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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: Plerixafor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>0.24 mg/kg plerixafor on day 1 | Drug: Plerixafor<br>* 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.<br>* Other names: Mozobil;|
| Experimental: Cohort B<br>0.24 mg/kg plerixafor daily on days 1 & 2 | Drug: Plerixafor<br>* 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.<br>* Other names: Mozobil;|
| No Intervention: Cohort C<br>Six control subjects will have research bloods drawn but receive no plerixafor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours before high dose chemotherapy |