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Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00990249
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Allogeneic Haematopoietic Stem Cell Transplantation
Acute Lymphoblastic Leukemia
Interventions: Drug: Busulfan
Drug: Clofarabine
Drug: Thymoglobulin
Procedure: Stem Cell Transplant

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: October 01, 2009 to July 13, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Busulfan + Clofarabine + Stem Cell Transplant Busulfan test dose 32 mg/m^2 intravenous (IV) Day -8; following doses Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.

Participant Flow:   Overall Study
    Busulfan + Clofarabine + Stem Cell Transplant
STARTED   120 
COMPLETED   107 
NOT COMPLETED   13 
Disease Progression                8 
Non-Compliance                1 
Death                2 
Not treated                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Busulfan + Clofarabine + Stem Cell Transplant Busulfan test dose 32 mg/m^2 IV Day -8; following doses Days -6 to -3 derived from PK testing. Clofarabine 40 mg/m^2 IV daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg Day -3, 1.5 mg/kg Day -2 & 2.0 mg/kg Day -1 for HLA nonidentical or unrelated donors. Stem cell infusion on Day 0.

Baseline Measures
   Busulfan + Clofarabine + Stem Cell Transplant 
Overall Participants Analyzed 
[Units: Participants]
 120 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      3   2.5% 
Between 18 and 65 years      117  97.5% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 38 
 (12 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      47  39.2% 
Male      73  60.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      14  11.7% 
Not Hispanic or Latino      86  71.7% 
Unknown or Not Reported      20  16.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      8   6.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   0.8% 
White      91  75.8% 
More than one race      8   6.7% 
Unknown or Not Reported      12  10.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   120 


  Outcome Measures

1.  Primary:   Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM)   [ Time Frame: 100 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Partow Kebriaei, MD/Professor, Stem Cell Transplantation
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00990249     History of Changes
Other Study ID Numbers: 2009-0209
NCI-2012-01270 ( Registry Identifier: NCI CTRP )
First Submitted: October 2, 2009
First Posted: October 6, 2009
Results First Submitted: May 26, 2017
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018