TriangleNCT00372593 · OUTCOME
Time to Marrow Recovery
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Mean days
- Interval / dispersion
- Standard Deviation
- Time frame
- At 25 days after treatment with Induction I, Induction II, and Intensification I
What was measured
Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.
Analysis population: Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)
Groups in this outcome
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
| Group | Source count |
|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 511 |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 511 |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 6 |
Reported measurements
During Induction I (days 0 - 28 of therapy)
| Group | Source count |
|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 380 |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 391 |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 30.56 | 6.96 | Not reported | Not reported | Not reported |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 30.56 | 6.47 | Not reported | Not reported | Not reported |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 29.17 | 2.79 | Not reported | Not reported | Not reported |
During Induction II (days 29 - 56 of therapy)
| Group | Source count |
|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 394 |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 405 |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 28.54 | 6.69 | Not reported | Not reported | Not reported |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 28.52 | 6.25 | Not reported | Not reported | Not reported |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 26.6 | 4.83 | Not reported | Not reported | Not reported |
During Intensification I (days 57 - 84 of therapy)
| Group | Source count |
|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 355 |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 383 |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 27.51 | 5.95 | Not reported | Not reported | Not reported |
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 28.10 | 6.32 | Not reported | Not reported | Not reported |
| Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 24.5 | 3.70 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.96
- value
- 30.56
- group Id
- OG001
- spread
- 6.47
- value
- 30.56
- group Id
- OG002
- spread
- 2.79
- value
- 29.17
- denoms
- counts
- group Id
- OG000
- value
- 380
- group Id
- OG001
- value
- 391
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- During Induction I (days 0 - 28 of therapy)
- categories
- measurements
- group Id
- OG000
- spread
- 6.69
- value
- 28.54
- group Id
- OG001
- spread
- 6.25
- value
- 28.52
- group Id
- OG002
- spread
- 4.83
- value
- 26.6
- denoms
- counts
- group Id
- OG000
- value
- 394
- group Id
- OG001
- value
- 405
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- During Induction II (days 29 - 56 of therapy)
- categories
- measurements
- group Id
- OG000
- spread
- 5.95
- value
- 27.51
- group Id
- OG001
- spread
- 6.32
- value
- 28.10
- group Id
- OG002
- spread
- 3.70
- value
- 24.5
- denoms
- counts
- group Id
- OG000
- value
- 355
- group Id
- OG001
- value
- 383
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- During Intensification I (days 57 - 84 of therapy)
- denoms
- counts
- group Id
- OG000
- value
- 511
- group Id
- OG001
- value
- 511
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
- id
- OG000
- title
- Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome
- description
- Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
- id
- OG001
- title
- Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome
- description
- Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
- id
- OG002
- title
- Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome
- param Type
- MEAN
- population Description
- Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)
- reporting Status
- POSTED
- time Frame
- At 25 days after treatment with Induction I, Induction II, and Intensification I
- title
- Time to Marrow Recovery
- type
- SECONDARY
- unit Of Measure
- Mean days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice