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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131053
First Posted: August 17, 2005
Last Update Posted: November 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Japan Adult Leukemia Study Group
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Study Chair: Tomoki Naoe, MD Nagoya University
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00131053     History of Changes
Other Study ID Numbers: JALSG ALL202-U
First Submitted: August 15, 2005
First Posted: August 17, 2005
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Japan Adult Leukemia Study Group:
acute lymphoblastic leukemia
newly diagnosed
BCR-ABL-negative

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Dexamethasone
Prednisolone
Hydrocortisone
Pirarubicin
Cyclophosphamide
Methotrexate
Cytarabine
Vincristine
Asparaginase
6-Mercaptopurine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones