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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 15, 2005

Last Updated Date

November 13, 2008

Start Date ^†

September 2002

Current Primary Outcome Measures ^†

Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00131053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

The rate of complete remission [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Toxicity
The rate of complete remission

Descriptive Information

Brief Title ^†

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

Official Title ^†

Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Lymphoblastic Leukemia, Acute

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

120

Estimated Completion Date

September 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

15 Years to 24 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Fumihiko Hayakawa, MD

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

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00131053

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Japan Adult Leukemia Study Group

Collaborators ^††

Investigators ^†

Study Director:	Fumihiko Hayakawa, MD	Nagoya University Graduate School of Medicine
Study Chair:	Tomoki Naoe, MD	Nagoya University Graduate School of Medicine

Information Provided By

Japan Adult Leukemia Study Group

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.