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Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00429026
Recruitment Status : Terminated (Slow accrual, study terminated.)
First Posted : January 31, 2007
Results First Posted : July 13, 2009
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Cancer
Interventions Drug: Fludarabine
Drug: Melphalan
Drug: Cyclophosphamide
Procedure: Stem Cell Transplant
Enrollment 40
Recruitment Details Enrollment Period: January 16, 2004 through March 29, 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.
Pre-assignment Details Only 5 patients received allogeneic stem cell transplantation while 35 received standard chemotherapy. Study terminated due to low patient accrual. This population was not analyzed by treatment arm on this study.
Arm/Group Title Conditioning Regimen
Hide Arm/Group Description Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Period Title: Overall Study
Started 40
Completed 0
Not Completed 40
Reason Not Completed
Inevaluable for response.             40
Arm/Group Title Conditioning Regimen
Hide Arm/Group Description Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
48
(30 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
11
  27.5%
Male
29
  72.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Survival Rate
Hide Description Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.
Arm/Group Title Conditioning Regimen
Hide Arm/Group Description:
Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years and 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conditioning Regimen
Hide Arm/Group Description Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
All-Cause Mortality
Conditioning Regimen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conditioning Regimen
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conditioning Regimen
Affected / at Risk (%)
Total   5/40 (12.50%) 
Gastrointestinal disorders   
Nausea  1  5/40 (12.50%) 
Vomiting  1  5/40 (12.50%) 
Diarrhea  1  5/40 (12.50%) 
General disorders   
Fatigue  1  5/40 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.
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: Naoto Ueno, MD, PhD / Associate Professor
Organization: U.T. M.D. Anderson Cancer Center
Phone: 713-792-8754
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429026     History of Changes
Other Study ID Numbers: 2003-0364
First Submitted: January 29, 2007
First Posted: January 31, 2007
Results First Submitted: February 26, 2009
Results First Posted: July 13, 2009
Last Update Posted: March 4, 2013