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Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome Clinical research trials and Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome clinical trial. Human subjects often get the best healthcare possible for their Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome  Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
For Condition: untreated adult acute myeloid leukemia,refractory anemia with excess blasts in transformation,de novo myelodysplastic syndromes,secondary myelodysplastic syndromes,refractory anemia with excess blasts,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining idarubicin and cytarabine with gemtuzumab ozogamicin in treating patients who have previously untreated high-riskmyelodysplastic syndrome or acute myeloid leukemiasecondary to myelodysplastic syndrome.
Details: OBJECTIVES: Primary - Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine in patients with previously untreated high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia secondary to MDS. - Determine the toxicity profile of this regimen in these patients. - Determine the antileukemic/anti-MDS activity of this regimen in these patients. Secondary - Determine the hepatotoxicity of this regimen, in terms of veno-occlusive disease, in these patients. - Determine the severity of pancytopenia and duration of recovery in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive remission-induction comprising idarubicin IV over 5 minutes on days 1, 3, and 5; cytarabine IV continuously over 24 hours on days 1-10; and gemtuzumab ozogamicin IV over 2 hours on day 7. Treatment continues for a second course in the absence of unacceptable toxicity. Patients achieving complete remission are recommended for consolidation therapy off study. Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of 1 of the following: - High-risk myelodysplastic syndromes (MDS), including any of the following: - Refractory anemia with excess blasts (RAEB) with > 10% blast cells in the bone marrow - RAEB in transformation - Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count < 500/mm^3 and/or platelet count < 20,000/mm^3 - Chronic myelomonocytic leukemia with > 5% blast cells in the bone marrow - Chronic myelomonocytic leukemia with neutrophil count > 16,000/mm^3 OR monocyte count > 2,600/mm^3 - Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration - No identified HLA-identical sibling - No active CNS leukemia PATIENT CHARACTERISTICS: Age - 16 to 70 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) Renal - Creatinine 1.5 times ULN Cardiovascular - No severe cardiovascular disease - No arrhythmias requiring chronic treatment - No congestive heart failure - No symptomatic ischemic heart disease Pulmonary - No severe lung disease Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other concurrent malignant disease - No active uncontrolled infection - No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year) - No concurrent severe neurological or psychiatric disease - No other psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - More than 6 weeks since prior growth factors Chemotherapy - No prior intensive chemotherapy - More than 6 weeks since prior low-dose chemotherapy or hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 6 weeks since prior immunosuppressants - No prior participation in this clinical study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TheoWitte, , University Medical Center Nijmegen
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
A.Z. St. Jan *Recruiting*
Brugge, , 8000
Belgium
Recruiting Contact Person 32-50-45-2800
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Additional Information:
Study ID Numbers: CDR0000349501; EORTC-06013
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077116
Other Secondary Myelodysplastic Syndromes Studies:
1. Infliximab in Treating Patients With Myelodysplastic Syndrome
2. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
3. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
4. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
5. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
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Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
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