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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01908 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AALL07P1 | Other Identifier | Children's Oncology Group | |
| AALL07P1 | Other Identifier | CTEP | |
| U10CA180886 | U.S. NIH Grant/Contract | View source | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To estimate the toxicity, second complete response (CR2) rate at the end of Block 1 therapy, and 4-month event-free survival (EFS) for pediatric and young adult patients with relapsed acute lymphoblastic leukemia (ALL) treated with bortezomib in combination with intensive re-induction chemotherapy.
II. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination regimen.
SECONDARY OBJECTIVES:
I. To assess minimal residual disease (MRD) in bone marrow following completion of each therapy block.
II. To assess the feasibility of measuring leukemia initiating cells (LIC) in patient samples before and after chemotherapy.
III. To discover biologic pathways associated with response and drug resistance using gene and protein expression profiles at baseline and following initial exposure to chemotherapy.
IV. To determine if bortezomib inhibits lymphoblast nuclear factor (NF)-kappa (k)-B activity in leukemia patients.
OUTLINE:
REINDUCTION BLOCK 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1; prednisone orally (PO) twice daily (BID) on days 1-28; bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11; and pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 2, 8, 15, and 22. Patients with central nervous system (CNS)-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29; patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After completion of reinduction block 1, patients with ALL and M2 or M3 bone marrow proceed directly to reinduction block 2. Patients with ALL and M1 bone marrow or lymphoblastic lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent cerebral spinal fluid (CSF) blasts after 6 doses of TIT or patients with progressive lymphoblastic lymphoma are removed from the study.
REINDUCTION BLOCK 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5; cyclophosphamide IV over 15-30 minutes on days 1-5; bortezomib IV over 3-5 seconds on days 1, 4, and 8; filgrastim (G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts recover*; high-dose methotrexate IV over 24 hours on day 22; and leucovorin calcium PO or IV every 6 hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After completion of reinduction block 2, patients proceed to reinduction block 3 immediately or when blood counts recover. Patients with disease progression are removed from the study.
NOTE: *Patients do not receive G-CSF on day 8.
REINDUCTION BLOCK 3: Patients receive cytarabine IV over 3 hours BID on days 1, 2, 8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10 and continuing until blood counts recover.
After completion of study treatment, patients are followed every 6 months for 3 years and then annually for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs | Experimental | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. |
|
| Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr | Experimental | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. |
|
| Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs | Experimental | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-asparaginase | Drug | Given IM 6000 IU/m2/dose Days 2 and 9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. | The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy. |
| Event Free Survival | Percentage of patients who were event free at 4 months | 4 months after enrollment |
| Toxic Death Rate | The proportion of toxic death rate among all eligible patients. | 4 months |
| Severe Adverse Events (SAE) Rate. | The proportion of SAE rate among all eligible patients | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. | End of Block 1 (Day 36 of Block 1) of re-induction therapy |
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 |
| Measure | Description | Time Frame |
|---|---|---|
| NF-kB Activity | NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. | Up to 5 years |
| Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots |
Inclusion Criteria:
Diagnosis
Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis
Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria; patients must have relapsed or become refractory to conventional therapy
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
At least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy
At least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
No evidence of active graft-vs-host disease (GVHD) and >= 4 months must have elapsed; must not be receiving GVHD prophylaxis
