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Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical research trials and Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome clinical trial. Test subjects typically obtain the finest healthcare available for their Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome  Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
For Condition: untreated adult acute myeloid leukemia,de novo myelodysplastic syndrome,refractory anemia with excess blasts in transformation,refractory anemia with excess blasts,Neutropenia,accelerated phase chronic myelogenous leukemia,Chronic Myelomonocytic Leukemia,blastic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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 high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease. PROTOCOL OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival. PROJECTED ACCRUAL: 60 patients will be entered over 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia - Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia - Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy; RAEB in transformation; Chronic myelomonocytic leukemia - No acute promyelocytic leukemia --Prior/Concurrent Therapy-- - No prior therapy except biologic agent alone or hydroxyurea --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL; Transaminases no greater than 3 times normal - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure - Other: No concurrent active malignancy; No pregnant or nursing women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterMaslak, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000064897; MSKCC-96044,NCI-V96-0941
Study Start Date: July 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002800
Other De Novo Myelodysplastic Syndrome Studies:
1. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
2. FR901228 in Treating Patients With Hematologic Cancer
3. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
4. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
5. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Related Studies:
Other de novo myelodysplastic syndrome Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
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