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Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation

Sponsor
Tufts Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01610999
Collaborator
(none)
7
Enrollment
1
Location
3
Arms
29
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A

0.24 mg/kg plerixafor on day 1

Drug: Plerixafor
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.
Other Names:
  • Mozobil

    		•
    Experimental: Cohort B

    0.24 mg/kg plerixafor daily on days 1 & 2

    Drug: Plerixafor
    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.
    Other Names:
  • Mozobil

    		•
    No Intervention: Cohort C

    Six "control" subjects will have research bloods drawn but receive no plerixafor.

    Outcome Measures

    Primary Outcome Measures

    1. 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. [2 hours before high dose chemotherapy]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts Medical Center

    Investigators

    • Principal Investigator: Andreas K Klein, MD, Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT01610999
    Other Study ID Numbers:
    • Plerixafor
    First Posted:
    Jun 4, 2012
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Leukemia, Lymphocytic, Chronic, B-Cell
    Plerixafor

    Study Results

    No Results Posted as of May 9, 2017