Study on Bortezomib and Sorafenib Tosylate for Newly Diagnosed Acute Myeloid Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01371981

Provider View

This clinical trial is testing how well the drugs bortezomib and sorafenib tosylate work together with chemotherapy to treat patients who have just been diagnosed with acute myeloid leukemia (AML). These drugs may help stop cancer cells from growing by blocking certain enzymes.

Patient Parameters

Program Overview

The purpose of this study is to see if combining bortezomib and sorafenib tosylate with chemotherapy can effectively treat newly diagnosed acute myeloid leukemia (AML). These drugs work by stopping cancer cells from growing and dividing. The study will compare the survival rates and safety of this combination treatment with standard treatments.

Description

This study is divided into several parts, focusing on different treatment combinations for patients with newly diagnosed acute myeloid leukemia (AML). The main goals are to compare survival rates and the effectiveness of adding bortezomib and sorafenib tosylate to standard chemotherapy.

Patients will be divided into different groups based on their risk levels and genetic markers. Some will receive standard chemotherapy, while others will receive additional drugs like bortezomib or sorafenib tosylate. The study will also explore the possibility of using stem cell transplants for high-risk patients.

Throughout the study, researchers will monitor patients' responses to treatment, including how well the cancer is controlled and any side effects experienced. The study will also collect data on the quality of life of patients undergoing these treatments.

After completing the study treatment, patients will have regular follow-up visits to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be newly diagnosed with acute myeloid leukemia (AML).
  • Have not received any previous treatment for AML, except for certain medications like hydroxyurea or ATRA, which must be stopped before starting the study treatment.
  • Have at least 20% cancer cells in the bone marrow or specific genetic markers associated with AML.
  • Any performance status is eligible, meaning patients can participate regardless of their physical condition.

Exclusion Criteria

  • Have certain genetic conditions like Fanconi anemia or Shwachman syndrome.
  • Have other types of cancer or specific forms of leukemia, such as juvenile myelomonocytic leukemia or acute promyelocytic leukemia.
  • Are pregnant or breastfeeding.
  • Female patients of childbearing potential must have a negative pregnancy test before starting the study.
  • Sexually active patients must agree to use effective birth control during the study.

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