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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Tufts Medical Center
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01610999
First received: March 16, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Lymphoma
Multiple Myeloma
Drug: Plerixafor
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

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. [ Time Frame: 2 hours before high dose chemotherapy ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 16
Study Start Date: July 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mozobil
No Intervention: Cohort C
Six "control" subjects will have research bloods drawn but receive no plerixafor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610999

Contacts
Contact: Jodi Jensen, RN, BSN 617-636-5558 jjensen@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Jodi Jensen, RN, BSN    617-636-5558    jjensen@tuftsmedicalcenter.org   
Principal Investigator: Andreas K Klein, MD         
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Andreas K Klein, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01610999     History of Changes
Other Study ID Numbers: Plerixafor
Study First Received: March 16, 2012
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014