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age, unless elevation due to leukemia infiltration
Shortening fraction of >= 27% by echocardiogram, or
Ejection fraction of >= 50% by gated radionuclide study
No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >= 94% at sea level (> 90% if at high altitude)
No evidence of acute pulmonary infiltrates on chest radiograph
Patients with seizure disorder may be enrolled if on allowed anticonvulsants and well controlled; benzodiazepines and gabapentin are acceptable
Central nervous system (CNS) toxicity =< grade 2
Peripheral nervous system (PNS) toxicity < grade 3
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terzah Horton, MD PhD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957229 | Derived | Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7. | |
| 28419486 | Derived | Hanley MJ, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range. J Clin Pharmacol. 2017 Sep;57(9):1183-1193. doi: 10.1002/jcph.906. Epub 2017 Apr 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| T-cell ALL (Chemotherapy) | Experimental | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. |
|
| T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Experimental | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. |
|
|
| doxorubicin hydrochloride | Drug | Given IV 60 mg/m2/dose on Day 1 |
|
|
| therapeutic hydrocortisone | Drug | Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22 |
|
|
| vincristine sulfate | Drug | Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22 |
|
|
| cytarabine | Drug | Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9 |
|
|
| prednisone | Drug | Given PO or IV 40 mg/m2/day on Days 1-28 |
|
|
| bortezomib | Drug | Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8 |
|
|
| pegaspargase | Drug | Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22 |
|
|
| methotrexate | Drug | Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22 |
|
|
| etoposide phosphate | Drug | Given IV 100 mg/m2/dose on Days 1-5 |
|
|
| cyclophosphamide | Drug | Given IV 440 mg/m2/dose on Days 1-5 |
|
|
| filgrastim | Biological | Given IV or SC 5 micrograms/kg/dose Only on Day 6 |
|
|
| leucovorin calcium | Drug | Given PO or IV 15mg/m2/dose q6h x 3 doses |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| High Dose MTX | Drug | IV 5000 mg/m2/dose Block 2: Day 22 |
|
|
Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. |
| End of Block 2 (Day 36 of Block 2) of re-induction therapy |
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 | Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. | End of Block 3 (Day 36 of Block 3) of re-induction therapy |
Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation. |
| Up to 5 years |
| Change in Stem Cell Percentage | Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test. | Baseline to post-treatment with bortezomib |
| Plasma Concentration-time Profiles | Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age). | Up to day 8 of block 2 |
| Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy. | This outcome measure cannot be reported due to the data used for analysis was not collected. | Day 8 of blocks 1 and 2 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| Southern California Permanente Medical Group | Downey | California | 90242 | United States |
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| City of Hope | Duarte | California | 91010 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Miller Children's Hospital | Long Beach | California | 90806 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Children's Hospital Central California | Madera | California | 93636-8762 | United States |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609-1809 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Childrens Hospital of Orange County | Orange | California | 92868-3874 | United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| University of California at Davis Cancer Center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| University of California San Francisco Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University | Washington D.C. | District of Columbia | 20057 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville South | Jacksonville | Florida | 32207 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| UF Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Saint Joseph Children's Hospital of Tampa | Tampa | Florida | 33607 | United States |
| Saint Mary's Hospital | West Palm Beach | Florida | 33407 | United States |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | United States |
| Memorial University Medical Center | Savannah | Georgia | 31404 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Southern Illinois University | Springfield | Illinois | 62702 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Saint Vincent Hospital and Health Services | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Michigan State University Clinical Center | East Lansing | Michigan | 48824-7016 | United States |
