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

NCT ID: NCT01610999

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Lymphocytic Leukemia; Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

0.24 mg/kg plerixafor on day 1

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: DRUG

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.

Cohort B

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

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: DRUG

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.

Cohort C

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Mozobil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas K Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Plerixafor

Identifier Type: -

Identifier Source: org_study_id