Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)

NCT00131053 | Unknown Phase 2 DMC

• 1 other identifier: JALSG ALL202-U
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoblastic Leukemia, Acute

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  3 years

Secondary Outcomes (1)

• The rate of complete remission

  3 years

Study Arms (1)

A

EXPERIMENTAL

Drug: Methotrexate; Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Pirarubicin; Drug: Cyclophosphamide; Drug: L-asparaginase; Drug: Cytarabine; Drug: Hydrocortisone; Drug: Mercaptopurine

Interventions

Methotrexate DRUG

A

Prednisolone DRUG

A

Dexamethasone DRUG

A

Vincristine DRUG

A

Pirarubicin DRUG

A

Cyclophosphamide DRUG

A

L-asparaginase DRUG

A

Cytarabine DRUG

A

Hydrocortisone DRUG

A

Mercaptopurine DRUG

A

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Adult Leukemia Study Group: lead

Study Sites (1)

Department of Hematology, Nagoya University Graduate School of Medicine

Nagoya, 466-8550, Japan

RECRUITING

Related Links

• The JALSG homepage

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Methotrexate; Prednisolone; Dexamethasone; Vincristine; pirarubicin; Cyclophosphamide; Asparaginase; Cytarabine; Hydrocortisone; Mercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sulfhydryl Compounds; Sulfur Compounds; Purines

Study Officials

• Fumihiko Hayakawa, MD

  Nagoya University

  STUDY DIRECTOR

• Tomoki Naoe, MD

  Nagoya University

  STUDY CHAIR

Central Study Contacts

Fumihiko Hayakawa, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 17, 2005
• Study Start: September 1, 2002
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 14, 2008

Record last verified: 2008-11

Locations

JP (1)