Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00720109

Purpose

RATIONALE: 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.

PURPOSE: This phase II 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.

Condition	Intervention	Phase
Leukemia	Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: dasatinib Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Dexamethasone Hydrocortisone acetate Cyclophosphamide Hydrocortisone 6-Mercaptopurine Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Citrovorum factor Dexamethasone acetate Doxiproct plus Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Methylprednisolone Pegaspargase Dasatinib Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Cortisol succinate Ifosfamide Cortisol 21-phosphate Folinic acid calcium salt pentahydrate Mercaptopurine L-Asparaginase

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility as assessed by examining the adverse events, delays in administering combination therapy, minimal residual disease (MRD) levels at the completion of induction therapy and consolidation therapy, and event-free survival (EFS) [ Designated as safety issue: Yes ]
Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
3-year event-free survival (EFS) of patients with standard-risk disease treated with dasatinib in combination with intensified chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the end-of-induction minimal residual disease (MRD) levels in patients treated with dasatinib on this study with the end-of-induction MRD levels in patients treated on clinical trial COG-AALL0031 [ Designated as safety issue: No ]
Comparison of the end-of-consolidation MRD levels in patients treated with dasatinib on this study with the end-of-consolidation MRD levels in patients treated with imatinib mesylate during blocks 1 and 2 consolidation therapy (cohorts 3-5) on COG- ... [ Designated as safety issue: No ]
Overall 3-year EFS rate for both standard- and high-risk patients [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	July 2008
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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
Concurrent enrollment on COG-AALL03B1 (or a successor trial) AND a front-line COG ALL clinical trial (e.g., COG-AALL0232, COG-AALL0331, COG-AALL0434 or other front-line COG ALL clinical trial) required
- Received the first 2 weeks of induction therapy (days 1-14) as specified in the front-line COG ALL clinical trial
  - Patients may NOT have received day 15 of induction therapy on the front-line COG ALL clinical trial prior to enrollment on this study
No Down syndrome

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
Lansky PS 50-100% (for patients ≤ 16 years of age)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min 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)
ALT < 2.5 times ULN
Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by gated radionuclide study
QTc ≤ 0.45 seconds by EKG
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No evidence of dyspnea at rest
No exercise intolerance
Pulse oximetry > 94% at sea level (if there is a clinical indication for determination)
Seizure disorder allowed provided it is well controlled on anticonvulsants

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No other concurrent cancer chemotherapy or immunomodulatory agents (including steroids)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720109

Show 85 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

William B. Slayton, MD

University of Florida

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000600217, COG-AALL0622
Study First Received:	July 19, 2008
Last Updated:	September 5, 2009
ClinicalTrials.gov Identifier:	NCT00720109 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
Philadelphia chromosome positive childhood precursor acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Philadelphia Chromosome
Prednisone
Anti-Infective Agents
Hydrocortisone
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Tyrosine
Antiemetics
6-Mercaptopurine
Protein Kinase Inhibitors
Hormones
Pegaspargase

Dasatinib
Methotrexate
Etoposide
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
Glucocorticoids
Folic Acid
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Acute Lymphoblastic Leukemia, Childhood
Antimetabolites

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Philadelphia Chromosome
Anti-Infective Agents
Prednisone
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Protein Kinase Inhibitors
Hormones

Pegaspargase
Pathologic Processes
Dasatinib
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Vincristine

ClinicalTrials.gov processed this record on September 09, 2009