- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126893
Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
May 14, 2007 updated by: Celgene Corporation
Phase 1 Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
This is a single center Phase 1 study to evaluate the safety, pharmacokinetics and pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia.
Study Overview
Study Type
Interventional
Enrollment
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-5149
- Indiana University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Must be greater than or equal to 18 years of age at the time of signing the informed consent form.
Must have a diagnosis of high-risk myeloid leukemia, defined as:
- Subjects > 70 years of age with newly diagnosed acute myelogenous leukemia (AML) (regardless of karyotype) who decline conventional induction chemotherapy;
- Subjects > 60 years of age with newly diagnosed AML and poor-risk cytogenetics or a history of secondary AML who decline conventional induction chemotherapy;
- Subjects with newly diagnosed AML who do not experience a CR after at least 2 cycles of induction chemotherapy;
- Subjects with AML who do not experience a second or greater complete remission after 1 but no more than 2 cycles of re-induction chemotherapy;
- Subjects with recurrence of AML after a remission duration of less than three months in subjects < 60 years of age or remission duration of less than six months in subjects > 60 years of age; or
- Subjects with imatinib-refractory chronic myeloid leukemia (CML) in blast crisis defined as > 30% blasts and promyelocytes in the peripheral blood or bone marrow smear despite treatment with imatinib > 600 mg/daily
- ECOG performance status < 2 (see Appendix 2).
- Serum creatinine < 2 mg/d and ALT (SGPT), alkaline phosphatase, and conjugated bilirubin < 2 times the upper limit of normal.
- No conventional or investigational anti-leukemic treatment within two weeks of the administration of study drug with the exception of hydroxyurea to control the peripheral blood blast count.
- Subjects must have recovered from any prior treatment-related toxicities.
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
- Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication
Exclusion Criteria:
- Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging; individuals with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks prior to enrollment in the study.
- Subjects who are pregnant or lactating; women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days prior to the initial treatment with CC-401.
- Subjects with severe or life threatening active, unresolved systemic infections.
- Prior history of malignancy other than myeloid leukemia (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.
- Known HIV-1 positivity.
- Known hepatitis B surface antigen (HBsAg) positivity.
- Prior treatment with CC-401
- Use of any other experimental drug or treatment within 28 days of baseline
- Inability to provide a bone marrow aspirate
- Subjects with severe or life-threatening active bleeding refractory to platelet transfusion
- Subjects with severe or life-threatening anemia refractory to red blood cell transfusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
August 3, 2005
First Submitted That Met QC Criteria
August 3, 2005
First Posted (Estimate)
August 5, 2005
Study Record Updates
Last Update Posted (Estimate)
May 15, 2007
Last Update Submitted That Met QC Criteria
May 14, 2007
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC-401-AML-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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