|
Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation Clinical research trials and Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation clinical trial. Test subjects typically receive the most expert healthcare available for their Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation  Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
For Condition: Acute Myelogenous Leukemia
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.
Details:
Eligibility:
Study Type: Interventional, Open Label
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria. Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment. - The patient must be greater than or equal to 60 days post-HCST. - Patients of all ages may be entered in this study. - A negative serum pregnancy test at screening for post-menarchal females of childbearing potential. - ECOG performance status 0-2 - Serum creatinine less than or equal to 2.5 mg/dL. - Serum total bilirubin less than or equal to 2.0 mg/dL. Exclusion Criteria - Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration. - Known active central nervous system (CNS) or testicular leukemia at time of study entry. - Prior therapy with anti-CD33 antibodies. - Other active malignancy at time of study entry. - Uncontrolled infections. - Known to be HIV positive. - Cardiac ejection fraction < 30% or cardiac failure requiring therapy. - Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen. - History of clinical veno-occlusive disease of the liver as manifested by a > 5% increase in weight over baseline and any total serum bilirubin > 5 mg/dL within the first 20 days post transplant. - Investigational / conventional antileukemic agent within 4 weeks of study start. - Pregnant women or nursing mothers.
Total Enrollment:
Location and Contact Information:
Research Site *Recruiting*
Canton, Ohio, 44708
United States
Recruiting
Research Site *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
Research Site *Recruiting*
Olathe, Kansas, 66061
United States
Recruiting
Research Site *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Research Site *Recruiting*
Buffalo, New York, 14215
United States
Recruiting
Research Site *Recruiting*
Hartford, Connecticut, 06102
United States
Recruiting
Research Site *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting
Research Site *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting
Research Site *Recruiting*
Charleston, West Virginia, 25304
United States
Recruiting
Research Site *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting
Research Site *Recruiting*
Trenton, New Jersey, 08629
United States
Recruiting
Research Site *Recruiting*
Little Rock, Arkansas, 72211
United States
Recruiting
Research Site *Recruiting*
Rochester, New York, 14642
United States
Recruiting
Additional Information:
Study ID Numbers: 0903X-100374;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044733
Other Acute Myelogenous Leukemia Studies:
1. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
2. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
3. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
4. A Phase I Study of DT388GMCSF Fusion Protein in AML and CMML
5. Study of Gelonin Purging of Autologous Stem Cells for Transplantation
Related Studies:
Other Acute Myelogenous Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
|
|
|
|
|
|
|
|
