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Trial record 16 of 91 for:    gemtuzumab ozogamicin

Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT00766116
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Celgene Corporation
Pfizer
Information provided by (Responsible Party):
Edward Ball, University of California, San Diego

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: 5-Azacitidine
Drug: Gemtuzumab ozogamicin
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

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

Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description

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

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  52.0%
>=65 years
24
  48.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
26
  52.0%
Male
24
  48.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
 100.0%
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities
Hide Description 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.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 Cohort 1 Phase 1 Cohort 2 Phase 1 Cohort 3
Hide Arm/Group Description:
5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 2 days
5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 4 days
5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 6 days
Overall Number of Participants Analyzed 6 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine
Hide Description [Not Specified]
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
36
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

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

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   20/50 (40.00%)    
Blood and lymphatic system disorders   
Neutropenic Fever   11/50 (22.00%)  13
Cardiac disorders   
Cardiopulmonary arrest *  1/50 (2.00%)  1
Hypotension second to Mylotarg infusion   1/50 (2.00%)  1
Gastrointestinal disorders   
Abdominal Pain *  1/50 (2.00%)  1
nausea, vomiting, abdominal pain *  1/50 (2.00%)  1
Infections and infestations   
Pneumonia *  2/50 (4.00%)  2
Fever *  1/50 (2.00%)  1
fever/pneumonia *  1/50 (2.00%)  1
Gram (-) Rods *  1/50 (2.00%)  1
Hospitalized with syncopal event with intraventricular hemorrhage. *  1/50 (2.00%)  1
Infection documented/ relapsed AML *  1/50 (2.00%)  1
Refractory platlets *  1/50 (2.00%)  1
Sepsis *  2/50 (4.00%)  2
SIRS *  1/50 (2.00%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   44/50 (88.00%)    
Blood and lymphatic system disorders   
Febrile Neutropenia   38/50 (76.00%)  46
Abnormalities in liver function tests   5/50 (10.00%)  5
Electrolyte abnormalities   6/50 (12.00%)  6
Gastrointestinal disorders   
Mucositis *  6/50 (12.00%)  6
General disorders   
Weakness *  5/50 (10.00%)  15
Infections and infestations   
Gram Positive Infections *  7/50 (14.00%) 
Gram Negative Infections *  2/50 (4.00%)  2
Pneumonia *  5/50 (10.00%)  8
SIRS/Sepsis *  5/50 (10.00%)  5
Respiratory, thoracic and mediastinal disorders   
Respiratory failure *  2/50 (4.00%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward D. Ball, MD
Organization: University of California, San Diego
Phone: 858-822-6600
EMail: tball@ucsd.edu
Layout table for additonal information
Responsible Party: Edward Ball, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00766116     History of Changes
Other Study ID Numbers: 090516
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: January 29, 2018
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019