Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia

In brief

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 MDS but are not usually combined together. The investigators are looking at both the safety and Efficacy of each combination.

Key facts

Study ID

NCT02190695

Run by

Fox Chase Cancer Center

People needed

92

Starts

2013-04-01

Expected to finish

2020-04-16

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Temple BMT Program at Jeanes Hospital — Philadelphia, Pennsylvania, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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