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Trial record 83 of 144 for:    "Acute promyelocytic leukemia"

Vorinostat in Treating Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00305773
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : May 16, 2013
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Erythroid Leukemia (M6)
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 Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
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 Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Refractory Cytopenia With Multilineage Dysplasia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Intervention Drug: vorinostat
Enrollment 37
Recruitment Details A total of 37 participants were enrolled into this trial between January 2006 and August 2007. One patient on Arm A was ineligible; this participant was included in all analyses.
Pre-assignment Details  
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 15 22
Completed 1 4
Not Completed 14 18
Reason Not Completed
Death             3             2
Adverse Event             1             2
Alternative Treatment             4             4
Physician Decision             1             1
Withdrawal by Subject             1             4
Disease Progression             1             3
All other reasons             3             2
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat) Total
Hide Arm/Group Description Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 15 22 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 22 participants 37 participants
67
(41 to 79)
67
(28 to 81)
67
(28 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 22 participants 37 participants
Female
5
  33.3%
5
  22.7%
10
  27.0%
Male
10
  66.7%
17
  77.3%
27
  73.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 22 participants 37 participants
15 22 37
Disease status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 22 participants 37 participants
Relapsed 12 16 28
Untreated 3 6 9
AML disease classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 22 participants 37 participants
Relapsed AML with good risk cytogenetics 0 0 0
All other relapsed AML 12 16 28
Untreated AML patients >= 65 years old 3 3 6
Untreated AML patients with MDS-AML 0 3 3
Untreated AML with >= 3 cytogenetic abnnormalities 0 0 0
1.Primary Outcome
Title Confirmed Complete Response (CR) Rate
Hide Description

The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants.

According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC > 1500/mL, platelets > 100000/mL, no circulating blasts, bone marrow cellularity >20% (biopsy), trilineage maturation, < 5% bone marrow blasts, no auer rods and no extramedullary disease.

Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description:
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 23)
4.5
(0.4 to 24)
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier
Time Frame Duration of study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description:
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description:
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 22
Median (95% Confidence Interval)
Unit of Measure: days
105
(55 to 223)
153
(58 to 229)
4.Secondary Outcome
Title Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events
Hide Description

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

Description of Grades:

Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Time Frame Duration of study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description:
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 22
Measure Type: Number
Unit of Measure: participants
10 17
5.Other Pre-specified Outcome
Title Time to Treatment Failure (TTF)
Hide Description Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.
Time Frame Duration of treatment (up to 17 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description:
Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 22
Median (90% Confidence Interval)
Unit of Measure: days
42
(26 to 57)
46
(20 to 71)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Hide Arm/Group Description Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      16/22 (72.73%)    
Blood and lymphatic system disorders     
Blood disorder  1  2/15 (13.33%)  2 0/22 (0.00%)  0
Febrile neutropenia  1  1/15 (6.67%)  1 3/22 (13.64%)  3
Hemoglobin decreased  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Cardiac disorders     
Sinus tachycardia  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Cecal obstruction  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Constipation  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Diarrhea  1  0/15 (0.00%)  0 4/22 (18.18%)  4
Lower gastrointestinal hemorrhage  1  1/15 (6.67%)  2 0/22 (0.00%)  0
Nausea  1  1/15 (6.67%)  1 3/22 (13.64%)  3
Oral hemorrhage  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Upper gastrointestinal hemorrhage  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Vomiting  1  1/15 (6.67%)  1 3/22 (13.64%)  3
General disorders     
Chills  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Death NOS  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Disease progression  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Fatigue  1  3/15 (20.00%)  3 7/22 (31.82%)  7
General symptom  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Sudden death  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations     
Catheter related infection  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Gingival infection  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Pharyngitis  1  0/15 (0.00%)  0 1/22 (4.55%)  2
Pneumonia  1  1/15 (6.67%)  1 2/22 (9.09%)  2
Sepsis  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Urinary tract infection  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Injury, poisoning and procedural complications     
Fracture  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Investigations     
Creatine phosphokinase increased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Leukocyte count decreased  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Neutrophil count decreased  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Platelet count decreased  1  1/15 (6.67%)  1 4/22 (18.18%)  4
Metabolism and nutrition disorders     
Acidosis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Bone pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Nervous system disorders     
Dizziness  1  2/15 (13.33%)  3 0/22 (0.00%)  0
Intracranial hemorrhage  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Psychiatric disorders     
Confusion  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Dyspnea  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Epistaxis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Hypoxia  1  1/15 (6.67%)  1 2/22 (9.09%)  2
Pharyngeal mucositis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Pleuritic pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Pneumonitis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders     
Rash desquamating  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Skin disorder  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Sweating  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Vascular disorders     
Thrombosis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Once Daily Vorinostat) Arm B (Thrice Daily Vorinostat)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/15 (93.33%)      21/22 (95.45%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/15 (6.67%)  2 3/22 (13.64%)  4
Hemoglobin decreased  1  7/15 (46.67%)  13 6/22 (27.27%)  11
Gastrointestinal disorders     
Abdominal pain  1  0/15 (0.00%)  0 2/22 (9.09%)  3
Diarrhea  1  3/15 (20.00%)  4 11/22 (50.00%)  24
Dyspepsia  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Dysphagia  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Ear, nose and throat examination abnormal  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Flatulence  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorder  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Mucositis oral  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Nausea  1  6/15 (40.00%)  8 13/22 (59.09%)  15
Stomach pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Vomiting  1  1/15 (6.67%)  1 7/22 (31.82%)  7
General disorders     
Chest pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Edema limbs  1  0/15 (0.00%)  0 2/22 (9.09%)  5
Fatigue  1  12/15 (80.00%)  22 15/22 (68.18%)  52
Pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations     
Bladder infection  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Gingival infection  1  1/15 (6.67%)  1 1/22 (4.55%)  2
Opportunistic infection  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Pneumonia  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Sinusitis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Injury, poisoning and procedural complications     
Radiation recall reaction (dermatologic)  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Investigations     
Alanine aminotransferase increased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Aspartate aminotransferase increased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Blood bilirubin increased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
INR increased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Leukocyte count decreased  1  6/15 (40.00%)  10 4/22 (18.18%)  12
Neutrophil count decreased  1  13/15 (86.67%)  25 19/22 (86.36%)  45
Platelet count decreased  1  14/15 (93.33%)  28 19/22 (86.36%)  55
Metabolism and nutrition disorders     
Anorexia  1  4/15 (26.67%)  5 9/22 (40.91%)  19
Blood glucose increased  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Dehydration  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Serum potassium decreased  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Bone pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Chest wall pain  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Muscle weakness  1  1/15 (6.67%)  2 2/22 (9.09%)  2
Myalgia  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Nervous system disorders     
Ataxia  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Dizziness  1  0/15 (0.00%)  0 1/22 (4.55%)  2
Dysgeusia  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Headache  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Renal and urinary disorders     
Urinary incontinence  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/15 (6.67%)  1 1/22 (4.55%)  1
Cough  1  1/15 (6.67%)  1 2/22 (9.09%)  2
Dyspnea  1  6/15 (40.00%)  7 7/22 (31.82%)  11
Hiccups  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Pharyngeal mucositis  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Pharyngolaryngeal pain  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin  1  1/15 (6.67%)  1 0/22 (0.00%)  0
Petechiae  1  1/15 (6.67%)  1 2/22 (9.09%)  2
Rash desquamating  1  2/15 (13.33%)  2 0/22 (0.00%)  0
Sweating  1  0/15 (0.00%)  0 2/22 (9.09%)  2
Vascular disorders     
Hematoma  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Hemorrhage  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Hot flashes  1  0/15 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Gore, MD
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
EMail: gorest@jhmi.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305773     History of Changes
Other Study ID Numbers: NCI-2012-01470
NCI-2012-01470 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000465213
JHOC-J0557
MAYO-MC0483
JHOC-J0550
NCI-6882
MC0483 ( Other Identifier: Mayo Clinic )
6882 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2006
First Posted: March 22, 2006
Results First Submitted: March 28, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 19, 2014