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Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00255684
Recruitment Status : Terminated (low accrual)
First Posted : November 21, 2005
Results First Posted : June 27, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
University of Rochester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions Biological: graft-versus-tumor induction therapy
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: umbilical cord blood transplantation
Radiation: radiation therapy
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conditioning Therapy Followed by TBI
Hide Arm/Group Description

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

graft-versus-tumor prophylaxis therapy

cyclophosphamide

cyclosporine

fludarabine phosphate

mycophenolate mofetil

umbilical cord blood transplantation

radiation therapy

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Conditioning Therapy Followed by TBI
Hide Arm/Group Description

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

graft-versus-tumor prophylaxis therapy

cyclophosphamide

cyclosporine

fludarabine phosphate

mycophenolate mofetil

umbilical cord blood transplantation

radiation therapy

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
2
  12.5%
Between 18 and 65 years
14
  87.5%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Number of Participants Who Survived 100 Days or Longer
Hide Description [Not Specified]
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conditioning Therapy Followed by TBI
Hide Arm/Group Description:

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

graft-versus-tumor prophylaxis therapy

cyclophosphamide

cyclosporine

fludarabine phosphate

mycophenolate mofetil

umbilical cord blood transplantation

radiation therapy

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
13
2.Secondary Outcome
Title Number of Participants Who Developed Acute Graft Versus Host Disease
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conditioning Therapy Followed by TBI
Hide Arm/Group Description:

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

graft-versus-tumor prophylaxis therapy

cyclophosphamide

cyclosporine

fludarabine phosphate

mycophenolate mofetil

umbilical cord blood transplantation

radiation therapy

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conditioning Therapy Followed by TBI
Hide Arm/Group Description

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

graft-versus-tumor prophylaxis therapy

cyclophosphamide

cyclosporine

fludarabine phosphate

mycophenolate mofetil

umbilical cord blood transplantation

radiation therapy

All-Cause Mortality
Conditioning Therapy Followed by TBI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conditioning Therapy Followed by TBI
Affected / at Risk (%)
Total   11/16 (68.75%) 
General disorders   
multi-organ failure *  2/16 (12.50%) 
relapsed transplant resulting in death *  4/16 (25.00%) 
Immune system disorders   
graft versus host disease *  3/16 (18.75%) 
Post-transplant lymphoproliferative disorder *  1/16 (6.25%) 
Infections and infestations   
sepsis *  3/16 (18.75%) 
Metabolism and nutrition disorders   
Syndrome of Inappropriate Antidiuretic Hormone Secretion *  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conditioning Therapy Followed by TBI
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Gordon L. Phillips
Organization: Wake Forest
Phone: 604.875.4111 ext 67806
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00255684     History of Changes
Other Study ID Numbers: CDR0000448637
URCC-U19403
URCC-RSRB-10063
First Submitted: November 18, 2005
First Posted: November 21, 2005
Results First Submitted: May 18, 2016
Results First Posted: June 27, 2016
Last Update Posted: November 3, 2016