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

NCT01610999 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: Plerixafor
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Cohort A

EXPERIMENTAL

0.24 mg/kg plerixafor on day 1

Drug: Plerixafor

Cohort B

EXPERIMENTAL

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

Drug: Plerixafor

Cohort C

NO INTERVENTION

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

Interventions

Plerixafor 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.

Also known as: Mozobil

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Multiple Myeloma

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Andreas K Klein, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: June 4, 2012
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)