Status:
UNKNOWN
My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
Lead Sponsor:
University of Bologna
Conditions:
Lymphoid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal o...
Eligibility Criteria
Inclusion
- Diagnosis of ALL (any type included), in patients who:
- have relapsed after conventional chemotherapy\* or,
- are refractory to at least 1 cycle of chemotherapy\*
- ECOG Performance score of 0-3
- Adequate hepatic and renal function, as defined by serum transaminases \<2.5x ULN, bilirubin \<1.5xULN, and creatinine \<1.5x ULN.
- Age 18 years or greater.
- Documentation of written informed consent to participate in the trial.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
- either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
Exclusion
- Treatment with any investigational agent within 3 weeks prior to study therapy.
- Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
- Presence of central nervous system (CNS) leukemia.
- Active uncontrolled bacterial infection.
- Known human immunodeficiency virus (HIV) infection.
- Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
- Pregnancy or breast-feeding.
- Malabsorption syndromes
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00801580
Start Date
March 1 2008
End Date
September 1 2010
Last Update
September 15 2009
Active Locations (1)
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1
Institute of Hematology "L. & A. Seragnoli"
Bologna, Italy, 40138