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High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

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ClinicalTrials.gov Identifier: NCT00774046
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : June 24, 2013
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions Drug: Ara-C
Drug: Mitoxantrone
Drug: Etoposide
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction Chemotherapy Followed by Stem Cell Transplant
Hide Arm/Group Description Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Period Title: Screening
Started 116
Completed 60
Not Completed 56
Reason Not Completed
Not eligible             56
Period Title: Enrollment
Started 60
Completed 32
Not Completed 28
Reason Not Completed
Desired other therapy/refused             28
Period Title: Induction Therapy
Started 32
Completed 32
Not Completed 0
Period Title: Stem Cell Mobilization
Started 10 [1]
Completed 7
Not Completed 3
Reason Not Completed
Count too low (2), sudden death (1)             3
[1]
For mobilization, the patient must have had a CR and not been a candidate for allogeneic transplant
Period Title: Autologous Transplant
Started 4 [1]
Completed 4
Not Completed 0
[1]
2 patients died in remission and 1 relapsed without having received transplant
Arm/Group Title All Patients
Hide Arm/Group Description Ara-C Mitoxantrone Etoposide
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
56
(23 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
18
  56.3%
Male
14
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Response to Induction Chemotherapy (CR or PR)
Hide Description Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made
Time Frame Day 28-40
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.2
(63.6 to 92.8)
2.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Up to 2000 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 32
Median (Inter-Quartile Range)
Unit of Measure: Days
399
(125 to 812)
3.Primary Outcome
Title Relapse-free Survival
Hide Description Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
Time Frame Up to 2000 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 32
Median (Inter-Quartile Range)
Unit of Measure: Days
415 [1] 
(141 to NA)
[1]
Due to censoring, the 75th percentile was not reached.
4.Secondary Outcome
Title Feasibility of Stem Cell Collection
Hide Description Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg
Time Frame 1-5 days from initiation of stem cell collection
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of patients in CR who underwent mobilization and attempted stem cell collection.
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(35 to 93)
5.Secondary Outcome
Title Numbers of Stem Cells Collected
Hide Description [Not Specified]
Time Frame 1-5 days from initiation of stem cell collection
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of patients in CR who underwent mobilization and attempted stem cell collection.
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: 10^6 CD34+ cells/kg
4.50
(0 to 30.31)
6.Secondary Outcome
Title Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Hide Description [Not Specified]
Time Frame Up to 817 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of patients undergoing autologous stem cell transplant
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: Days
294 [1] 
(133 to NA)
[1]
Largest observation censored at 817 days
7.Secondary Outcome
Title Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Hide Description [Not Specified]
Time Frame Up to 883 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of patients undergoing autologous stem cell transplant
Arm/Group Title All Patients
Hide Arm/Group Description:
Ara-C Mitoxantrone Etoposide
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: Days
367 [1] 
(95 to NA)
[1]
Largest observation censored at 883 days
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Ara-C Mitoxantrone Etoposide
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   7/32 (21.88%)    
Gastrointestinal disorders   
Hemorrhage  [1]  1/32 (3.13%)  1
General disorders   
Hemorrhage  [2]  1/32 (3.13%)  1
Sudden death *  1/32 (3.13%)  1
Infections and infestations   
Neutropenic fever  [3]  1/32 (3.13%)  1
Infection with grade 4 neutrophils   3/32 (9.38%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Grade 4
[2]
One intra cranial (grade 5)
[3]
Grade 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   31/32 (96.88%)    
Blood and lymphatic system disorders   
Thrombocytopenia  [1]  8/32 (25.00%) 
Cardiac disorders   
Left ventrcular dysfunction  [1]  4/32 (12.50%) 
Hypotension   4/32 (12.50%) 
Tachycardia   2/32 (6.25%) 
Atrial fibrillation   2/32 (6.25%) 
Gastrointestinal disorders   
Non-infectious diarrhea  [1]  8/32 (25.00%) 
General disorders   
Anemia  [1]  3/32 (9.38%) 
Mental status changes   2/32 (6.25%) 
Infections and infestations   
Neutropenic fever  [1]  19/32 (59.38%) 
Infection/sepsis  [1]  16/32 (50.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia   3/32 (9.38%) 
Respiratory failure   2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
Rash   10/32 (31.25%) 
Indicates events were collected by systematic assessment
[1]
Grade 3-4
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Lucy A. Godley
Organization: University of Chicago
Phone: 773-702-4140
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
First Submitted: October 15, 2008
First Posted: October 16, 2008
Results First Submitted: December 17, 2012
Results First Posted: June 24, 2013
Last Update Posted: February 11, 2014