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Trial record 51 of 52 for:    "Acute Leukemia" | "Anti-Bacterial Agents"

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

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ClinicalTrials.gov Identifier: NCT01135329
Recruitment Status : Terminated (The stopping rule was met and hence the study was closed)
First Posted : June 2, 2010
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Leukemia
Myelodysplastic Syndrome
Interventions Drug: Fludarabine
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil
Drug: Tacrolimus
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
49
(3 to 73)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
1
   6.7%
Between 18 and 65 years
12
  80.0%
>=65 years
2
  13.3%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Female 6
Male 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Chimerism in Unsorted Peripheral Blood
Hide Description Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
Time Frame Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Chimerism in CD3+ Sorted Peripheral Blood
Hide Description Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood
Time Frame Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Percentage of participants alive
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-free Survival
Hide Description Percentage of participants alive without disease relapse or progression.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Incidence of Relapse
Hide Description Percentage of participants experiencing disease relapse or progression
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Non-relapse Mortality
Hide Description Percentage of participants who died due to BMT-related reasons
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title BMT Allogenic Transplantation
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Incidence of Graft-versus-host-disease (GVHD)
Hide Description Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Arm/Group Title Transplant
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Graft Failure
Hide Description Percentage of participants who failed to engraft.
Time Frame Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant
Hide Arm/Group Description:
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
8
  53.3%
Time Frame 1 year
Adverse Event Reporting Description Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
 
Arm/Group Title Transplant
Hide Arm/Group Description Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
All-Cause Mortality
Transplant
Affected / at Risk (%)
Total   9/15 (60.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Transplant
Affected / at Risk (%) # Events
Total   11/15 (73.33%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Diarrhea  1  1/15 (6.67%)  1
General disorders   
Fever  1  2/15 (13.33%)  2
Chills  1  1/15 (6.67%)  1
Infections and infestations   
Infection  1  7/15 (46.67%)  7
Sepsis  1  2/15 (13.33%)  2
Metabolism and nutrition disorders   
Dehydration  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  1/15 (6.67%)  1
Respiratory failure  1  1/15 (6.67%)  1
1
Term from vocabulary, CTCAE (4.0)
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 0%
Transplant
Affected / at Risk (%) # Events
Total   7/15 (46.67%)    
Gastrointestinal disorders   
nausea  1  1/15 (6.67%)  2
General disorders   
fever  1  1/15 (6.67%)  1
Infections and infestations   
Infection  1  4/15 (26.67%)  4
Febrile neutropenia  1  4/15 (26.67%)  4
Investigations   
Elevated liver enzymes  1  1/15 (6.67%)  1
Elevated total bilirubin  1  1/15 (6.67%)  1
Nervous system disorders   
tremor  1  1/15 (6.67%)  1
Psychiatric disorders   
hallucinations  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  2/15 (13.33%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Yvette Kasamon
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8839
EMail: ykasamo1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01135329     History of Changes
Other Study ID Numbers: J1046
NA_00039363 ( Other Identifier: JHM IRB )
First Submitted: June 1, 2010
First Posted: June 2, 2010
Results First Submitted: August 22, 2014
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018