Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130195
• Other study ID #: JALSG Ph+ALL202
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2005
• Last updated: November 13, 2008
• Start date: September 2002
• Est. completion date: May 2008

Study information

• Verified date: November 2008
• Source: Japan Adult Leukemia Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Description:

Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 64 Years

Eligibility

Inclusion Criteria:

• Previously untreated BCR-ABL-positive ALL

• Age between 15 and 64 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• imatinib

• cyclophosphamide

• daunorubicin

• vincristine

• prednisolone

• methotrexate

• cytarabine

• dexamethasone

Locations

Country	Name	City	State
Japan	Department of Hematology, Nagoya University Graduate School of Medicine	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Japan Adult Leukemia Study Group

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Towatari M, Yanada M, Usui N, Takeuchi J, Sugiura I, Takeuchi M, Yagasaki F, Kawai Y, Miyawaki S, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Combination of intensive chemotherapy and imatinib can rapidly induce high-qu — View Citation

Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Kobayashi T, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Emi N, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. High complete remission rate and prom — View Citation

Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Nishii K, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Narimatsu H, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Karyotype at diagnosis is the majo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of complete remission		63 days	No
Secondary	The duration of remission		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Toxicity caused by combination of imatinib and chemotherapy		2 years	Yes

External Links

•   The JALSG homepage