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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00720109
First received: July 19, 2008
Last updated: September 8, 2016
Last verified: September 2016
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) |
Resource links provided by NLM:
Drug Information available for:
Dasatinib
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
Lymphosarcoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
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.
| Enrollment: | 63 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2015 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (enzyme inhibitor therapy and chemotherapy)
See Detailed Description
|
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
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
-
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
-
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
-
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00720109
Show 127 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720109
Show 127 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | William Slayton | Children's Oncology Group |
More Information
| 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 ) |
| Study First Received: | July 19, 2008 |
| Results First Received: | September 8, 2016 |
| Last Updated: | September 8, 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 Cortisol succinate Hydrocortisone acetate Cortisone acetate |
Dexamethasone acetate Dexamethasone Prednisone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Hydrocortisone Cortisone Prednisolone hemisuccinate Prednisolone phosphate Isophosphamide mustard Pegaspargase Etoposide phosphate Cyclophosphamide Methotrexate |
ClinicalTrials.gov processed this record on July 24, 2017