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Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00134004
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : August 24, 2015
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Period Title: Overall Study
Started 210
Completed 210
Not Completed 0
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 210 participants
52
(1 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
61
  29.0%
Male
149
  71.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 210 participants
210
1.Primary Outcome
Title Transplant-related Mortality
Hide Description Percentage of participants who die for any reason other than recurrence of disease.
Time Frame Cumulative incidence for the entire study, up to 11 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description:
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: percentage of participants
18
2.Primary Outcome
Title Relapse Rate
Hide Description Percentage of participants who experience disease relapse.
Time Frame Cumulative incidence for the entire study, up to 11 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description:
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: percentage of participants
55
3.Primary Outcome
Title Progression-free Survival
Hide Description Percentage of participants who do not experience disease relapse, disease progression, or death.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description:
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: percentage of participants
34
4.Secondary Outcome
Title Graft Failure Rate
Hide Description Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.
Time Frame Cumulative incidence for the entire study, up to 11 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description:
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: percentage of participants
13
5.Secondary Outcome
Title Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation
Hide Description Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description:
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Overall Number of Participants Analyzed 210
Measure Type: Number
Unit of Measure: percentage of participants
9.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mini-haplo BMT
Hide Arm/Group Description Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
All-Cause Mortality
Mini-haplo BMT
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Mini-haplo BMT
Affected / at Risk (%) # Events
Total   20/210 (9.52%)    
Cardiac disorders   
Atrial fibrillation  1  1/210 (0.48%)  1
Gastrointestinal disorders   
Ascites  1  1/210 (0.48%)  1
Cholestasis  1  1/210 (0.48%)  1
GI bleed  1  2/210 (0.95%)  2
Infections and infestations   
Fungemia  1  3/210 (1.43%)  3
Neutropenic fever  1  1/210 (0.48%)  1
Pneumonia  1  5/210 (2.38%)  5
Sepsis  1  6/210 (2.86%)  6
Investigations   
Multi-organ failure  1  1/210 (0.48%)  1
Nervous system disorders   
Altered mental status  1  1/210 (0.48%)  1
Posterior reversible encephalopathy syndrome  1  1/210 (0.48%)  1
Seizure  1  1/210 (0.48%)  1
Renal and urinary disorders   
Acute kidney injury  1  2/210 (0.95%)  2
Renal failure  1  4/210 (1.90%)  4
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/210 (0.48%)  1
Dyspnea  1  1/210 (0.48%)  1
Idiopathic pneumonia syndrome  1  1/210 (0.48%)  1
Pulmonary Vascular Obstructive Disease  1  1/210 (0.48%)  1
Respiratory failure  1  8/210 (3.81%)  8
Vascular disorders   
Subdural hematoma  1  3/210 (1.43%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mini-haplo BMT
Affected / at Risk (%) # Events
Total   11/210 (5.24%)    
Infections and infestations   
Pneumonia  1  11/210 (5.24%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Ephraim Fuchs
Organization: Johns Hopkins University
Phone: 410-419-6479
EMail: fuchsep@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00134004    
Other Study ID Numbers: J0457 CDR0000440990
P01CA015396 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0457 ( Other Identifier: Johns Hopkins SKCCC )
JHOC-04072704
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: June 26, 2015
Results First Posted: August 24, 2015
Last Update Posted: October 6, 2015