaptopurine
An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine
Other Names:
Drug: methotrexate
A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis
Other Names:
Drug: pegaspargase
E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.
Other Names:
Drug: thioguanine
Given orally
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Event-free survival [4 years]
The test statistic will compare Kaplan-Meier curves with sample size derived from a modification of the Makuch-Simon method for historical controls
- Occurrence of anticipated failures [Up to 7 years]
An O'Brien-Fleming analysis will be conducted, with significance declared if the observed logrank Z-statistic exceeds the z/sqrt(IF), where IF=fraction of anticipated failures that have occurred and z=critical value of the final analysis.
- Grade 3 or greater CNS toxicity rates assessed using NCI CTC version 2.0 [Up to 7 years]
Secondary Outcome Measures
- Measures of laboratory factors (other than MRD) [Up to 7 years]
Cox multiple regression will be utilized.
- Homocysteine levels [Up to 7 years]
Will be correlated to acute neurotoxicity by Cox regression.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of B-cell precursor acute lymphoblastic leukemia
-
Registered on POG-9900 Classification Study
-
Registered within 7 days of documenting complete response (CR) after induction therapy on day 29 or, if 2 more weeks of induction are required, within 7 days of CR determination
-
Classified as low-risk:
-
WBC less than 50,000/mm^3
-
Age 1 to 9
-
No adverse translocations [E2A-PBX1, t(1;19) or BCR/ABL, t(9;22); and MLL rearrangements]
-
No CNS 3 disease (CSF WBC at least 5/mm^3 with blasts present)
-
No testicular disease
-
At least one of the following present:
-
TEL/AML1, t(12;21)
-
Simultaneous trisomy of chromosomes 4 and 10
PATIENT CHARACTERISTICS:
Age:
- 1 to 9
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
-
Not pregnant or nursing
-
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | University of South Alabama Cancer Research Institute | Mobile | Alabama | United States | 36604 |
| 3 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 4 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 5 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
| 6 | Stanford Cancer Center at Stanford University Medical Center | Palo Alto | California | United States | 94304-1812 |
| 7 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 8 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 9 | Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego | California | United States | 92120 |
| 10 | Children's Hospital and Health Center - San Diego | San Diego | California | United States | 92123-4282 |
| 11 | Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California | United States | 95051-5386 |
| 12 | Yale Comprehensive Cancer Center | New Haven | Connecticut | United States | 06520-8064 |
| 13 | Broward General Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 14 | Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 15 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610-0296 |
| 16 | Joe DiMaggio Children's Hospital at Memorial | Hollywood | Florida | United States | 33021 |
| 17 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
| 18 | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | United States | 30101 |
| 19 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 20 | Baptist-South Miami Regional Cancer Program | Miami | Florida | United States | 33176-2197 |
| 21 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
| 22 | Nemours Children's Clinic-Orlando | Orlando | Florida | United States | 32806 |
| 23 | Sacred Heart Children's Hospital | Pensacola | Florida | United States | 32504 |
| 24 | All Children's Hospital | St. Petersburg | Florida | United States | 33701 |
| 25 | St. Joseph's Children's Hospital of Tampa | Tampa | Florida | United States | 33677-4227 |
| 26 | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | United States | 33407 |
| 27 | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta | Georgia | United States | 30342 |
| 28 | MBCCOP-Medical College of Georgia Cancer Center | Augusta | Georgia | United States | 30912-4000 |
| 29 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 30 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
| 31 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 32 | Children's Memorial Hospital - Chicago | Chicago | Illinois | United States | 60614 |
| 33 | Advocate Hope Children's Hospital | Oak Lawn | Illinois | United States | 60453 |
| 34 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 35 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
| 36 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 37 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 38 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 39 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 40 | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana | United States | 70112 |
| 41 | Children's Hospital of New Orleans | New Orleans | Louisiana | United States | 70118 |
| 42 | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 43 | Pediatric Specialty Clinic at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 44 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074-9308 |
| 45 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201-1595 |
| 46 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-7223 |
| 47 | Walter Reed Army Medical Center | Silver Spring | Maryland | United States | 20910 |
| 48 | Floating Hospital for Children | Boston | Massachusetts | United States | 02111 |
| 49 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114-2696 |
| 50 | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 51 | UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 52 | Children's Hospital of Michigan | Detroit | Michigan | United States | 48201 |
| 53 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 54 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 55 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 56 | Keesler Medical Center - Keesler Air Force Base | Keesler AFB | Mississippi | United States | 39534-2511 |
| 57 | University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 58 | Cardinal Glennon Children's Hospital | Saint Louis | Missouri | United States | 63104 |
| 59 | St. Louis Children's Hospital | Saint Louis | Missouri | United States | 63110 |
| 60 | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 61 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 62 | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | United States | 87131 |
| 63 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 64 | Schneider Children's Hospital | New Hyde Park | New York | United States | 11040 |
| 65 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 66 | Beth Israel Medical Center - Singer Division | New York | New York | United States | 10128 |
