Back to resultsClofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Primary Purpose
Advanced Hematologic Malignancies, Leukemia, Preleukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clofarabine
Melphalan
Campath
Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hematologic Malignancies focused on measuring Melphalan, Alemtuzumab, Clofarabine
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory acute myelogenous or lymphoid leukemia
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
- Myelodysplastic syndromes (including PNH) with > 5% blasts
- Zubroid performance status < 2 (See Appendix B)
- Life expectancy is not severely limited by concomitant illness
- Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
- Calculated Creatinine Clearance > 50 ml/min
- Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
- No evidence of chronic active hepatitis or cirrhosis
- HIV-negative
- Patient is not pregnant
- Patient or guardian able to sign informed consent
Exclusion Criteria:
- Clinical progression
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Toxicity was scored according to NCI/CTC version 3
Secondary Outcome Measures
Overall Survival (OS)
Progression-free Survival (PFS)
Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.
Treatment-related Mortality (TRM)
Relapse Rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00943592
Brief Title
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Official Title
Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hematologic Malignancies, Leukemia, Preleukemia
Keywords
Melphalan, Alemtuzumab, Clofarabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Intervention Description
Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Doses ranging from 100 to 140 mg/m2
Intervention Type
Drug
Intervention Name(s)
Campath
Intervention Description
20mg/d x5
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplant
Intervention Description
Infusion of donor, bone marrow and auto.
Primary Outcome Measure Information:
Title
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Description
Toxicity was scored according to NCI/CTC version 3
Time Frame
Day 7 until Day 30
Title
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Description
Toxicity was scored according to NCI/CTC version 3
Time Frame
Day 7 until Day 30
Title
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Description
Toxicity was scored according to NCI/CTC version 3
Time Frame
Day 7 until Day 30
Title
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
Description
Toxicity was scored according to NCI/CTC version 3
Time Frame
Day 7 until Day 30
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
1 year
Title
Progression-free Survival (PFS)
Description
Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.
Time Frame
1 year
Title
Treatment-related Mortality (TRM)
Time Frame
1 year
Title
Relapse Rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory acute myelogenous or lymphoid leukemia
Chronic myelogenous leukemia in accelerated phase or blast-crisis
Chronic myelogenous leukemia in second or subsequent chronic phase
Recurrent or refractory malignant lymphoma or Hodgkin's disease
Multiple myeloma at high risk for disease recurrence
Chronic lymphocytic leukemia, relapsed or with poor prognostic features
Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
Myelodysplastic syndromes (including PNH) with > 5% blasts
Zubroid performance status < 2 (See Appendix B)
Life expectancy is not severely limited by concomitant illness
Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
Calculated Creatinine Clearance > 50 ml/min
Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
No evidence of chronic active hepatitis or cirrhosis
HIV-negative
Patient is not pregnant
Patient or guardian able to sign informed consent
Exclusion Criteria:
Clinical progression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Artz, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
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