| Hurley Medical Center | Flint | Michigan | 48502 | United States |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Columbia Regional | Columbia | Missouri | 65201 | United States |
| The Childrens Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Saint John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467-2490 | United States |
| Mission Hospital-Memorial Campus | Asheville | North Carolina | 28801 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Tech University Health Science Center-Amarillo | Amarillo | Texas | 79106 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Childrens Hospital-King's Daughters | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Carilion Clinic Children's Hospital | Roanoke | Virginia | 24014 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| West Virginia University Charleston | Charleston | West Virginia | 25304 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6008 | Australia |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3J 3G9 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Chedoke-McMaster Hospitals | Hamilton | Ontario | L8S 4L8 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| Children's Hospital | London | Ontario | N6A 5W9 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H3H 1P3 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| San Jorge Children's Hospital | San Juan | 00912 | Puerto Rico |
| FG001 | Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| FG002 | Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| FG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| FG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| BG001 | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| BG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| BG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| BG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. | The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1. | Posted | Number | Percentage of participants | The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy. |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Event Free Survival | Percentage of patients who were event free at 4 months | The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1. | Posted | Number | Percentage of participants | 4 months after enrollment |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Toxic Death Rate | The proportion of toxic death rate among all eligible patients. | The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2. | Posted | Number | percentage of participants | 4 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Severe Adverse Events (SAE) Rate. | The proportion of SAE rate among all eligible patients | The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2. | Posted | Number | percentage of participants | 4 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. | The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3. | Posted | Number | percentage of participants | End of Block 1 (Day 36 of Block 1) of re-induction therapy |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 | Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. | The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3. | Posted | Number | percentage of participants | End of Block 2 (Day 36 of Block 2) of re-induction therapy |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 | Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. | The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3. | Posted | Number | Percentage of participants | End of Block 3 (Day 36 of Block 3) of re-induction therapy |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | NF-kB Activity | NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. | These were for correlative biology studies and the data were not collected in COG database. | Posted | Up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots | Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation. | These were for correlative biology studies and the data were not collected in COG database. | Posted | Up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Stem Cell Percentage | Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test. | These were for correlative biology studies and the data were not collected in COG database. | Posted | Baseline to post-treatment with bortezomib |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Plasma Concentration-time Profiles | Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age). | These were for correlative biology studies and the data were not collected in COG database. | Posted | Up to day 8 of block 2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy. | This outcome measure cannot be reported due to the data used for analysis was not collected. | Not Posted | Day 8 of blocks 1 and 2 | Participants |
