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

Phase 1

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Lymphoma; Multiple Myeloma
• Interventions: Drug: Plerixafor

• Registration Number: NCT01610999
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Study Start: 2013-07
• Primary Completion: 2014-06
• Study Completion: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Plerixafor	0.24 mg/kg plerixafor on day 1
Cohort B	Plerixafor	0.24 mg/kg plerixafor daily on days 1 \& 2

Primary Outcome Measures

Name	Time	Method
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.	2 hours before high dose chemotherapy	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.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States