Leukemia Clinical Trial
Official title:
A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
Verified date | August 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes
necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop
cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and
chemotherapy may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in
treating patients who have newly diagnosed chronic myeloid leukemia.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Newly diagnosed chronic myeloid leukemia in first chronic phase (within the past 6 months) - Philadelphia-chromosome positive OR - bcr-abl rearrangement - No prior treatment within the past 6 months other than hydroxyurea PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No hepatic dysfunction - Bilirubin less than 2 times normal - ALT less than 4 times normal Renal: - No renal dysfunction - Creatinine less than 2.3 mg/dL Cardiovascular: - No severe cardiac dysfunction - No New York Heart Association class II-IV heart disease Pulmonary: - No severe pulmonary disease Other: - HIV negative - No severe neurologic disease - No active uncontrolled infection - No other active malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent allogeneic transplantation with an HLA-A, B, DR-matched sibling donor or matched-unrelated donor Chemotherapy: - See Disease Characteristics Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - No concurrent grapefruit or grapefruit juice |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Sint-Jan | Brugge | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | U.Z. Gasthuisberg | Leuven | |
Belgium | Clinique Universitaire De Mont-Godinne | Mont-Godinne Yvoir | |
Netherlands | HagaZiekenhuis - Locatie Leyenburg | 's-Gravenhage | |
Netherlands | Meander Medisch Centrum | Amersfoort | |
Netherlands | Academisch Medisch Centrum at University of Amsterdam | Amsterdam | |
Netherlands | Vrije Universiteit Medisch Centrum | Amsterdam | |
Netherlands | Medisch Spectrum Twente | Enschede | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | |
Netherlands | Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | |
Netherlands | University Medical Center Utrecht | Utrecht | |
Netherlands | Isala Klinieken - locatie Sophia | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Commissie Voor Klinisch Toegepast Onderzoek |
Belgium, Netherlands,
Deenik W, Janssen JJ, van der Holt B, Verhoef GE, Smit WM, Kersten MJ, Daenen SM, Verdonck LF, Ferrant A, Schattenberg AV, Sonneveld P, van Marwijk Kooy M, Wittebol S, Willemze R, Wijermans PW, Beverloo HB, Löwenberg B, Valk PJ, Ossenkoppele GJ, Corneliss — View Citation
Deenik W, van der Holt B, Verhoef GE, Smit WM, Kersten MJ, Kluin-Nelemans HC, Verdonck LF, Ferrant A, Schattenberg AV, Janssen JJ, Sonneveld P, van Marwijk Kooy M, Wittebol S, Willemze R, Wijermans PW, Westveer PH, Beverloo HB, Valk P, Löwenberg B, Ossenk — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicity and treatment-related toxicity per dose level | Yes | ||
Secondary | Rate and duration of molecular response | No | ||
Secondary | Rate and duration of complete hematological response | No | ||
Secondary | Rate and duration of complete cytogenetic response | No | ||
Secondary | Time to treatment failure | No | ||
Secondary | Overall survival | No |
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