Not provided
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 & higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible & evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. | 2 | 4 | 4 | 4 | ||
| EG001 | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. | 47 | 61 | 58 | 61 | ||
| EG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. | 40 | 49 | 44 | 49 | ||
| EG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. | 18 | 22 | 21 | 22 | ||
| EG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. | 7 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCV4 |
| ||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCV4 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | CTCV4 |
| ||
| Cardiac arrest | Cardiac disorders | CTCV4 |
| ||
| Cardiac disorders - Other, specify | Cardiac disorders | CTCV4 |
| ||
| Heart failure | Cardiac disorders | CTCV4 |
| ||
| Left ventricular systolic dysfunction | Cardiac disorders | CTCV4 |
| ||
| Pericardial tamponade | Cardiac disorders | CTCV4 |
| ||
| Sinus bradycardia | Cardiac disorders | CTCV4 |
| ||
| Sinus tachycardia | Cardiac disorders | CTCV4 |
| ||
| Ventricular tachycardia | Cardiac disorders | CTCV4 |
| ||
| Eye pain | Eye disorders | CTCV4 |
| ||
| Abdominal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Anal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Colitis | Gastrointestinal disorders | CTCV4 |
| ||
| Dental caries | Gastrointestinal disorders | CTCV4 |
| ||
| Diarrhea | Gastrointestinal disorders | CTCV4 |
| ||
| Enterocolitis | Gastrointestinal disorders | CTCV4 |
| ||
| Esophagitis | Gastrointestinal disorders | CTCV4 |
| ||
| Gastric hemorrhage | Gastrointestinal disorders | CTCV4 |
| ||
| Ileus | Gastrointestinal disorders | CTCV4 |
| ||
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCV4 |
| ||
| Mucositis oral | Gastrointestinal disorders | CTCV4 |
| ||
| Nausea | Gastrointestinal disorders | CTCV4 |
| ||
| Oral pain | Gastrointestinal disorders | CTCV4 |
| ||
| Pancreatic necrosis | Gastrointestinal disorders | CTCV4 |
| ||
| Pancreatitis | Gastrointestinal disorders | CTCV4 |
| ||
| Peritoneal necrosis | Gastrointestinal disorders | CTCV4 |
| ||
| Rectal fistula | Gastrointestinal disorders | CTCV4 |
| ||
| Typhlitis | Gastrointestinal disorders | CTCV4 |
| ||
| Vomiting | Gastrointestinal disorders | CTCV4 |
| ||
| Chills | General disorders | CTCV4 |
| ||
| Death NOS | General disorders | CTCV4 |
| ||
| Fever | General disorders | CTCV4 |
| ||
| Flu like symptoms | General disorders | CTCV4 |
| ||
| Hypothermia | General disorders | CTCV4 |
| ||
| Multi-organ failure | General disorders | CTCV4 |
| ||
| Pain | General disorders | CTCV4 |
| ||
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCV4 |
| ||
| Allergic reaction | Immune system disorders | CTCV4 |
| ||
| Cytokine release syndrome | Immune system disorders | CTCV4 |
| ||
| Appendicitis | Infections and infestations | CTCV4 |
| ||
| Appendicitis perforated | Infections and infestations | CTCV4 |
| ||
| Catheter related infection | Infections and infestations | CTCV4 |
| ||
| Encephalitis infection | Infections and infestations | CTCV4 |
| ||
| Enterocolitis infectious | Infections and infestations | CTCV4 |
| ||
| Infections and infestations - Other, specify | Infections and infestations | CTCV4 |
| ||
| Infective myositis | Infections and infestations | CTCV4 |
| ||
| Joint infection | Infections and infestations | CTCV4 |
| ||
| Lung infection | Infections and infestations | CTCV4 |
| ||
| Mucosal infection | Infections and infestations | CTCV4 |
| ||
| Papulopustular rash | Infections and infestations | CTCV4 |
| ||
| Pharyngitis | Infections and infestations | CTCV4 |
| ||
| Sepsis | Infections and infestations | CTCV4 |
| ||
| Sinusitis | Infections and infestations | CTCV4 |
| ||
| Soft tissue infection | Infections and infestations | CTCV4 |
| ||
| Urinary tract infection | Infections and infestations | CTCV4 |
| ||
| Alanine aminotransferase increased | Investigations | CTCV4 |
| ||
| Aspartate aminotransferase increased | Investigations | CTCV4 |
| ||
| Blood bilirubin increased | Investigations | CTCV4 |
| ||
| Cholesterol high | Investigations | CTCV4 |
| ||
| Creatinine increased | Investigations | CTCV4 |
| ||
| Investigations - Other, specify | Investigations | CTCV4 |
| ||
| Lipase increased | Investigations | CTCV4 |
| ||
| Neutrophil count decreased | Investigations | CTCV4 |
| ||
| Platelet count decreased | Investigations | CTCV4 |
| ||
| Serum amylase increased | Investigations | CTCV4 |
| ||
| White blood cell decreased | Investigations | CTCV4 |
| ||
| Acidosis | Metabolism and nutrition disorders | CTCV4 |
