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Trial record 35 of 91 for:    gemtuzumab ozogamicin

Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00673153
Recruitment Status : Terminated
First Posted : May 7, 2008
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roland Walter, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: gemtuzumab ozogamicin
Drug: vorinostat
Other: laboratory biomarker analysis
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 31
Completed 30
Not Completed 1
Arm/Group Title Arm I
Hide Arm/Group Description

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
72
(61 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
11
  35.5%
Male
20
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
Risk Group   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Poor-risk Group
10
  32.3%
Good-risk Group
21
  67.7%
[1]
Measure Description:

Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1

Performance status based on Eastern Cooperative Oncology Group's scale, abbreviated below:

0 Fully active

  1. Restricted in strenuous activity but capable of a light or sedentary work activities,
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities;
  3. Capable of only limited selfcare;
  4. Completely disabled; cannot carry on any selfcare; confined to bed or chair
  5. Dead
1.Primary Outcome
Title Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group)
Hide Description [Not Specified]
Time Frame after completion of induction therapy, administered every 21-42 days for up to two courses
Hide Outcome Measure Data
Hide Analysis Population Description
Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1
Arm/Group Title Arm I
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
6
  28.6%
2.Primary Outcome
Title Number of Participants Alive at Day 30 (Poor-risk Group)
Hide Description [Not Specified]
Time Frame At day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Poor-risk Group: patients aged ≥70 years and performance status 2-3
Arm/Group Title Arm I
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
3.Secondary Outcome
Title Relapse-free Survival (Good- and Poor-risk Group)
Hide Description [Not Specified]
Time Frame At relapse
Hide Outcome Measure Data
Hide Analysis Population Description
Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1
Arm/Group Title Arm I
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
7
  22.6%
4.Secondary Outcome
Title Number of Participants Achieving CR or CRi With Induction Therapy (Poor-risk Group)
Hide Description [Not Specified]
Time Frame after completion of induction therapy, administered every 21-42 days for up to two courses
Hide Outcome Measure Data
Hide Analysis Population Description
Poor-risk Group: patients aged ≥70 years and performance status 2-3
Arm/Group Title Arm I
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
5.Secondary Outcome
Title Number of Participants Alive at Day 30 (Good-risk Group)
Hide Description [Not Specified]
Time Frame At day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1
Arm/Group Title Arm I
Hide Arm/Group Description:

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .

CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.

MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

gemtuzumab ozogamicin: Given IV

vorinostat: Given orally

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   12/31 (38.71%)    
Blood and lymphatic system disorders   
Epistaxis  1/31 (3.23%)  1
Gastrointestinal disorders   
GI Bleed  1/31 (3.23%)  1
General disorders   
Death  4/31 (12.90%)  4
Infections and infestations   
Pneumonia  2/31 (6.45%)  2
Neutropenic Fever  5/31 (16.13%)  5
Septic Shock  1/31 (3.23%)  1
E-coli Infection  1/31 (3.23%)  1
Injury, poisoning and procedural complications   
Fall  1/31 (3.23%)  1
Skin and subcutaneous tissue disorders   
Perirectal cellulitis  1/31 (3.23%)  1
Surgical and medical procedures   
Bleeding at PICC site  1/31 (3.23%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%) # Events
Total   29/31 (93.55%)    
Blood and lymphatic system disorders   
Neutropenia  19/31 (61.29%)  26
Thrombocytopenia  18/31 (58.06%)  22
Anemia  10/31 (32.26%)  10
Hypokalemia  1/31 (3.23%)  1
White blood cell decreased  2/31 (6.45%)  3
Hemorrhage, post bone marrow  1/31 (3.23%)  1
Cardiac disorders   
Cardiac arrhythmia  2/31 (6.45%)  5
Heart Failure  1/31 (3.23%)  2
Non-ST-elevation myocardial infarction  1/31 (3.23%)  1
Eye disorders   
Blurred Vision  1/31 (3.23%)  1
Gastrointestinal disorders   
Nausea  2/31 (6.45%)  2
Diarrhea  3/31 (9.68%)  4
Gingival bleeding  1/31 (3.23%)  2
Hemorrhoidal hemorrhage  1/31 (3.23%)  1
Constipation  1/31 (3.23%)  2
Gastrointestinal Bleed  2/31 (6.45%)  2
Appendix Fistula  1/31 (3.23%)  1
General disorders   
Chills  3/31 (9.68%)  3
Fatigue  3/31 (9.68%)  3
Edema/Swelling  2/31 (6.45%)  2
Infusion related reaction  1/31 (3.23%)  1
Malaise  1/31 (3.23%)  1
Immune system disorders   
Streptococcus salivarius  1/31 (3.23%)  1
Infections and infestations   
Neutropenic Fever  7/31 (22.58%)  14
Sepsis  1/31 (3.23%)  1
Bacteremia  3/31 (9.68%)  3
Investigations   
Weight loss  2/31 (6.45%)  2
Creatinine increased  3/31 (9.68%)  3
Increased lactate dehydrogenase  1/31 (3.23%)  1
Metabolism and nutrition disorders   
Anorexia  2/31 (6.45%)  2
Hyperglycemia  1/31 (3.23%)  1
Diaphoresis  1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders   
Chest pain  2/31 (6.45%)  3
Muscle Weakness  2/31 (6.45%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pulmonary Nodules  1/31 (3.23%)  1
Nervous system disorders   
Headache  1/31 (3.23%)  1
Psychiatric disorders   
Confusion  2/31 (6.45%)  2
Renal and urinary disorders   
Increased urinary frequency  1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1/31 (3.23%)  1
Pneumonia  4/31 (12.90%)  4
Dyspnea  2/31 (6.45%)  2
Epistaxis  3/31 (9.68%)  3
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1/31 (3.23%)  1
Vascular disorders   
Hematoma, scalp  1/31 (3.23%)  1
Orthostatic hypotension  2/31 (6.45%)  2
Hypertension  1/31 (3.23%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor CAN require changes to the communication and CAN extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roland B. Walter, MD, PhD, MS
Organization: Fred Hutch Cancer Research Center
Phone: (206) 667-3599
Layout table for additonal information
Responsible Party: Roland Walter, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00673153     History of Changes
Other Study ID Numbers: 2200.00
NCI-2010-00401 ( Registry Identifier: National Cancer Institute (NCI) )
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: March 15, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017