Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS.

Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.


Clinical Trial Description

The Study Drugs:

Vorinostat is designed to change the gene expression profile of leukemia cells, which may cause the cells to die.

Idarubicin is designed to cause breaks in DNA (the genetic material of cells). This may cause cancer cells to die.

Ara-C is designed to insert itself into DNA of cancer cells and stop the DNA from repairing itself.

This dose combination has not been tested in humans before, at this dose level and schedule.

Study Drug Administration:

Induction Therapy:

If you are found to be eligible to take part in this study, you will begin induction therapy. During induction therapy, the dose level of vorinostat may vary based on when you join the study and on the side effects seen in other participants. The first group of 3 participants will receive the highest dose level of vorinostat. If intolerable side effects are experienced, the next group of 3 participants will receive a lower dose of vorinostat. This will continue until the highest dose of vorinostat with no intolerable side effects is found. The dose levels of the other drugs will not change.

In the Induction phase, you will receive 1 or 2 induction cycles of therapy on the following schedule:

- On Days 1-3, you will take vorinostat by mouth 3 times a day.

- On Days 4-6, you will receive idarubicin through a needle in your vein over 1 hour.

- On Days 4-7, you will receive ara-C by vein as a non-stop infusion.

- On Days 4-7, you will receive solumedrol or dexamethasone to help reduce the risk of side effects associated with ara-C. The drug will be given by vein over a few seconds.

Consolidation Therapy:

If the disease responds during Induction, you may be able to receive up to 5 additional 4-6 week study cycles. During these Consolidation Cycles, you will take the study drugs on the following cycle:

- On Days 1-3, you will take vorinostat by mouth 3 times a day.

- On Days 4 and 5, you will receive idarubicin through a needle in your vein over 5 minutes.

- On Days 4-6, you will receive ara-C by vein as a non-stop infusion.

- On Days 4 and 5, you will also receive either solumedrol or dexamethasone by vein over a few seconds.

Maintenance Therapy:

If you go into remission, you will begin maintenance therapy. While on maintenance therapy, you will take vorinostat by mouth 3 times a day on Days 1-14 of each 28-day study cycle. You may have up to 12 Maintenance Cycles.

Study Visits:

At least every week during Cycle 1, and then at least once a month during each additional cycle, blood (about 1-2 teaspoons) will be drawn for routine tests. You will also have routine bone marrow aspirates and biopsies before initiating treatment and approximately on Day 21 and Day 28 after initiating therapy.

Length of Study:

You may continue to receive the study drugs for up to 18 cycles. You will be taken off study early if the disease gets worse or intolerable side effects occur.

This is an investigational study. Idarubicin is FDA approved for use in combination with other approved drugs for the treatment of AML. Vorinostat is FDA approved and commercially available for the treatment of some forms of cutaneous lymphoma. Ara-C is FDA approved for use in the treatment of leukemia. The use of these drugs together is investigational.

Up to 105 patients will take part in this study. All will be enrolled at MD Anderson. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00656617
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date April 2008
Completion date February 2014

See also
  Status Clinical Trial Phase
Recruiting NCT04240002 - A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Completed NCT05488613 - Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Terminated NCT02927938 - Leukemia Stem Cell Detection in Acute Myeloid Leukemia Phase 3
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Recruiting NCT03188874 - Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Completed NCT00071006 - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04079296 - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) Phase 1/Phase 2
Completed NCT04509622 - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML) Phase 3
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Completed NCT02252107 - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1 Phase 2
Terminated NCT01463410 - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler N/A
Completed NCT01242774 - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML) Phase 1
Terminated NCT02134782 - Yoga Fatigue Study N/A
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Completed NCT03625505 - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04266795 - A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Phase 2