| ||
| Anorexia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Dehydration | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypernatremia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypokalemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyponatremia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCV4 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCV4 |
| ||
| Akathisia | Nervous system disorders | CTCV4 |
| ||
| Depressed level of consciousness | Nervous system disorders | CTCV4 |
| ||
| Dysarthria | Nervous system disorders | CTCV4 |
| ||
| Encephalopathy | Nervous system disorders | CTCV4 |
| ||
| Headache | Nervous system disorders | CTCV4 |
| ||
| Memory impairment | Nervous system disorders | CTCV4 |
| ||
| Nervous system disorders - Other, specify | Nervous system disorders | CTCV4 |
| ||
| Neuralgia | Nervous system disorders | CTCV4 |
| ||
| Paresthesia | Nervous system disorders | CTCV4 |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | CTCV4 |
| ||
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCV4 |
| ||
| Seizure | Nervous system disorders | CTCV4 |
| ||
| Stroke | Nervous system disorders | CTCV4 |
| ||
| Syncope | Nervous system disorders | CTCV4 |
| ||
| Anxiety | Psychiatric disorders | CTCV4 |
| ||
| Confusion | Psychiatric disorders | CTCV4 |
| ||
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCV4 |
| ||
| Acute kidney injury | Renal and urinary disorders | CTCV4 |
| ||
| Urinary retention | Renal and urinary disorders | CTCV4 |
| ||
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Capillary leak syndrome | Vascular disorders | CTCV4 |
| ||
| Hypertension | Vascular disorders | CTCV4 |
| ||
| Hypotension | Vascular disorders | CTCV4 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCV4 |
| ||
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCV4 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | CTCV4 |
| ||
| Pericardial effusion | Cardiac disorders | CTCV4 |
| ||
| Ventricular tachycardia | Cardiac disorders | CTCV4 |
| ||
| Conjunctivitis | Eye disorders | CTCV4 |
| ||
| Abdominal distension | Gastrointestinal disorders | CTCV4 |
| ||
| Abdominal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Anal fistula | Gastrointestinal disorders | CTCV4 |
| ||
| Anal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Ascites | Gastrointestinal disorders | CTCV4 |
| ||
| Colitis | Gastrointestinal disorders | CTCV4 |
| ||
| Diarrhea | Gastrointestinal disorders | CTCV4 |
| ||
| Enterocolitis | Gastrointestinal disorders | CTCV4 |
| ||
| Gastric hemorrhage | Gastrointestinal disorders | CTCV4 |
| ||
| Gastrointestinal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCV4 |
| ||
| Ileus | Gastrointestinal disorders | CTCV4 |
| ||
| Mucositis oral | Gastrointestinal disorders | CTCV4 |
| ||
| Nausea | Gastrointestinal disorders | CTCV4 |
| ||
| Oral pain | Gastrointestinal disorders | CTCV4 |
| ||
| Pancreatitis | Gastrointestinal disorders | CTCV4 |
| ||
| Proctitis | Gastrointestinal disorders | CTCV4 |
| ||
| Rectal pain | Gastrointestinal disorders | CTCV4 |
| ||
| Rectal ulcer | Gastrointestinal disorders | CTCV4 |
| ||
| Typhlitis | Gastrointestinal disorders | CTCV4 |
| ||
| Vomiting | Gastrointestinal disorders | CTCV4 |
| ||
| Facial pain | General disorders | CTCV4 |
| ||
| Fatigue | General disorders | CTCV4 |
| ||
| Fever | General disorders | CTCV4 |
| ||
| Infusion related reaction | General disorders | CTCV4 |
| ||
| Pain | General disorders | CTCV4 |
| ||
| Anorectal infection | Infections and infestations | CTCV4 |
| ||
| Appendicitis | Infections and infestations | CTCV4 |
| ||
| Bladder infection | Infections and infestations | CTCV4 |
| ||
| Bronchial infection | Infections and infestations | CTCV4 |
| ||
| Catheter related infection | Infections and infestations | CTCV4 |
| ||
| Conjunctivitis infective | Infections and infestations | CTCV4 |
| ||
| Enterocolitis infectious | Infections and infestations | CTCV4 |
| ||
| Eye infection | Infections and infestations | CTCV4 |
| ||
| Hepatic infection | Infections and infestations | CTCV4 |
| ||
| Infections and infestations - Other, specify | Infections and infestations | CTCV4 |
| ||
| Kidney infection | Infections and infestations | CTCV4 |
| ||
| Lung infection | Infections and infestations | CTCV4 |
| ||
| Nail infection | Infections and infestations | CTCV4 |
| ||
| Paronychia | Infections and infestations | CTCV4 |
| ||
| Periorbital infection | Infections and infestations | CTCV4 |
| ||
| Peritoneal infection | Infections and infestations | CTCV4 |
| ||
| Sepsis | Infections and infestations | CTCV4 |
| ||
| Sinusitis | Infections and infestations | CTCV4 |
| ||
| Skin infection | Infections and infestations | CTCV4 |
| ||
| Soft tissue infection | Infections and infestations | CTCV4 |
