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Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL) 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 Lymphoblastic Leukemia (ALL) 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 Lymphoblastic Leukemia (ALL) Clinical research trials and Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL) 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 Lymphoblastic Leukemia (ALL). Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL) 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 Lymphoblastic Leukemia (ALL) clinical trial. Test subjects typically obtain the finest healthcare available for their Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL) 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 Lymphoblastic Leukemia (ALL)  Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
For Condition: Leukemia, Lymphoblastic, Acute
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 Lymphoblastic Leukemia (ALL.)
Details: This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL). Eligible patients must be in second 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 ALL 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 second 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. - Have a Karnofsky Performance Status (KPS) of >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. - Be able to comply with study procedures and follow-up examinations. - 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 had a recent (<30 days) history of fungal or serious bacterial infection or who are receiving therapeutic antibiotics. - 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 prior to 1st 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, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or pancreas. - Have symptomatic CNS involvement. - Febrile neutropenia at time of study entry. - Have received a hematologic stem cell transplant (HSCT) within the previous 3 months or have active GVHD (greater than or equal to Grade 2).
Total Enrollment: 60
Location and Contact Information:
Children's Memorial Hospital *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Rebecca Kissane 773-883-6186
The University of Texas M.D. Anderson Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Marily Elopre 713-745-0774
Children's Hospital *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Sandi Lindahl 303-837-2624
Children's Hospital *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Colleen McCarthy 323-660-2450
Children's Hospital *Recruiting*
San Diego, California,
United States
Recruiting Mehrzad Milburn 858-966-8155
Memorial Sloan-Kettering *Recruiting*
New York City, New York,
United States
Recruiting Elizabeth deKosko 212-639-8430
Johns Hopkins Children's Center *Recruiting*
Baltimore, Maryland,
United States
Recruiting Tammy Scott 410-614-5990
Children's Hospital *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Michele Toms 215-590-7727
Texas Children's Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Rene Klenke 834-824-4570
Cook's Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Amy Rowell 682-885-1904
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee,
United States
Recruiting Liza Emanus 901-495-3688
Children's Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Beth Killmeyer 412-692-7593
Children's Hospital *Recruiting*
St. Louis, Missouri,
United States
Recruiting Lisa Garrett 314-454-4625
Children's Hospital *Recruiting*
Orange County, California,
United States
Recruiting Laura Gates 714-516-4203
Additional Information:
Study ID Numbers: CLO-212;
Study Start Date: May 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042341
Other Leukemia, Lymphoblastic, Acute Studies:
1. Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Related Studies:
Other Leukemia, Lymphoblastic, Acute Clinical Trials
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Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
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