Trial Outcomes & Findings for Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment (NCT NCT01698879)
NCT ID: NCT01698879
Last Updated: 2021-01-27
Results Overview
Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
28 days after chemotherapy
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Cohort 1 Version 1.0
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1 Version 2.0
Idarubicin, cytarabine, Mylotarg
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
20
|
20
|
|
Overall Study
COMPLETED
|
5
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Version 1.0
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1 Version 2.0
Idarubicin, cytarabine, Mylotarg
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
Baseline characteristics by cohort
| Measure |
Cohort 1, Version 1.0
n=5 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4.
Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 Participants
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
49 years
n=7 Participants
|
61 years
n=5 Participants
|
61 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
9 Participants
n=7 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
5 Participants
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
16 Participants
n=4 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
11 Participants
n=7 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
15 Participants
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
29 Participants
n=4 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants • One patient has not been evaluated because has not received study treatment.
|
20 participants
n=7 Participants • One patient has not been evaluated because has not received study treatment.
|
20 participants
n=5 Participants • One patient has not been evaluated because has not received study treatment.
|
45 participants
n=4 Participants • One patient has not been evaluated because has not received study treatment.
|
|
Leucocites at diagnosis
|
13.48 Cells x 10^9/L
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
|
7.66 Cells x 10^9/L
n=7 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
|
6.96 Cells x 10^9/L
n=5 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
|
6.96 Cells x 10^9/L
n=4 Participants • The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
|
|
Citogenetic
Favorable
|
1 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
5 Participants
n=7 Participants • 1 patient not evaluable because has not received study treatment.
|
3 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
9 Participants
n=4 Participants • 1 patient not evaluable because has not received study treatment.
|
|
Citogenetic
Intermediate
|
3 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
13 Participants
n=7 Participants • 1 patient not evaluable because has not received study treatment.
|
12 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
28 Participants
n=4 Participants • 1 patient not evaluable because has not received study treatment.
|
|
Citogenetic
Adverse
|
1 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
2 Participants
n=7 Participants • 1 patient not evaluable because has not received study treatment.
|
5 Participants
n=5 Participants • 1 patient not evaluable because has not received study treatment.
|
8 Participants
n=4 Participants • 1 patient not evaluable because has not received study treatment.
|
PRIMARY outcome
Timeframe: 28 days after chemotherapyPopulation: Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.
Outcome measures
| Measure |
Cohort 1, Version 1.0
n=5 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 Participants
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Complete Remission of the Disease
Complete Response
|
NA Participants
It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
|
18 Participants
|
16 Participants
|
|
Complete Remission of the Disease
Partial Response
|
NA Participants
It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
|
1 Participants
|
2 Participants
|
|
Complete Remission of the Disease
Refractory
|
NA Participants
It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, weekly during treatment and at month 3 and month 6 after first induction.Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization
Outcome measures
| Measure |
Cohort 1, Version 1.0
n=5 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 Participants
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Secondary Toxicity to Mylotarg(R)
Grade III/IV Infection
|
0 percentage of participants
|
5 percentage of participants
|
30 percentage of participants
|
|
Secondary Toxicity to Mylotarg(R)
Grade IV Hematologic toxicity
|
0 percentage of participants
|
100 percentage of participants
|
95 percentage of participants
|
|
Secondary Toxicity to Mylotarg(R)
Grade II Hematologic toxicity
|
0 percentage of participants
|
0 percentage of participants
|
5 percentage of participants
|
|
Secondary Toxicity to Mylotarg(R)
Grade I/II Hepatic toxicity
|
20 percentage of participants
|
10 percentage of participants
|
10 percentage of participants
|
|
Secondary Toxicity to Mylotarg(R)
Grade III/IV hepatic toxicity
|
40 percentage of participants
|
5 percentage of participants
|
15 percentage of participants
|
|
Secondary Toxicity to Mylotarg(R)
Grade I/II Infection
|
0 percentage of participants
|
10 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly during treatment, at third month and at 6 months after last administration of Mylotargall deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred.
Outcome measures
| Measure |
Cohort 1, Version 1.0
n=5 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 Participants
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Mortality at Induction
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: One month before transplant, expected at 9 months after end of treatment.Population: Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible. This analysis has not been performed because data were not available for any of the cohorts studied.
Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months from complete remissionPopulation: Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
Rate of patients that have relapse after 6 months of obtained complete remission.
Outcome measures
| Measure |
Cohort 1, Version 1.0
n=20 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Relapse After 6 Months
|
30 percentage of participants
|
59 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 6 months after complete remissionPopulation: Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
rate of patients alive within 6 months of obtained complete remission
Outcome measures
| Measure |
Cohort 1, Version 1.0
n=20 Participants
Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
|
Cohort 1, Version 2.0
n=20 Participants
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
|---|---|---|---|
|
Survival After 6 Months
|
80 percentage of participants
|
80 percentage of participants
|
—
|
Adverse Events
Cohort 1
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Cohort 2
Serious events: 6 serious events
Other events: 19 other events
Deaths: 2 deaths
5 Patients Treated in Trial With Prrotocol Version 1.0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1
n=20 participants at risk
Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 participants at risk
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
5 Patients Treated in Trial With Prrotocol Version 1.0
n=5 participants at risk
Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg::
GO: 5 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. If no adequate response, GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
|---|---|---|---|
|
Nervous system disorders
Transient Ischemic event
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Infections and infestations
Septic shock
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Respiratory, thoracic and mediastinal disorders
Severe respiratory failure
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
10.0%
2/20 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Infections and infestations
Toxic megacolon
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pneumonia
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Infections and infestations
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
10.0%
2/20 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Hepatobiliary disorders
Hepatic Toxicity
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
40.0%
2/5 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/20 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
Other adverse events
| Measure |
Cohort 1
n=20 participants at risk
Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
Cohort 2
n=20 participants at risk
Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
|
5 Patients Treated in Trial With Prrotocol Version 1.0
n=5 participants at risk
Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg::
GO: 5 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. If no adequate response, GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Grade 4 hematologic toxicity
|
100.0%
20/20 • Number of events 20 • From October 2008 up to September 2016, 7 years and 11 months.
|
95.0%
19/20 • Number of events 19 • From October 2008 up to September 2016, 7 years and 11 months.
|
60.0%
3/5 • Number of events 3 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Hepatobiliary disorders
G1/2 Hepatic toxicity
|
10.0%
2/20 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
10.0%
2/20 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Hepatobiliary disorders
G3/G4 Hepatic Toxicity
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
15.0%
3/20 • Number of events 3 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Infections and infestations
Grade I/II infectous toxicity
|
10.0%
2/20 • Number of events 2 • From October 2008 up to September 2016, 7 years and 11 months.
|
25.0%
5/20 • Number of events 5 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
|
Infections and infestations
Grade 3 Infectous toxicity
|
5.0%
1/20 • Number of events 1 • From October 2008 up to September 2016, 7 years and 11 months.
|
30.0%
6/20 • Number of events 6 • From October 2008 up to September 2016, 7 years and 11 months.
|
0.00%
0/5 • From October 2008 up to September 2016, 7 years and 11 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60