Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
This study has been terminated.
Information provided by:
First received: August 3, 2005
Last updated: May 14, 2007
Last verified: December 2006
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 1 Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126893
|Indiana University Medical Center
|Indianapolis, Indiana, United States, 46202-5149 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 3, 2005
||May 14, 2007
||United States: Food and Drug Administration
Keywords provided by Celgene Corporation:
High Risk Myeloid Leukemia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Neoplasms by Histologic Type