High-Dose Methotrexate (MTX) for Adult 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:	NCT00131027

Purpose

The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

Condition	Intervention	Phase
Lymphoblastic Leukemia, Acute	Drug: Cyclophosphamide Drug: Daunorubicin Drug: Vincristine Drug: Prednisolone Drug: L-asparaginase Drug: Cytarabine Drug: Etoposide Drug: Dexamethasone Drug: Methotrexate Drug: Mercaptopurine Drug: Doxorubicin	Phase III

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

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus 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 Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults

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:

Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
The rate of complete remission [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	September 2002
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental HD-MTX	Drug: Cyclophosphamide Drug: Daunorubicin Drug: Vincristine Drug: Prednisolone Drug: L-asparaginase Drug: Cytarabine Drug: Etoposide Drug: Dexamethasone Drug: Methotrexate 3 g/sqm (high dose) Drug: Mercaptopurine Drug: Doxorubicin
B: Active Comparator ID-MTX	Drug: Cyclophosphamide Drug: Daunorubicin Drug: Vincristine Drug: Prednisolone Drug: L-asparaginase Drug: Cytarabine Drug: Etoposide Drug: Dexamethasone Drug: Mercaptopurine Drug: Doxorubicin Drug: Methotrexate 0.5 g/sqm (intermediate dose)

Detailed Description:

Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.

Eligibility

Ages Eligible for Study:	25 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated BCR-ABL-negative ALL
Age between 25 and 64 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: NCT00131027

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-O
Study First Received:	August 15, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00131027
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
Daunorubicin
Leukemia, Lymphoid
Methylprednisolone
Prednisolone acetate
Cyclophosphamide
6-Mercaptopurine
Etoposide phosphate
Acute lymphoblastic leukemia, adult
Leukemia
Methotrexate
Lymphoma
Etoposide

Dexamethasone acetate
Cytarabine
Methylprednisolone Hemisuccinate
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Methylprednisolone acetate
Vincristine
Doxorubicin
Folic Acid
Lymphatic Diseases
Prednisolone
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
Antibiotics, Antineoplastic
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

ClinicalTrials.gov processed this record on January 16, 2009