Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00943592
First received: July 20, 2009
Last updated: January 9, 2014
Last verified: January 2014
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Advanced Hematologic Malignancies
Leukemia
Preleukemia
Interventions: Drug: Clofarabine
Drug: Melphalan
Drug: Campath
Procedure: Stem Cell Transplant

  Participant Flow
  Hide Participant Flow

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
Clofarabine, Melphalan, and Alemtuzumab Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.

Participant Flow:   Overall Study
    Clofarabine, Melphalan, and Alemtuzumab  
STARTED     82  
Maximum Tolerated Dose     74 [1]
COMPLETED     79 [2]
NOT COMPLETED     3  
Death                 3  
[1] 74 patients received the Maximum Tolerated Dose
[2] None of the three deaths were attributed to the conditioning regimen



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Clofarabine, Melphalan, and Alemtuzumab Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.

Baseline Measures
    Clofarabine, Melphalan, and Alemtuzumab  
Number of Participants  
[units: participants]
  82  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 21 to 73 )  
Gender  
[units: participants]
 
Female     33  
Male     49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation   [ Time Frame: Day 7 until Day 30 ]

2.  Primary:   Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation   [ Time Frame: Day 7 until Day 30 ]

3.  Primary:   Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation   [ Time Frame: Day 7 until Day 30 ]

4.  Primary:   Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation   [ Time Frame: Day 7 until Day 30 ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: 1 year ]

6.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 1 year ]

7.  Secondary:   Treatment-related Mortality (TRM)   [ Time Frame: 1 year ]

8.  Secondary:   Relapse Rate   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Andrew Artz
Organization: University of Chicago
phone: 773-834-8980
e-mail: aartz@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943592     History of Changes
Obsolete Identifiers: NCT00572546
Other Study ID Numbers: 14341B
Study First Received: July 20, 2009
Results First Received: September 17, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board