Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00720109 |
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Recruitment Status :
Completed
First Posted : July 22, 2008
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
- Study Details
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- Study Results
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Brief Summary:
This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib 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 dasatinib together with combination chemotherapy may kill more cancer cells.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia | Drug: Asparaginase Drug: Cyclophosphamide Drug: Cytarabine Drug: Dasatinib Drug: Daunorubicin Hydrochloride Drug: Dexamethasone Drug: Etoposide Biological: Filgrastim Drug: Hydrocortisone Sodium Succinate Drug: Ifosfamide Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Drug: Mercaptopurine Drug: Methotrexate Drug: Methylprednisolone Drug: Pegaspargase Drug: Prednisone Radiation: Radiation Therapy Drug: Vincristine Sulfate | Phase 2 Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | September 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dasatinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (enzyme inhibitor therapy and chemotherapy)
See Detailed Description
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Drug: Asparaginase
Given IT
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Cytarabine Given IT or IV
Other Names:
Drug: Dasatinib Given PO
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given IV or PO
Other Names:
Drug: Etoposide Given IV
Other Names:
Biological: Filgrastim Given IV or SC
Other Names:
Drug: Hydrocortisone Sodium Succinate Given IT
Other Names:
Drug: Ifosfamide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Leucovorin Calcium Given IV or PO
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT, PO, or IV
Other Names:
Drug: Methylprednisolone Given IV
Other Names:
Drug: Pegaspargase Given IM
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Radiation: Radiation Therapy Some patients undergo cranial RT
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Primary Outcome Measures :
- Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy [ Time Frame: At 3 years ]Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.
- Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events [ Time Frame: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1) ]Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)
Secondary Outcome Measures :
- Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy [ Time Frame: At the end of induction therapy (at 5 weeks) ]Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.
- Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation [ Time Frame: At end of consolidation (at 11 weeks) ]A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.
- Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) [ Time Frame: From the time entry on study to first event or date of last follow-up, assessed up to 7 years ]An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.
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| Ages Eligible for Study: | 2 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Newly diagnosed acute lymphoblastic leukemia (ALL)
- Definitive evidence of BCR-ABL fusion (Philadelphia chromosome positive [PH+]) from an approved Children's Oncology Group (COG) cytogenetics laboratory
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Meets one of the following criteria:
- Concurrent enrollment on Clusters of Orthologous Groups (COG)-AALL03B1 (or a successor trial) AND COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial
- Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND scheduled to receive a 3 or 4-drug standard induction regimen
- Concurrent enrollment on a Dana-Farber Cancer Institute (DFCI) Childhood ALL Consortium trial (or scheduled to be treated as per a DFCI Childhood ALL Consortium induction regimen)
- All patients must have definitive evidence of BCR-ABL fusion from an approved COG cytogenetics laboratory; patients may NOT have received Day 15 of Induction chemotherapy (or day 18 vincristine if enrolled on a DFCI Childhood ALL Consortium trial) prior to enrollment on AALL0622
- Patients must have a performance status of 0, 1 or 2 at completion of two weeks of Induction; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
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Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or maximum serum creatinine based on age and gender as follows:
- 0.4 mg/dL (for patients 1 to 5 months of age)
- 0.5 mg/dL (for patients 6 to 11 months of age)
- 0.6 mg/dL (for patients 1 year of age)
- 0.8 mg/dL (for patients 2 to 5 years of age)
- 1.0 mg/dL (for patients 6 to 9 years of age)
- 1.2 mg/dL (for patients 10 to 12 years of age)
- 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients >= 16 years of age)
- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN for age
- Shortening fraction >= 27% by echocardiogram or ejection fraction >= 50% by gated radionuclide study
- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided
- Patients will start AALL0622 therapy on day 15 of induction therapy (or day 18 if enrolled on a DFCI Childhood ALL Consortium trial); patients must have received the first 2 weeks of Induction therapy
Exclusion Criteria:
- Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method
- Female patients who are lactating must agree to stop breast-feeding
- Patients with Down syndrome
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Patients with any clinically significant cardiovascular disease including the following:
- Myocardial infarction or ventricular tachyarrhythmia within 6 months
- Ejection fraction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720109
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Locations
| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama at Birmingham Cancer Center | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix Childrens Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| The University of Arizona Medical Center-University Campus | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| Miller Children's and Women's Hospital Long Beach | |
| Long Beach, California, United States, 90806 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States, 90095 | |
| Mattel Children's Hospital UCLA | |
| Los Angeles, California, United States, 90095 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93636-8762 | |
| Kaiser Permanente-Oakland | |
| Oakland, California, United States, 94611 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Lucile Packard Children's Hospital Stanford University | |
