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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| Pfizer | INDUSTRY |
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This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Level 1 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2 |
|
| Phase 1 Dose Level 2 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin 75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2 |
|
| Phase I Dose Level 3 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 |
|
| Phase 2 Dose Level 1 | Experimental | 5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Azacitidine | Drug | Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities | MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine | Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward D Ball, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| Stanford University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 5-Azacitidine, Gemtuzumab ozogamicin 5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Gemtuzumab ozogamicin | Drug | Mylotarg given 2 times over 2 weeks |
|
|
| Stanford |
| California |
| 94305 |
| United States |
| Northside Hospital/BMTGA | Atlanta | Georgia | 30342 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 5-Azacitidine, Gemtuzumab ozogamicin 5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities | MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days. | Posted | Count of Participants | Participants | up to 28 days |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine | Posted | Count of Participants | Participants | Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 5-Azacitidine, Gemtuzumab ozogamicin 5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit Gemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks | 20 | 50 | 44 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cardiopulmonary arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Fever | Infections and infestations | Non-systematic Assessment |
| ||
| fever/pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Gram (-) Rods | Infections and infestations | Non-systematic Assessment |
| ||
| nausea, vomiting, abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hospitalized with syncopal event with intraventricular hemorrhage. | Infections and infestations | Non-systematic Assessment |
| ||
| Hypotension second to Mylotarg infusion | Cardiac disorders | Systematic Assessment |
| ||
| Infection documented/ relapsed AML | Infections and infestations | Non-systematic Assessment |
| ||
| Neutropenic Fever | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Refractory platlets | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| SIRS | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Gram Positive Infections | Infections and infestations | Non-systematic Assessment |
| ||
| Gram Negative Infections | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Abnormalities in liver function tests | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| SIRS/Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Weakness | General disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Electrolyte abnormalities | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward D. Ball, MD | University of California, San Diego | 858-822-6600 | tball@ucsd.edu |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D000079982 | Gemtuzumab |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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