| 67 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 68 | Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York | United States | 11794-8174 |
| 69 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 70 | Mission Hospitals - Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 71 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 72 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233 |
| 73 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 74 | Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville | North Carolina | United States | 27858-4354 |
| 75 | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | United States | 27157-1081 |
| 76 | Oklahoma University Medical Center | Oklahoma City | Oklahoma | United States | 73104 |
| 77 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 78 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
| 79 | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | United States | 97227 |
| 80 | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134-1095 |
| 81 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 82 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 83 | Children's Hospital of Greenville Hospital System | Greenville | South Carolina | United States | 29605 |
| 84 | East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City | Tennessee | United States | 37614-0622 |
| 85 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 86 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78466 |
| 87 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 88 | Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390-9063 |
| 89 | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | United States | 76104 |
| 90 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
| 91 | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas | United States | 77030-2399 |
| 92 | San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas | United States | 78236 |
| 93 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78207 |
| 94 | MBCCOP - South Texas Pediatrics | San Antonio | Texas | United States | 78229-3900 |
| 95 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 96 | Center for Cancer Prevention and Care at Scott and White Clinic | Temple | Texas | United States | 76508 |
| 97 | Vermont Cancer Center at University of Vermont | Burlington | Vermont | United States | 05401-3498 |
| 98 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 99 | INOVA Fairfax Hospital | Falls Church | Virginia | United States | 22042-3300 |
| 100 | Naval Medical Center - Portsmouth | Portsmouth | Virginia | United States | 23708-5100 |
| 101 | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | United States | 23298-0121 |
| 102 | Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | United States | 24029 |
| 103 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-0001 |
| 104 | West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia | United States | 25302 |
| 105 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506-9300 |
| 106 | St. Vincent Hospital | Green Bay | Wisconsin | United States | 54307-9070 |
| 107 | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | United States | 54449 |
| 108 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 109 | Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 110 | Royal Children's Hospital | Brisbane | Queensland | Australia | 4029 |
| 111 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 112 | Alberta Children's Hospital | Calgary | Alberta | Canada | T2T 5C7 |
| 113 | Cross Cancer Institute at University of Alberta | Edmonton | Alberta | Canada | T6G 1Z2 |
| 114 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8S 4J9 |
| 115 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 116 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 117 | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | Canada | H3G 1A4 |
| 118 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 119 | Centre de Recherche du Centre Hospitalier de l'Universite Laval | Sainte Foy | Quebec | Canada | GIV 4G2 |
| 120 | University Medical Center Groningen | Groningen | Netherlands | 9700 RB | |
| 121 | San Jorge Children's Hospital | Santurce | Puerto Rico | 00912 | |
| 122 | Swiss Pediatric Oncology Group Bern | Bern | Switzerland | CH 3010 | |
| 123 | Swiss Pediatric Oncology Group Geneva | Geneva | Switzerland | CH 1211 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Paul L. Martin, MD, Duke Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Borowitz MJ, Devidas M, Hunger SP, Bowman WP, Carroll AJ, Carroll WL, Linda S, Martin PL, Pullen DJ, Viswanatha D, Willman CL, Winick N, Camitta BM; Children's Oncology Group. Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood. 2008 Jun 15;111(12):5477-85. doi: 10.1182/blood-2008-01-132837. Epub 2008 Apr 3.
- Borowitz MJ, Devidas M, Hunger SP, et al.: Prognostic signficance of end consolidation minimal residual disease (MRD) in childhood acute lymphoblastic leukemia (ALL): A report from the Children's Oncology Group (COG). [Abstract] J Clin Oncol 26 (Suppl 15): A-10000, 2008.
- Davies SM, Borowitz MJ, Rosner GL, Ritz K, Devidas M, Winick N, Martin PL, Bowman P, Elliott J, Willman C, Das S, Cook EH, Relling MV. Pharmacogenetics of minimal residual disease response in children with B-precursor acute lymphoblastic leukemia: a report from the Children's Oncology Group. Blood. 2008 Mar 15;111(6):2984-90. doi: 10.1182/blood-2007-09-114082. Epub 2008 Jan 8.
- Hinds PS, Hockenberry MJ, Gattuso JS, Srivastava DK, Tong X, Jones H, West N, McCarthy KS, Sadeh A, Ash M, Fernandez C, Pui CH. Dexamethasone alters sleep and fatigue in pediatric patients with acute lymphoblastic leukemia. Cancer. 2007 Nov 15;110(10):2321-30.
- Rabin KR, Gramatges MM, Borowitz MJ, Palla SL, Shi X, Margolin JF, Zweidler-McKay PA. Absolute lymphocyte counts refine minimal residual disease-based risk stratification in childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Sep;59(3):468-74. doi: 10.1002/pbc.23395. Epub 2011 Nov 18.
- Winick N, Martin PL, Devidas M, et al.: Delayed intensification (DI) enhances event-free survival (EFS) of children with B-precursor acute lymphoblastic leukemia (ALL) who received intensification therapy with six courses of intravenous methotrexate (MTX): POG 9904/9905: a Children's Oncology Group study (COG). [Abstract] Blood 110 (11): A-583, 2007.
- Xu H, Cheng C, Devidas M, Pei D, Fan Y, Yang W, Neale G, Scheet P, Burchard EG, Torgerson DG, Eng C, Dean M, Antillon F, Winick NJ, Martin PL, Willman CL, Camitta BM, Reaman GH, Carroll WL, Loh M, Evans WE, Pui CH, Hunger SP, Relling MV, Yang JJ. ARID5B genetic polymorphisms contribute to racial disparities in the incidence and treatment outcome of childhood acute lymphoblastic leukemia. J Clin Oncol. 2012 Mar 1;30(7):751-7. doi: 10.1200/JCO.2011.38.0345. Epub 2012 Jan 30.
- 9904
- COG-P9904
- POG-9904
- CDR0000067657
- NCI-2012-02321