Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

Conditions

• Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo allogeneic transplant
• Cytarabine — DRUG
  Given IV
• Daunorubicin Hydrochloride — DRUG
  Given IV
• Idarubicin — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Vorinostat — DRUG
  Given PO

Study Details

This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.

Key Dates

Start date

Feb 12, 2013

Status verified

Nov 2018

Primary completion

Jun 15, 2017

Completion

Jun 15, 2017

Study Design

Enrollment

754 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (standard dose cytarabine, daunorubicin hydrochloride)
  INDUCTION/RE-INDUCTION: Patients receive standard dose cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 15. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
• Experimental: Arm II (high-dose cytarabine, idarubicin)
  INDUCTION/RE-INDUCTION: Patients receive high dose cytarabine IV continuously on days 1-4 and idarubicin IV over 15 minutes on days 1-3. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive cytarabine IV continuously on days 1-3 and idarubicin IV over 15 minutes on days 1-2. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy.
• Experimental: Arm III (vorinostat, high-dose cytarabine, idarubicin)
  INDUCTION/RE-INDUCTIONI: Patients receive vorinostat PO TID on days 1-3, high-dose cytarabine IV continuously on days 4-7, and idarubicin IV over 15 minutes on days 4-6. Patients with residual blasts may receive re-induction treatment beginning on day 28. Patients achieving CR or CRi may proceed to allogeneic HSCT or to consolidation therapy. CONSOLIDATION: Patients receive vorinostat PO TID on days 1-3, cytarabine IV continuously on days 4-6, and idarubicin IV over 15 minutes on days 4-5. TRANSPLANT: Patients may undergo an allogeneic transplant after induction therapy or consolidation therapy. (Permanently closed to accrual, effective 6/2/2015) Patients previously randomized to Arm III may continue treatment with or without vorinostat.

Primary Outcome Measure

Event-free Survival (EFS) [ Time Frame: EFS assessed for up to 5 years, 2 year EFS reported ]

Locations (441)

Find similar trials in Birmingham, AL

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