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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | December 13, 2008 | ||||
| Start Date ICMJE | December 1998 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003694 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase | ||||
| Official Title ICMJE | A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC# 141633) and Low-Dose Cytarabine | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. |
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| Detailed Description | OBJECTIVES: I. Assess the hematologic and cytogenetic response rate of newly diagnosed patients with chronic myelogenous leukemia treated with homoharringtonine and low dose cytarabine. II. Assess the toxicity of this combination regimen in these patients. OUTLINE: Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon. Patients are followed every 6 months for 10 years. PROJECTED ACCRUAL: This study will accrue up to 60 patients in 1.5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Stone RM, Donohue KA, Stock W, Hars V, Linker CA, Shea T, Deangelo DJ, Marcucci G, Bloomfield CD, Larson RA; for the Cancer and Leukemia Group B. A phase II study of continuous infusion homoharringtonine and cytarabine in newly diagnosed patients with chronic myeloid leukemia: CALGB study 19804. Cancer Chemother Pharmacol. 2008 Aug 1; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed chronic myelogenous leukemia in chronic phase Must meet one or more of the following criteria: Cytogenetically determined Philadelphia chromosome (Ph+) BCR/ABL protein detectable by immunoblotting Polymerase chain reaction positive fusion transcripts for BCR/ABL BCR/ABL translocation present by fluorescence in situ hybridization Must be ineligible for early allogeneic bone marrow transplant Must be registered on companion protocols CALGB-9665 and CALGB-29801 PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon therapy Chemotherapy: No more than 8 weeks of prior hydroxyurea therapy No prior homoharringtonine No prior busulfan or cytarabine for disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except for nondisease related conditions No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: No concurrent palliative radiotherapy for splenomegaly Surgery: No concurrent surgical splenectomy except in emergency situation |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003694 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066797, CLB-19804 | ||||
| Study Sponsor ICMJE | Cancer and Leukemia Group B | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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