Overview

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

Status:
Completed

Trial end date:
2020-04-16

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fox Chase Cancer Center
Temple University

Collaborators:

M.D. Anderson Cancer Center
TEVA
Teva Pharmaceuticals USA

Treatments:

Arsenic Trioxide
Azacitidine
Carboplatin
Decitabine

Criteria

Inclusion Criteria:

1. 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.

2. Performance 0-2 (ECOG).

3. Adequate cardiac functions assessed by 2D ECHO (NYHA cardiac III-IV excluded).

4. Pre-treatment EKG

5. Adequate end organ function with creatinine AST and ALT
6. Absence of significant intercurrent illness such as uncontrolled heart failure,
unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving
of informed consent.

7. Signed informed consent

Exclusion Criteria:

1. 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.

2. Current uncontrolled infections.

3. 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.

4. Chronic kidney disease > stage 3.

5. HIV infection.