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Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi-Bin A. Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01643668
First received: June 12, 2012
Last updated: June 14, 2017
Last verified: June 2017
Results First Received: May 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Interventions: Drug: Busulfan
Drug: Clofarabine
Procedure: Allogeneic Stem Cell Infusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BuClo RIC + SCT

BuClo RIC SCT

Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation

Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation

Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy


Participant Flow:   Overall Study
    BuClo RIC + SCT
STARTED   34 
COMPLETED   33 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
BuClo RIC + SCT

BuClo RIC SCT

Busulfan: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation

Clofarabine: Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation

Allogeneic Stem Cell Infusion: Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy


Baseline Measures
   BuClo RIC + SCT 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 34 
   63.5 
 (25 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 34 
Female      9  26.5% 
Male      25  73.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 34 
United States   34 
Diagnosis 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 34 
Acute Myeloid Leukemia (AML)      25  73.5% 
Myelodysplastic Syndrome (MDS)      5  14.7% 
Acute Lymphoblastic Leukemia (ALL)      4  11.8% 
Hematopoietic Cell Transplantation (HCT) Refined Disease Risk Index (DRI) [1] 
[Units: Participants]
Count of Participants
 
Low   
Participants Analyzed 
[Units: Participants]
 34 
Low   1 
Intermediate   
Participants Analyzed 
[Units: Participants]
 34 
Intermediate   27 
High   
Participants Analyzed 
[Units: Participants]
 34 
High   6 
[1] Categorization of disease risk determined by the Refined Disease Risk Index (DRI) for patients receiving Hematopoietic Cell Transplantation (HCT).
Disease Stage [1] 
[Units: Participants]
Count of Participants
 
First Complete Remission (CR1)   
Participants Analyzed 
[Units: Participants]
 34 
First Complete Remission (CR1)   25 
Second Complete Remission (CR2)   
Participants Analyzed 
[Units: Participants]
 34 
Second Complete Remission (CR2)   6 
Partial remission/active disease/blasts >5%   
Participants Analyzed 
[Units: Participants]
 34 
Partial remission/active disease/blasts >5%   3 
[1]

Disease stage at time of treatment:

  • CR1: Absence of disease following initial treatment
  • CR2: Complete remission occurs achieved following progression of disease after initial complete remission
  • Partial remission/active disease/ blasts >5%: participants who are not currently in remission
Cytogenics for patients with AML/MDS [1] [2] 
[Units: Participants]
Count of Participants
 
Favorable   
Participants Analyzed 
[Units: Participants]
 30 
Favorable   1 
Intermediate   
Participants Analyzed 
[Units: Participants]
 30 
Intermediate   24 
Adverse   
Participants Analyzed 
[Units: Participants]
 30 
Adverse   5 
[1] Southwest Oncology Group Risk Stratification
[2] The 30 participants diagnosed with ALL or MDS
ALL Cytogenics [1] 
[Units: Participants]
Count of Participants
 
Philadelphia Chromosome   
Participants Analyzed 
[Units: Participants]
 4 
Philadelphia Chromosome   2 
Other   
Participants Analyzed 
[Units: Participants]
 4 
Other   2 
[1] The four participants diagnosed with ALL
Hematopoietic cell transplantation specific comorbidity index (HCT-CI) [1] 
[Units: Units on a scale]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 34 
   1 
 (0 to 9) 
[1] The HTC-CI provides information about the overall and non-relapse mortality risk a patient is likely to experience following a hematopoietic cell transplantation. Lower scores represent lower risk and higher scores represent higher risk. The score is produced by adding up the number of specific risk factors a patient has and can range from 0 to 26. The index is usually characterized as risk categories from 0 to 4+ with patients with four or more risk factors considered high risk.
Donor Type [1] 
[Units: Participants]
Count of Participants
 
Matched Related   
Participants Analyzed 
[Units: Participants]
 34 
Matched Related   11 
Matched Unrelated   
Participants Analyzed 
[Units: Participants]
 34 
Matched Unrelated   23 
[1] Matched = Human Leukocyte Antigen (HLA) matched; Related = donor and recipient are genetic relatives
Cytomegalovirus Serostatus 
[Units: Participants]
Count of Participants
 
Either donor or host positive for virus   
Participants Analyzed 
[Units: Participants]
 34 
Either donor or host positive for virus   22 
Both negative for virus   
Participants Analyzed 
[Units: Participants]
 34 
Both negative for virus   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of Donor Stem Cell Engraftment: ANC Count   [ Time Frame: 1, 2, 3, and 4 weeks after transplantation ]

2.  Primary:   Donor Stem Cell Engraftment: Platelet Count   [ Time Frame: 1, 2, 3, 4, 8, and 14 weeks post transplant ]

3.  Secondary:   Cumulative Incidence of Non-relapse Mortality   [ Time Frame: 100 days, 1 year ]

4.  Secondary:   Progression-Free and Overall Survival   [ Time Frame: 1 year, 2 years ]

5.  Secondary:   Cumulative Incidence and Severity of Acute GVHD Within 100 Days Post Transplant   [ Time Frame: 100 days ]

6.  Secondary:   Cumulative Incidence of Chronic GVHD at One Year   [ Time Frame: 1 year ]

7.  Secondary:   Incidence of Hepatic Veno-occlusive Disease   [ Time Frame: 2 years ]

8.  Secondary:   Grade 3 or 4 Toxicities   [ Time Frame: 2 years ]

9.  Secondary:   Infection-related Complications   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Yi-Bin Chen, MD
Organization: Massachusetts General Hospital
phone: 617-726-0187
e-mail: YCHEN6@PARTNERS.ORG



Responsible Party: Yi-Bin A. Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01643668     History of Changes
Other Study ID Numbers: 12-128
Study First Received: June 12, 2012
Results First Received: May 15, 2017
Last Updated: June 14, 2017