Back to resultsT-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Primary Purpose
Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Melphalan
Stem cells
Campath
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy., Myelodysplastic syndromes (including PNH), Multiple myeloma at high risk for disease recurrence.
Eligibility Criteria
Inclusion Criteria:
- Zubrod 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.
- Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
- Serum bilirubin 2.0 mg/dl, SGPT <3 x 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:
- N/A
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug Intervention
Arm Description
Outcomes
Primary Outcome Measures
Median Disease-free Survival
All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3
Secondary Outcome Measures
Median Overall Survival
All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00683046
Brief Title
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Official Title
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
Objectives:
To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia, Myeloproliferative Disorder, Anemia, Aplastic, Myelodysplastic Syndromes
Keywords
Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy., Myelodysplastic syndromes (including PNH), Multiple myeloma at high risk for disease recurrence.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Melphalan 140 mg/m2 IV on day -2.
Intervention Type
Drug
Intervention Name(s)
Stem cells
Intervention Description
Stem cell infusion on day 0.
Intervention Type
Drug
Intervention Name(s)
Campath
Intervention Description
Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
Primary Outcome Measure Information:
Title
Median Disease-free Survival
Description
All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3
Time Frame
Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
Secondary Outcome Measure Information:
Title
Median Overall Survival
Description
All patients were administered the following drugs;
Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
Melphalan 140mg/m2 IV on day -2
Stem cell infusion on day 0
Campath 20mg IV on day -7,-6,-5,-4, and -3
Time Frame
Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Zubrod 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.
Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
Serum bilirubin 2.0 mg/dl, SGPT <3 x 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:
N/A
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
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
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