Back to resultsPilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Primary Purpose
Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Plerixafor
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Subjects must have documented, relapsed/refractory or high-risk primary lymphoid malignancy
- Subjects must have evidence of residual disease prior to transplant, but need not have measurable or strictly evaluable disease
- Subjects must be eligible candidates for high dose chemotherapy with either BEAM or single-agent melphalan preparative regimens and autologous stem cell transplantation at Tufts Medical Center (See Appendix B for anticipated transplant schedules)
- Subjects must be able to provide informed consent to the research procedure
Exclusion Criteria:
- Uncontrolled infection
- Active heart disease as evidenced by myocardial infarction within 6 months, uncontrolled arrhythmia, or angina.
- Creatinine clearance estimated < 50 ml/min.
- HIV infection or evidence of active chronic hepatitis
- Unable or unwilling to comply with required study procedures
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cohort A
Cohort B
Cohort C
Arm Description
0.24 mg/kg plerixafor on day 1
0.24 mg/kg plerixafor daily on days 1 & 2
Six "control" subjects will have research bloods drawn but receive no plerixafor.
Outcomes
Primary Outcome Measures
The rate of grade 2 or greater adverse events related to study participation will be compared to historical controls matched for diagnosis and chemotherapy regimen.
Confirm the safety of the addition of plerixafor as a single dose or as a two-day dose commencing 2 hours before the high dose chemotherapy regimen prior to autologous stem cell transplantation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01610999
Brief Title
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Official Title
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Unavailability of study article
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In order to keep our immune systems healthy over our lifetime, certain cells in the bone marrow and lymph nodes called stromal cells nurture the immune cells and protect them from damage. Stromal cells and blood cells communicate using a protein called SDF1a. The investigators think that cancer cells including lymphoma and multiple myeloma can trick the stromal cells into helping them avoid damage from chemotherapy by using SDF1a.
Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the bone marrow for use in transplantation. The use of plerixafor to interrupt communication between stromal cells and cancer has not been approved by the FDA and is experimental.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
0.24 mg/kg plerixafor on day 1
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
0.24 mg/kg plerixafor daily on days 1 & 2
Arm Title
Cohort C
Arm Type
No Intervention
Arm Description
Six "control" subjects will have research bloods drawn but receive no plerixafor.
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil
Intervention Description
Plerixafor will be dosed according to actual body weight. Each dose will be capped at 24 mg (single vial). Plerixafor will be administered subcutaneously according to the assigned cohort starting two hours before the scheduled start of high dose chemotherapy.
Primary Outcome Measure Information:
Title
The rate of grade 2 or greater adverse events related to study participation will be compared to historical controls matched for diagnosis and chemotherapy regimen.
Description
Confirm the safety of the addition of plerixafor as a single dose or as a two-day dose commencing 2 hours before the high dose chemotherapy regimen prior to autologous stem cell transplantation.
Time Frame
2 hours before high dose chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Subjects must have documented, relapsed/refractory or high-risk primary lymphoid malignancy
Subjects must have evidence of residual disease prior to transplant, but need not have measurable or strictly evaluable disease
Subjects must be eligible candidates for high dose chemotherapy with either BEAM or single-agent melphalan preparative regimens and autologous stem cell transplantation at Tufts Medical Center (See Appendix B for anticipated transplant schedules)
Subjects must be able to provide informed consent to the research procedure
Exclusion Criteria:
Uncontrolled infection
Active heart disease as evidenced by myocardial infarction within 6 months, uncontrolled arrhythmia, or angina.
Creatinine clearance estimated < 50 ml/min.
HIV infection or evidence of active chronic hepatitis
Unable or unwilling to comply with required study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas K Klein, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
We'll reach out to this number within 24 hrs