Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL) - Full Text View

Sponsored by:	Japan Adult Leukemia Study Group
Information provided by:	Japan Adult Leukemia Study Group
ClinicalTrials.gov Identifier:	NCT00131053

Purpose

The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.

Condition	Intervention	Phase
Lymphoblastic Leukemia, Acute	Drug: Methotrexate Drug: Prednisolone Drug: Dexamethasone Drug: Vincristine Drug: Pirarubicin Drug: Cyclophosphamide Drug: L-asparaginase Drug: Cytarabine Drug: Hydrocortisone Drug: Mercaptopurine	Phase II

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

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Methotrexate Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Vincristine sulfate Vincristine Pirarubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia

Further study details as provided by Japan Adult Leukemia Study Group:

Primary Outcome Measures:

Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of complete remission [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Methotrexate Drug: Prednisolone Drug: Dexamethasone Drug: Vincristine Drug: Pirarubicin Drug: Cyclophosphamide Drug: L-asparaginase Drug: Cytarabine Drug: Hydrocortisone Drug: Mercaptopurine

Detailed Description:

The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.

Eligibility

Ages Eligible for Study:	15 Years to 24 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated BCR-ABL-negative ALL
Age between 15 and 24 years
Performance status between 0 and 3 (ECOG criteria)
Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL); kidneys (serum creatinine level < 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
Written informed consent to participate in the trial

Exclusion Criteria:

Uncontrolled active infection
Another severe and/or life-threatening disease
Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
Another primary malignancy which is clinically active and/or requires medical interventions
Pregnant and/or lactating women
Past history of renal failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131053

Contacts

Contact: Fumihiko Hayakawa, MD

bun-hy@med.nagoya-u.ac.jp

Locations

Japan
Department of Hematology, Nagoya University Graduate School of Medicine	Recruiting
Nagoya, Japan, 466-8550
Contact: Fumihiko Hayakawa, MD bun-hy@med.nagoya-u.ac.jp
Principal Investigator: Fumihiko Hayakawa, MD

Sponsors and Collaborators

Japan Adult Leukemia Study Group

Investigators

Study Director:	Fumihiko Hayakawa, MD	Nagoya University Graduate School of Medicine
Study Chair:	Tomoki Naoe, MD	Nagoya University Graduate School of Medicine

More Information

The JALSG homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	JALSG ALL202-U
Study First Received:	August 15, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00131053
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Adult Leukemia Study Group:

acute lymphoblastic leukemia
newly diagnosed
BCR-ABL-negative
Acute lymphoblastic leukemia

Study placed in the following topic categories:

Dexamethasone
Leukemia, Lymphoid
Hydrocortisone
Methylprednisolone
Prednisolone acetate
Cyclophosphamide
6-Mercaptopurine
Leukemia
Methotrexate
Lymphoma
Dexamethasone acetate
Cytarabine
Methylprednisolone Hemisuccinate

Pirarubicin
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Cortisol succinate
Methylprednisolone acetate
Vincristine
Folic Acid
Lymphatic Diseases
Prednisolone
Hydrocortisone acetate
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents

Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009