| ||
| Splenic infection | Infections and infestations | CTCV4 |
| ||
| Urinary tract infection | Infections and infestations | CTCV4 |
| ||
| Wound infection | Infections and infestations | CTCV4 |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCV4 |
| ||
| Activated partial thromboplastin time prolonged | Investigations | CTCV4 |
| ||
| Alanine aminotransferase increased | Investigations | CTCV4 |
| ||
| Alkaline phosphatase increased | Investigations | CTCV4 |
| ||
| Aspartate aminotransferase increased | Investigations | CTCV4 |
| ||
| Blood bilirubin increased | Investigations | CTCV4 |
| ||
| Creatinine increased | Investigations | CTCV4 |
| ||
| Ejection fraction decreased | Investigations | CTCV4 |
| ||
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCV4 |
| ||
| Fibrinogen decreased | Investigations | CTCV4 |
| ||
| Forced expiratory volume decreased | Investigations | CTCV4 |
| ||
| GGT increased | Investigations | CTCV4 |
| ||
| Investigations - Other, specify | Investigations | CTCV4 |
| ||
| Lipase increased | Investigations | CTCV4 |
| ||
| Lymphocyte count decreased | Investigations | CTCV4 |
| ||
| Lymphocyte count increased | Investigations | CTCV4 |
| ||
| Neutrophil count decreased | Investigations | CTCV4 |
| ||
| Platelet count decreased | Investigations | CTCV4 |
| ||
| Serum amylase increased | Investigations | CTCV4 |
| ||
| Weight loss | Investigations | CTCV4 |
| ||
| White blood cell decreased | Investigations | CTCV4 |
| ||
| Acidosis | Metabolism and nutrition disorders | CTCV4 |
| ||
| Anorexia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Dehydration | Metabolism and nutrition disorders | CTCV4 |
| ||
| Glucose intolerance | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyperuricemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypokalemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hyponatremia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | CTCV4 |
| ||
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCV4 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCV4 |
| ||
| Dizziness | Nervous system disorders | CTCV4 |
| ||
| Headache | Nervous system disorders | CTCV4 |
| ||
| Nervous system disorders - Other, specify | Nervous system disorders | CTCV4 |
| ||
| Peripheral motor neuropathy | Nervous system disorders | CTCV4 |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | CTCV4 |
| ||
| Syncope | Nervous system disorders | CTCV4 |
| ||
| Tremor | Nervous system disorders | CTCV4 |
| ||
| Agitation | Psychiatric disorders | CTCV4 |
| ||
| Anxiety | Psychiatric disorders | CTCV4 |
| ||
| Confusion | Psychiatric disorders | CTCV4 |
| ||
| Delirium | Psychiatric disorders | CTCV4 |
| ||
| Depression | Psychiatric disorders | CTCV4 |
| ||
| Psychosis | Psychiatric disorders | CTCV4 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCV4 |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | CTCV4 |
| ||
| Capillary leak syndrome | Vascular disorders | CTCV4 |
| ||
| Hematoma | Vascular disorders | CTCV4 |
| ||
| Hypertension | Vascular disorders | CTCV4 |
| ||
| Hypotension | Vascular disorders | CTCV4 |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001215 | Asparaginase |
| C087753 | palmitoyl-L-asparaginase |
| D004317 | Doxorubicin |
| D006854 | Hydrocortisone |
| D014750 | Vincristine |
| D003561 | Cytarabine |
| D011241 | Prednisone |
| D000069286 | Bortezomib |
| C042705 | pegaspargase |
| D008727 | Methotrexate |
| C015342 | merphos |
| C061400 | etoposide phosphate |
| D003520 | Cyclophosphamide |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
|
|
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
|
|
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. |
|
|
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
|
| Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs |
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
|
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
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Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG002 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG003 | T-cell ALL (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
| OG004 | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine. L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9 doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1 therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22 vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22 cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9 prednisone: Given PO or IV 40 mg/m2/day on Days 1-28 bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8 pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22 MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22 etopo |
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