Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment

• Sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias (Other)
• Overall Status: Completed
• CT.gov ID: NCT01698879
• Collaborator: (none)
• Enrollment: 46
• Locations: 6
• Arm: 1
• Duration (Months): 83.8
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.

Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of ara-C or adding a third drug.

Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ® selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.

Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.

Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of Mylotarg ® in the early stages of treatment of AML.

Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the CR rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.

Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.

Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated.

Condition or Disease	Intervention/Treatment	Phase
Novo Acute Myeloid Leukemia	Drug: Mylotarg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of de Novo Acute Myeloid Leukemia With the Combination of Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin (Mylotarg ®), Associated or Not Priming With G-CSF. Prospective Study of Efficacy and Toxicity
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Sep 14, 2016
• Actual Study Completion Date: Sep 26, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Single arm, three cohorts Idarubicin, cytarabine, Mylotarg.

Drug: Mylotarg; Cohort 1 version 1.0. GO: 6mg/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: 100 mg/m^2 IV days 1 to 7, to begin 4 hours after the administration of GO. Cohort 1.0 version 2.0: 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: 100 mg/m^2 IV days 1 to 7, to begin 4 hours after the administration of GO. Cohort 2: G-CSF: 150 mcg/m^2, SC, days 0 to 7. 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: 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.

Outcome Measures

Primary Outcome Measures

1. Complete Remission of the Disease [28 days after chemotherapy]

   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.

Secondary Outcome Measures

1. Secondary Toxicity to Mylotarg(R) [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

2. Mortality at Induction [Weekly during treatment, at third month and at 6 months after last administration of Mylotarg]

   all 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.

3. Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED [One month before transplant, expected at 9 months after end of treatment.]

   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.

4. Relapse After 6 Months [6 months from complete remission]

   Rate of patients that have relapse after 6 months of obtained complete remission.

5. Survival After 6 Months [6 months after complete remission]

   rate of patients alive within 6 months of obtained complete remission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with primary or "de novo" AML, different than promyelocytic or M3 subtype.

2. Age 18 to 70 years.

3. Written informed consent form

Exclusion Criteria:

1. Acute leukemia appeared after a myeloproliferative process or a myelodysplastic syndrome longer than 6 months, AML arising after another cured malignant disease (e.g. Hodgkin's disease), and secondary AML treated with alkylating agents or radiation.

2. Acute promyelocytic leukemia.

3. Relevant history of liver disease. Significant impaired liver function (bilirubin, AST or ALT ≥ 2.5 times the normal value) not attributable to leukemic infiltration.

4. Patients with prior heart failure.

5. Symptomatic chronic respiratory failure.

6. Positive serology for HIV, hepatitis C virus or its surface antigen.

7. Estimated life expectancy less than 3 months, despite treatment.

8. Pregnancy or breastfeeding at the time of inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
3	Hospital Clinic Barcelona	Barcelona		Spain	08036
4	Hospital Clinico Universitario de Salamanca	Salamanca		Spain	37007
5	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
6	Hospital Clínico Universitario de Valencia	Valencia		Spain	496010

Sponsors and Collaborators

• Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Investigators

• Study Chair: Jordi Sierra, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
• ClinicalTrials.gov Identifier: NCT01698879
• Other Study ID Numbers: ICOG-07; 2007-006295-11
• First Posted: Oct 3, 2012
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Gemtuzumab

Study Results

Participant Flow

Arm/Group Title	Cohort 1 Version 1.0	Cohort 1 Version 2.0	Cohort 2
Arm/Group Description	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.	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 (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.
Period Title: Overall Study
STARTED	6	20	20
COMPLETED	5	20	20
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1, Version 1.0	Cohort 1, Version 2.0	Cohort 2	Total
Arm/Group Description	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.	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 (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 of all reporting groups
Overall Participants	5	20	20	45
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56	49	61	61
Sex: Female, Male (Count of Participants)
Female	2 40%	9 45%	5 25%	16 35.6%
Male	3 60%	11 55%	15 75%	29 64.4%
Region of Enrollment (participants) [Number]
Spain	5 100%	20 100%	20 100%	45 100%
Leucocites at diagnosis (Cells x 10^9/L) [Median (Full Range) ]
Median (Full Range) [Cells x 10^9/L]	13.48	7.66	6.96	6.96
Citogenetic (Count of Participants)
Favorable	1 20%	5 25%	3 15%	9 20%
Intermediate	3 60%	13 65%	12 60%	28 62.2%
Adverse	1 20%	2 10%	5 25%	8 17.8%

Outcome Measures

1. Primary Outcome

Title	Complete Remission of the Disease
Description	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.
Time Frame	28 days after chemotherapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1, Version 1.0	Cohort 1, Version 2.0	Cohort 2
Arm/Group Description	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.	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 (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.
Measure Participants	5	20	20
Complete Response	NA NaN	18 90%	16 80%
Partial Response	NA NaN	1 5%	2 10%
Refractory	NA NaN	1 5%	2 10%