| Palo Alto, California, United States, 94304 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123 | |
| UCSF Medical Center-Parnassus | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Children's Hospital Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale University | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Delaware | |
| Alfred I duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Nemours Children's Clinic-Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803 | |
| Nemours Children's Clinic - Orlando | |
| Orlando, Florida, United States, 32806 | |
| UF Cancer Center at Orlando Health | |
| Orlando, Florida, United States, 32806 | |
| Nemours Children's Clinic - Pensacola | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| Saint Petersburg, Florida, United States, 33701 | |
| Saint Joseph's Hospital/Children's Hospital-Tampa | |
| Tampa, Florida, United States, 33607 | |
| Saint Mary's Hospital | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Children's Healthcare of Atlanta - Egleston | |
| Atlanta, Georgia, United States, 30322 | |
| Memorial University Medical Center | |
| Savannah, Georgia, United States, 31404 | |
| United States, Hawaii | |
| University of Hawaii Cancer Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Saint Luke's Mountain States Tumor Institute | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Lurie Children's Hospital-Chicago | |
| Chicago, Illinois, United States, 60611 | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Advocate Children's Hospital-Oak Lawn | |
| Oak Lawn, Illinois, United States, 60453 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Indiana | |
| Indiana University/Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| Saint Vincent Hospital and Health Care Center | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| University of Kentucky/Markey Cancer Center | |
| Lexington, Kentucky, United States, 40536 | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| Johns Hopkins University/Sidney Kimmel Cancer Center | |
| Baltimore, Maryland, United States, 21287 | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889-5600 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Michigan State University Clinical Center | |
| East Lansing, Michigan, United States, 48824-7016 | |
| Helen DeVos Children's Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Kalamazoo Center for Medical Studies | |
| Kalamazoo, Michigan, United States, 49008 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| University of Missouri - Ellis Fischel | |
| Columbia, Missouri, United States, 65212 | |
| The Childrens Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Children's Hospital and Medical Center of Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Nevada Cancer Research Foundation CCOP | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Saint Joseph's Regional Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07902 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | |
| New York, New York, United States, 10016 | |
| Columbia University/Herbert Irving Cancer Center | |
| New York, New York, United States, 10032 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10065 | |
| State University of New York Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Carolinas Medical Center/Levine Cancer Institute | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, North Dakota | |
| Sanford Medical Center-Fargo | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Rainbow Babies and Childrens Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| Dayton Children's Hospital | |
| Dayton, Ohio, United States, 45404 | |
| The Toledo Hospital/Toledo Children's Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Mercy Children's Hospital | |
| Toledo, Ohio, United States, 43608 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center | |
| Portland, Oregon, United States, 97227 | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Penn State Hershey Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| East Tennessee Childrens Hospital | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| Texas Tech University Health Science Center-Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| UT Southwestern/Simmons Cancer Center-Dallas | |
| Dallas, Texas, United States, 75390 | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Primary Children's Hospital | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Virginia | |
| Childrens Hospital-King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Providence Sacred Heart Medical Center and Children's Hospital | |
| Spokane, Washington, United States, 99204 | |
| United States, West Virginia | |
| West Virginia University Charleston | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Saint Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, Queensland | |
| Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Royal Children's Hospital-Brisbane | |
| Herston, Queensland, Australia, 4029 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6008 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Chedoke Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8S 4L8 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| The Montreal Children's Hospital of the MUHC | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Centre Hospitalier Universitaire Sainte-Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec, Canada, G1V 4G2 | |
| New Zealand | |
| Starship Children's Hospital | |
| Grafton, Auckland, New Zealand, 1145 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8011 | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| San Juan, Puerto Rico, 00912 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | William Slayton | Children's Oncology Group |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00720109 History of Changes |
| Other Study ID Numbers: |
NCI-2009-00312 NCI-2009-00312 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000600217 COG-AALL0622 AALL0622 AALL0622 ( Other Identifier: Childrens Oncology Group ) AALL0622 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 22, 2008 Key Record Dates |
| Results First Posted: | October 7, 2016 |
| Last Update Posted: | October 7, 2016 |
| Last Verified: | September 2016 |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone acetate Methylprednisolone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Cortisone acetate |
Dexamethasone acetate Dexamethasone Prednisone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Hydrocortisone Cortisone Prednisolone hemisuccinate Prednisolone phosphate Isophosphamide mustard Pegaspargase Etoposide phosphate Cyclophosphamide Methotrexate |