Participant flow

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2026-06-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   INDUCTION (IND) 1Pts receive intrathecal (IT) cytarabine on day 1 and ADE with IV cytarabine over 1-30 minutes on days 1-10; daunorubicin hydrochloride IV over 1-15 minutes days1, 3, 5; etoposide IV 1-2 hours days 1-5. IND IILow risk (LR) pts receive cytarabine IT and ADE chemotherapy as in INDI. High risk (HR) cytarabine IT day 1, MA chemo comprising high-dose cytarabine IV over 1-3 hours days1-4, mitoxantrone IV over 15-30 minutes days 3-6. INTENSIFICATION (INT) I: cytarabine IT day 1, AE chemo with high-dose cytarabine IV over 1-3 hours, etoposide IV over 1-2 hours days 1-5. INT II: LR-cytarabine IT day 1; Induction II MA chemo. HR and no SCT donor - high-dose cytarabine IV over 3 hours days1, 2, 8, 9; asparaginase intramuscularly (IM) days 2,9. SCT: pts receive fludarabine phosphate IV over 30 minutes once daily days -5 to -2, busulfan IV over 2 hours 4 times daily days -5 to -2. Allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis.

   id

   FG000

   title

   Arm A

2. description

   IND I: Pts receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8. IND II: LR pts receive cytarabine IT, ADE chemotherapy, bortezomib as in IND I. HR pts receive cytarabine IT, MA as in IND II, Arm A (HR patients) and bortezomib IV on days 1, 4, 8. INT I: Pts receive cytarabine IT and AE in Arm A, Intensification II, and bortezomib IV on days 1, 4, 8. INT II: LR pts receive cytarabine IT on day 1, MA as in Arm A, IND II (HR patients), and bortezomib IV on days 1, 4, 8. HR pts with no donor for SCT receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, 9 and asparaginase intramuscularly (IM) on days 2 and 9. SCT - Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.Pts undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis.

   id

   FG001

   title

   Arm B

3. description

   IND II: Pts receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, sorafenib tosylate PO on days 9-36. INT I: Pts receive cytarabine IT and AE chemotherapy in Arm A, Intensification II, and sorafenib tosylate PO on daily on days 6-28. INT II: Pts receive cytarabine IT on day 1, MA chemotherapy as in Arm A, Induction II (HR patients), sorafenib tosylate PO on days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2, busulfan IV over 2 hours 4 times daily on days -5 to -2. Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for one year.

   id

   FG002

   title

   Arm C (Cohort 1)

4. description

   IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO at the time of known HR FLT3/ITD+ (including IND I \& concurrently with chemo). IND II: Pts receive cytarabine IT day (d) 1, cytarabine IV over 1-30 minutes on d 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours d 1-5, sorafenib tosylate PO d 9-36. INT I: Pts receive cytarabine IT and AE as in Arm A, INT II, and sorafenib tosylate PO on daily d 6-28. INT II: Pts receive cytarabine IT on d 1, MA as in Arm A, IND II (HR pts), sorafenib tosylate PO d 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on d -5 to -2, busulfan IV over 2 hours 4 times daily d -5 to -2. Pts undergo allogeneic SCT within 36-48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting d 40-100 after INT II or SCT for 1 year.

   id

   FG003

   title

   Arm C (Cohort 2)

5. description

   IND I: Pts receive cytarabine IT \& ADE as in Arm A, IND I \& sorafenib tosylate PO days 11-28. IND II: Pts receive cytarabine IT day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15 minutes days 1, 3, 5, etoposide IV over 1-2 hours days 1-5, sorafenib tosylate PO days 9-36. INT I: Pts receive cytarabine IT \& AE as in Arm A, INT II, \& sorafenib tosylate PO daily days 6-28. INT II: Pts receive cytarabine IT day 1, MA as in Arm A, IND II (HR patients), \& sorafenib tosylate PO days 7-34. SCT (HR patients with matched family \[MFD\] or unrelated donor): Pts receive fludarabine phosphate IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily days -5 to -2. Pts undergo allogeneic SCT within 36 to 48 hours after last busulfan dose. Pts receive GVHD prophylaxis. MAINTENANCE: Pts receive sorafenib tosylate PO starting day 40-100 after INT II or SCT for 1 year.

   id

   FG004

   title

   Arm C (Cohort 3)

6. description

   INDUCTION I: Patients with unknown FLT3/ITD status prior to study enrollment receive cytarabine IT and ADE chemotherapy as in Arm A, Induction I. If patients are determined to be HR FLT3/ITD+ no later than the end of Induction I they will be eligible to participate in Arm C.

   id

   FG005

   title

   Arm D

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         61

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         0

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         63

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         14

      6. group Id

         FG005

         num Subjects

         3

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         10

      6. group Id

         FG005

         num Subjects

         3

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         4

      type

      Ineligible

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Did not start treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         580

      2. group Id

         FG001

         num Subjects

         591

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         33

      5. group Id

         FG004

         num Subjects

         47

      6. group Id

         FG005

         num Subjects

         382

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         396

      2. group Id

         FG001

         num Subjects

         399

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         12

      5. group Id

         FG004

         num Subjects

         15

      6. group Id

         FG005

         num Subjects

         368

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         184

      2. group Id

         FG001

         num Subjects

         192

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         32

      6. group Id

         FG005

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results in the Participant Flow table summarize final (or analysis) arm assignment. Therefore, results for patients on Arms A, B, and D do not include any patient who transferred to Arm C.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice