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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Teva Pharmaceuticals USA | INDUSTRY |
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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.
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 of 3 study groups. If the participant enrolls after the first 30 participants are enrolled, he/she will have a higher chance of being assigned to the group is having better results.
Study Drug Administration:
Every 4 weeks is a study cycle.
The participant will receive decitabine by vein over about 1 hours on Days 1-5 of each cycle.
If the participant is receiving carboplatin, he/she will receive it over 1 hour on Day 8 (+/-2 days) of each cycle.
If the participant is receiving arsenic trioxide, he/she will receive it over about 1 hour on Days 1-5 of each cycle
Study Visits:
Blood (about 1-2 teaspoons) will be drawn 1-2 times a week during Cycle 1 and then every 2-4 weeks after that for routine tests. If you have stable disease, blood will only be drawn every 4-6 weeks.
On Day 28 of Cycle 3 (+/- 3 days), the participant will have a bone marrow aspirate and biopsy to check the status of the disease. After that, the participant will have bone marrow biopsies/aspirations when the doctor thinks it is needed.
If the participant is in Group 3, he/she will have EKGs on Day 1 of each cycle before receiving the study drugs. On Days 1 and 4 of each cycle, blood (about 1-2 teaspoons) will also be drawn for routine tests before their dose of the study drugs.
If the participant is taken off study, blood (about 1-2 teaspoons) will be drawn for routine tests.
Length of Study:
The participant may continue taking the study drugs for as long as the doctor thinks it is in your best interest. The participant will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if he/she is unable to follow study directions.
This is an investigational study. Arsenic trioxide is FDA approved and commercially available for the treatment of APL. Decitabine is FDA approved and commercially available for the treatment of MDS. Carboplatin is FDA approved and commercially available for the treatment solid tumors. The study drug or study drug combination the participant receives on this study are considered investigational.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine | Active Comparator | Decitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days |
|
| Decitabine and Carboplatin | Experimental | Decitabine 20mg/m2 IV over 1hour daily times 5 days, plus Carboplatin AUC 5 IV over 1hour on day 8. repeat every 28 days. |
|
| Decitabine and Arsenic | Experimental | Decitabine 20mg/m2 IV over 1 hour daily for 5 days plus Arsenic Trioxide 0.15mg/kg IV daily for 5 days. repeat every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | 20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete or partial remission | evaluation of the complete and partial response rates (antileukemic effect) and the amount of time taken to achieve the response. | up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Kropf, MD | Temple University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple BMT Program at Jeanes Hospital | Philadelphia | Pennsylvania | 19111 | United States | ||
| M.D. Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40453133 | Derived | Kropf PL, Chung W, Shameem R, Xiao L, Balch C, Huang X, Issa JJ. A phase 2 study of decitabine with or without carboplatin and arsenic trioxide in patients with MDS and AML. Blood Neoplasia. 2025 Jan 23;2(2):100071. doi: 10.1016/j.bneo.2025.100071. eCollection 2025 May. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| D016190 | Carboplatin |
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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|
| Carboplatin | Drug | AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle. |
|
|
| Arsenic trioxide | Drug | 0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle. |
|
|
| Houston |
| Texas |
| 77030 |
| United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D056831 | Coordination Complexes |
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |