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MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00462605
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : April 17, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Lymphoblastic Leukemia in Remission
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(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)
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia
Refractory Anemia With Excess Blasts
Refractory Anemia With Ringed Sideroblasts
Refractory Cytopenia With Multilineage Dysplasia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: entinostat
Drug: sargramostim
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Period Title: Overall Study
Started 24
Completed 10
Not Completed 14
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
71
(52 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
9
  37.5%
Male
15
  62.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
 100.0%
1.Primary Outcome
Title Response (Complete and Partial Response) in Patients With Myeloid Disorders
Hide Description Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Remission (CR)
0
   0.0%
Partial Remission (PR)
1
  10.0%
Hematologic Improvement in Neutrophils (HI-N)
2
  20.0%
Stable Disease (SD)
5
  50.0%
Progressive Disease (PD)
2
  20.0%
2.Secondary Outcome
Title Clinical Activity Assessed by Change in Peripheral Blood Counts
Hide Description [Not Specified]
Time Frame Baseline and after 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: cell/mm^3
ANC +/- SEM at baseline 578  (126)
ANC +/- SEM after 2 cycles 1137  (384)
3.Secondary Outcome
Title Clinical Activity Assessed by Change in Transfusion Requirements
Hide Description [Not Specified]
Time Frame Baseline and after 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the limited number of clinical responders, this outcome was not measured.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)
Hide Description [Not Specified]
Time Frame Baseline and 6, 12, 24, and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the limited number of clinical responders, the research assay was not done.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry
Hide Description [Not Specified]
Time Frame Baseline and 6, 12, 24, and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the limited number of clinical responders, the research assay was not done.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.

entinostat: Given PO

sargramostim: Given SC

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   19/24 (79.17%) 
Cardiac disorders   
Pericardial effusion  1/24 (4.17%) 
Gastrointestinal disorders   
anorexia  1/24 (4.17%) 
General disorders   
Fatigue  2/24 (8.33%) 
Infections and infestations   
Neutropenic infection  5/24 (20.83%) 
Musculoskeletal and connective tissue disorders   
Bone Pain  3/24 (12.50%) 
Weakness  1/24 (4.17%) 
Joint pain  1/24 (4.17%) 
Nervous system disorders   
vasovagal episode  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
hypoxia  2/24 (8.33%) 
cough  1/24 (4.17%) 
pneumonitis  1/24 (4.17%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Arm I
Affected / at Risk (%)
Total   6/24 (25.00%) 
Gastrointestinal disorders   
GI bleed  1/24 (4.17%) 
General disorders   
fatigue  1/24 (4.17%) 
Infections and infestations   
Neutropenic infection  1/24 (4.17%) 
Metabolism and nutrition disorders   
hyponatremia  2/24 (8.33%) 
hypocalcemia  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness  2/24 (8.33%) 
back pain  1/24 (4.17%) 
Nervous system disorders   
confusion  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/24 (4.17%) 
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: B. Douglas Smith
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-614-5068
EMail: smithdo@jhmi.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00462605     History of Changes
Obsolete Identifiers: NCT00466115
Other Study ID Numbers: NCI-2009-00195
J06114
U01CA070095 ( U.S. NIH Grant/Contract )
First Submitted: April 18, 2007
First Posted: April 19, 2007
Results First Submitted: March 6, 2017
Results First Posted: April 17, 2017
Last Update Posted: July 18, 2017