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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Japan Adult Leukemia Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Japan Adult Leukemia Study Group
ClinicalTrials.gov Identifier:
NCT00131053
First received: August 15, 2005
Last updated: November 13, 2008
Last verified: November 2008
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Pirarubicin
Asparaginase
Dexamethasone
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
BB 1101
Dexamethasone acetate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone

ClinicalTrials.gov processed this record on August 01, 2014