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

Tufts University

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma; Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Plerixafor

Study type: Interventional

Funder types: Other

Identifiers

NCT01610999

Plerixafor

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7 participants in 3 patient groups

Cohort A

Experimental group

Description:

0.24 mg/kg plerixafor on day 1

Treatment:

Drug: Plerixafor

Cohort B

Experimental group

Description:

0.24 mg/kg plerixafor daily on days 1 \& 2

Treatment:

Drug: Plerixafor

Cohort C

No Intervention group

Description:

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