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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Japan Adult Leukemia Study Group.
Recruitment status was:  Recruiting
Information provided by:
Japan Adult Leukemia Study Group Identifier:
First received: August 15, 2005
Last updated: November 13, 2008
Last verified: November 2008
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • The rate of complete remission [ Time Frame: 3 years ]

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
Experimental: A 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.

Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00131053

Contact: Fumihiko Hayakawa, MD

Department of Hematology, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Japan, 466-8550
Contact: Fumihiko Hayakawa, MD   
Principal Investigator: Fumihiko Hayakawa, MD         
Sponsors and Collaborators
Japan Adult Leukemia Study Group
Study Director: Fumihiko Hayakawa, MD Nagoya University
Study Chair: Tomoki Naoe, MD Nagoya University
  More Information

Additional Information: Identifier: NCT00131053     History of Changes
Other Study ID Numbers: JALSG ALL202-U
Study First Received: August 15, 2005
Last Updated: November 13, 2008

Keywords provided by Japan Adult Leukemia Study Group:
acute lymphoblastic leukemia
newly diagnosed

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones processed this record on May 25, 2017