|
Acute Myeloid Leukemia Study Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Acute Myeloid Leukemia Study conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Acute Myeloid Leukemia Study Clinical research trials and Acute Myeloid Leukemia Study medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Acute Myeloid Leukemia Study. Acute Myeloid Leukemia Study Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Acute Myeloid Leukemia Study clinical trial. Subjects often receive the most expert healthcare possible for their Acute Myeloid Leukemia Study condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Acute Myeloid Leukemia Study  Acute Myeloid Leukemia Study
Acute Myeloid Leukemia Study
For Condition: Acute Myeloid Leukemia
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study. Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study. Phase II will only allow enrollment of younger de novo AML. All patients must also fulfill the following criteria: - Age 18 years or older for relapsed or refractory patients if enrolled in Phase I. De novo patients must be greater than or equal to 18 years and less than 60 years. - Morphologic diagnosis of AML from bone marrow aspirate and biopsy. At the discretion of the attending physician, peripheral blood may substitute for a bone marrow aspirate and biopsy if the peripheral blood blast count is adequate to obtain diagnostic material. - Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33-positive, based on local laboratory criteria. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 inclusive. - Serum creatinine less than or equal to 2.0 mg/dL (177 μmol/L). - Serum total bilirubin less than or equal to 1.5 mg/dL (26 μmol/L). - Serum AST (SGOT) and ALT (SGPT) less than or equal to 5 x ULN (less than or equal to NCI grade 2, version 2 of the NCI Grade Toxicity Scale). - Capable of giving signed and dated informed consent. - Negative serum pregnancy test within 1 week prior to first treatment if the patient is a woman of childbearing potential. Male and female patients of childbearing potential must use a medically acceptable and effective method of contraception throughout the study. - Cardiac ejection fraction as determined by radionuclide scanning (measured in %) or echocardiography (measured as abnormal or normal) is within normal limits within 14 days of study Day 1. Exclusion Criteria: - AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration. - De novo patients with M3 AML. - AML secondary to exposure to chemotherapy or radiation. - Known central nervous system (CNS) involvement with AML. A lumbar puncture is not required unless CNS involvement with AML is clinically suspected. - Prior treatment with any type of HSCT for relapsed and refractory patients (including autologous, allogenic, and mini-allogeneic HSCT) if enrolled in Phase I. (Only de novo patients will be enrolled in Phase II.) - Pregnant women and nursing mothers. - Prior therapy with anti-CD33 antibodies. - Other active malignancy (with the exception of basal and squamous cell skin cancer) at the time of study entry. - Uncontrolled infections. - Severe pulmonary or cardiac disease. - Known to be HIV positive - Investigational agent within 4 weeks of study start.
Total Enrollment:
Location and Contact Information:
New York Medical College *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Delong Liu 914-594-4383
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting James Foran 402-559-4810
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Philip Amrein 617-726-8748
Department of Clinical Haematology - University College Hospital *Recruiting*
London, , WC1E 6AU
United Kingdom
Recruiting Anthony Goldstone 1713876424
Dana Farber Cancer Institute - Dept. of Oncology *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Daniel Angelo 617-632-2214
Policlinico Universitario - Divisione di Ematologia *Recruiting*
Udine, , 33100
Italy
Recruiting Domenico Russo -560055
Hospital Dijkzigt *Recruiting*
Rotterdam, , 3015 GD
Netherlands
Recruiting Bob Lowenberg 104659222
University of Miami - Division of Hematology/Oncology *Recruiting*
Miami, Florida, 33136
United States
Recruiting Hugo Fernandez 305-243-9115
University Hospital of Wales *Recruiting*
Cardiff, , CF4 4XW
United Kingdom
Recruiting Alan Burnett +44 (0) 29 20 747747
Northwestern  School  Of  Medicine *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Martin Tallman 312-503-1366
Westmead Hospital *Recruiting*
Westmead, , 2145
Australia
Recruiting Ken Bradstock 61 2 98457073
Hospital Clinic i Provincial *Recruiting*
Barcelona, , 8036
Spain
Recruiting Jordi Esteve 932275423
Additional Information:
Study ID Numbers: 0903B1-206-US;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037583
Other Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
2. An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome
3. Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML
4. Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults with Acute Myeloid Leukemia
5. Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Related Studies:
Other Acute Myeloid Leukemia Clinical Trials
Other Clinical Trials
Other Barcelona Clinical Trials
Acute Myeloid Leukemia Study
|
|
|
|
|
|
|
|
