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Stem Cell Transplantation for Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00176839
Recruitment Status : Terminated (Replaced by a different study)
First Posted : September 15, 2005
Results First Posted : February 13, 2013
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Lymphocytic, Acute
AML
MDS
Interventions Procedure: Stem Cell Transplant
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Melphalan
Drug: G-CSF
Drug: ATG
Enrollment 11
Recruitment Details The study was offered to patients at the time different treatment options were being discussed in the clinic or in the hospital.
Pre-assignment Details  
Arm/Group Title Treatment Arm
Hide Arm/Group Description Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Treatment Arm
Hide Arm/Group Description Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
9
  81.8%
Between 18 and 65 years
2
  18.2%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
10.3  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   9.1%
White
8
  72.7%
More than one race
0
   0.0%
Unknown or Not Reported
2
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Probability of Long-term Disease-free Survival (DFS)
Hide Description Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Probability of Engraftment
Hide Description Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
10
3.Secondary Outcome
Title Incidence of Acute Graft-versus-host Disease (GVHD)
Hide Description Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Time Frame 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
7
4.Secondary Outcome
Title Incidence Chronic Graft-versus-host Disease (GVHD)
Hide Description Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Incidence of Regimen-related Toxicity 100 Days Post Transplant
Hide Description Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Time Frame 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
3
6.Secondary Outcome
Title Incidence of Relapse
Hide Description Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
2
Time Frame 1 year post transplant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%) # Events
Total   10/11 (90.91%)    
Immune system disorders   
Acute Graft Versus Host Disease   7/11 (63.64%)  7
Graft Failure   1/11 (9.09%)  1
Infections and infestations   
Fungal Infection   1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Failure   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
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: Margaret MacMillan, M.D.
Organization: University of Minnesota Masonic Cancer Center
Phone: 612-626-2778
EMail: macmi002@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00176839     History of Changes
Other Study ID Numbers: 2000LS040
MT2000-12 ( Other Identifier: Blood and Marrow Transplantation Program )
0005M52481 ( Other Identifier: Institutional Review Board, University of Minnesota )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 11, 2013
Results First Posted: February 13, 2013
Last Update Posted: December 5, 2017