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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome 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.

Outcome Time Frame:

2 hours before high dose chemotherapy

Safety Issue:

Yes

Principal Investigator

Andreas K Klein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center

Authority:

United States: Institutional Review Board

Study ID:

Plerixafor

NCT ID:

NCT01610999

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Tufts Medical Center Boston, Massachusetts  02111