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Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients 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 Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients Clinical research trials and Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients 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 Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients 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 Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients clinical trial. Test subjects typically obtain the finest healthcare available for their Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients 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 > "P" Clinical Trials Conditions > Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients  Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
For Condition: Leukemia, Myeloid
Status: Recruiting
Sponsor(s): ILEX Products ,
Synopsis: The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)
Details: This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute myelogenous leukemia (AML). Eligible patients must be in first or subsequent relapse or be refractory. Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Must: - Have a diagnosis of AML according to FAB classification with greater than or equal to 25% blasts in the bone marrow. - Be less than or equal to 21 years old at time of initial diagnosis. - Not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study. - Patients with acute promyelocytic leukemia (M3) must have been treated with at least 2 regimens-a retinoic acid-containing regimen and an arsenic trioxide-containing regimen before being considered for this study. - Have a Karnofsky Performance Status (KPS) of greater than or equal to 70. - Provide signed, written informed consent from parent or guardian and assent from patients greater than or equal to 7 years old according to local IRB and institutional requirements. - Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: - Serum bilirubin less than or equal to 1.5 x ULN - AST and ALT less than or equal to 5 x ULN - Serum Creatinine less than 2 x ULN for age ULN= Institutional Upper Limit of Normal Exclusion Criteria - Received previous treatment with Clofarabine. - Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. - Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. - Have psychiatric disorders that would interfere with consent, study participation, or follow up. - Are receiving any other chemotherapy. Patients must have been off previous therapy for at least 2 weeks (with the exception of intrathecal therapy, which is allowed up to 24hrs prio to 1st dose of study drug) and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier, following consultation with the ILEX Medical Monitor, if there is evidence of disease relapse prior to that time. - Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Have symptomatic CNS involvement. - Febrile neutropenia at time of study entry. - Known or suspected fungal infection (ie. patients on parenteral antifungal therapy).
Total Enrollment: 40
Location and Contact Information:
Children's Hospital *Recruiting*
San Diego, California,
United States
Recruiting Mehrzad Milburn 858-966-8155
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 67198
United States
Recruiting Sheree Gilmore 402-559-8864
Children's Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Beth Killmeyer 412-692-7593
Children's Hospital *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Michele Toms 215-590-7727
Children's Hospital *Recruiting*
Orange County, California,
United States
Recruiting Laura Gates 714-516-4203
Texas Children's Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Rene Klenke 834-824-4570
University of Connecticut Health Center *Recruiting*
Hartford, Connecticut, 06106
United States
Recruiting Robin Arens 860-545-9614
Memorial Sloan-Kettering *Recruiting*
New York City, New York,
United States
Recruiting Elizabeth deKosko 212-639-8430
Arkansas Children's Hospital *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting Bryce Warren 501-364-4003
Children's Hospital *Recruiting*
Denver, Colorado,
United States
Recruiting Hazel Senz 303-864-5380
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee,
United States
Recruiting Liza Emanus 901-495-3688
Cook's Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Amy Rowell 682-885-1904
Children's Memorial Hospital *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Rebecca Kissane 773-883-6186
Children's Hospital *Recruiting*
St. Louis, Missouri,
United States
Recruiting Lisa Garrett 314-454-4625
Johns Hopkins Children's Center *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Tammy Scott 410-614-5990
Children's Hospital *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Colleen McCarthy 323-660-2450
Children's Medical Center *Recruiting*
Dallas, Texas,
United States
Recruiting Tanja Hoffman 214-456-2726
The University of Texas M.D. Anderson Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Marily Elopre 713-745-0774
Additional Information:
Study ID Numbers: CLO-222;
Study Start Date: May 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042354
Other Leukemia, Myeloid Studies:
1. Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
2. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
3. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
4. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
Related Studies:
Other Leukemia, Myeloid Clinical Trials
Other California Clinical Trials
Other Orange County Clinical Trials
Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
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