Status:
COMPLETED
Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
M.D. Anderson Cancer Center
Teva Pharmaceuticals USA
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and...
Detailed Description
Study Groups: If the participant is found to be eligible to take part in this study and he/she is one of the first 30 participants enrolled, the participant will have an equal chance of being in one ...
Eligibility Criteria
Inclusion
- Patients with AML, relapsed or refractory to standard therapy or elderly patients with AML (age 65 or over). Patients who have AML and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. Patients with de novo or treated MDS or CMML INT-1 or above are eligible. Patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; A caveat to this is in the case of rapidly progressive disease. Hydroxyurea is permitted for control of elevated WBC prior to treatment and can be continued for the first 4 weeks of therapy. Erythropoiesis stimulating agents (ESAs) and GCSF are allowed before therapy. ESAs, GCSF or other growth factors are permitted on therapy.
- Performance 0-2 (ECOG).
- Adequate cardiac functions assessed by 2D ECHO (NYHA cardiac III-IV excluded).
- Pre-treatment EKG
- Adequate end organ function with creatinine \</= 2mg/dL and total bilirubin \</= 2mg/dL, AST and ALT \</= or = 2.5 X institutional ULN.
- Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
- Signed informed consent
Exclusion
- Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become preg-nant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Current uncontrolled infections.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Chronic kidney disease \> stage 3.
- HIV infection.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT02190695
Start Date
April 1 2013
End Date
April 16 2020
Last Update
May 19 2021
Active Locations (2)
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1
Temple BMT Program at Jeanes Hospital
Philadelphia, Pennsylvania, United States, 19111
2
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030