2. Secondary Outcome

Title	Secondary Toxicity to Mylotarg(R)
Description	Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization
Time Frame	Baseline, weekly during treatment and at month 3 and month 6 after first induction.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1, Version 1.0	Cohort 1, Version 2.0	Cohort 2
Arm/Group Description	Initial 5 patients of cohort 1 (closed due toxicity)	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 (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.
Measure Participants	5	20	20
Grade IV Hematologic toxicity	0 0%	100 500%	95 475%
Grade II Hematologic toxicity	0 0%	0 0%	5 25%
Grade I/II Hepatic toxicity	20 400%	10 50%	10 50%
Grade III/IV hepatic toxicity	40 800%	5 25%	15 75%
Grade I/II Infection	0 0%	10 50%	25 125%
Grade III/IV Infection	0 0%	5 25%	30 150%

3. Secondary Outcome

Title	Mortality at Induction
Description	all 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.
Time Frame	Weekly during treatment, at third month and at 6 months after last administration of Mylotarg

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1, Version 1.0	Cohort 1 Version 2.0	Cohort 2
Arm/Group Description	Initial 5 patients of cohort 1 (closed due toxicity)	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 (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.
Measure Participants	5	20	20
Count of Participants [Participants]	1 20%	0 0%	2 10%

4. Secondary Outcome

Title	Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED
Description	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.
Time Frame	One month before transplant, expected at 9 months after end of treatment.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1, Version 1.0	Cohort 1, Version 2.0	Cohort 2
Arm/Group Description	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.	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 (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.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Relapse After 6 Months
Description	Rate of patients that have relapse after 6 months of obtained complete remission.
Time Frame	6 months from complete remission

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1, Version 2.0	Cohort 2
Arm/Group Description	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 (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.
Measure Participants	20	20
Number [percentage of participants]	30 600%	59 295%

6. Secondary Outcome

Title	Survival After 6 Months
Description	rate of patients alive within 6 months of obtained complete remission
Time Frame	6 months after complete remission

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	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 (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.
Measure Participants	20	20
Number [percentage of participants]	80 1600%	80 400%

Adverse Events

Time Frame	From October 2008 up to September 2016, 7 years and 11 months.
Arm/Group Title	Cohort 1		Cohort 2		5 Patients Treated in Trial With Prrotocol Version 1.0
Arm/Group Description	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 (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.		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.
All Cause Mortality
	Cohort 1		Cohort 2		5 Patients Treated in Trial With Prrotocol Version 1.0
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		2/20 (10%)		1/5 (20%)
Serious Adverse Events
	Cohort 1		Cohort 2		5 Patients Treated in Trial With Prrotocol Version 1.0
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		6/20 (30%)		2/5 (40%)
Blood and lymphatic system disorders
Anemia	1/20 (5%)	1	0/20 (0%)	0	0/5 (0%)	0
Neutropenia	1/20 (5%)	1	0/20 (0%)	0	0/5 (0%)	0
Hepatobiliary disorders
Liver failure	0/20 (0%)	0	1/20 (5%)	1	0/5 (0%)	0
Hepatic Toxicity	0/20 (0%)	0	0/20 (0%)	0	2/5 (40%)	2
Infections and infestations
Septic shock	0/20 (0%)	0	1/20 (5%)	1	0/5 (0%)	0
Toxic megacolon	0/20 (0%)	0	1/20 (5%)	1	0/5 (0%)	0
Febrile neutropenia	1/20 (5%)	1	2/20 (10%)	2	0/5 (0%)	0
Nervous system disorders
Transient Ischemic event	0/20 (0%)	0	1/20 (5%)	1	0/5 (0%)	0
Respiratory, thoracic and mediastinal disorders
Severe respiratory failure	0/20 (0%)	0	2/20 (10%)	2	0/5 (0%)	0
Bilateral pneumonia	1/20 (5%)	1	0/20 (0%)	0	0/5 (0%)	0
Acute Pulmonary Edema	1/20 (5%)	1	0/20 (0%)	0	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	Cohort 1		Cohort 2		5 Patients Treated in Trial With Prrotocol Version 1.0
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/20 (100%)		19/20 (95%)		3/5 (60%)
Blood and lymphatic system disorders
Grade 4 hematologic toxicity	20/20 (100%)	20	19/20 (95%)	19	3/5 (60%)	3
Hepatobiliary disorders
G1/2 Hepatic toxicity	2/20 (10%)	2	2/20 (10%)	2	0/5 (0%)	0
G3/G4 Hepatic Toxicity	1/20 (5%)	1	3/20 (15%)	3	0/5 (0%)	0
Infections and infestations
Grade I/II infectous toxicity	2/20 (10%)	2	5/20 (25%)	5	0/5 (0%)	0
Grade 3 Infectous toxicity	1/20 (5%)	1	6/20 (30%)	6	0/5 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.