RecruitingPhase 2NCT01515527

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Sponsor

M.D. Anderson Cancer Center

Enrollment

160 participants

Start Date

Feb 7, 2012

Study Type

INTERVENTIONAL

Conditions

Leukemia

Summary

The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs — cladribine, low-dose cytarabine, and decitabine — used in alternating cycles, to treat older or less-fit adults with acute myeloid leukemia (AML, a fast-growing blood cancer) or high-risk myelodysplastic syndrome (MDS, a condition where bone marrow does not make enough healthy blood cells). **You may be eligible if...** - You have been newly diagnosed with AML or high-risk MDS (with at least 10% abnormal cells in the bone marrow) - You are 60 years of age or older, OR you are younger but are not a good candidate for intensive standard chemotherapy - You may have had some prior limited therapy but this would be your first intensive treatment for AML **You may NOT be eligible if...** - You have already received aggressive induction chemotherapy for AML - You have certain other serious health conditions that would make this treatment too risky - You are under 60 and considered fit enough for standard intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCladribine

Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles. Consolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.

DRUGCytarabine

Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles. Consolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.

DRUGDecitabine

Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.