Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
This study is not yet open for participant recruitment.
Verified December 2012 by Tufts Medical Center
Sponsor:
Tufts Medical Center
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01610999
First received: March 16, 2012
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia Lymphoma Multiple Myeloma |
Drug: Plerixafor |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation |
Resource links provided by NLM:
Further study details as provided by Tufts Medical Center:
Primary Outcome Measures:
- 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. [ Time Frame: 2 hours before high dose chemotherapy ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 16 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort A
0.24 mg/kg day 1
|
Drug: 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.
Other Name: Mozobil
|
|
Experimental: Cohort B
0.24 mg/kg daily, day 1 & 2
|
Drug: 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.
Other Name: Mozobil
|
|
No Intervention: Cohort C
Six "control" subjects will have research bloods drawn but receive no plerixafor.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610999
Contacts
| Contact: Jodi Jensen, RN, BSN | 617-636-5558 | jjensen@tuftsmedicalcenter.org |
Locations
| United States, Massachusetts | |
| Tufts Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Jodi Jensen, RN, BSN 617-636-5558 jjensen@tuftsmedicalcenter.org | |
| Principal Investigator: Andreas K Klein, MD | |
Sponsors and Collaborators
Tufts Medical Center
Investigators
| Principal Investigator: | Andreas K Klein, MD | Tufts Medical Center |
More Information
No publications provided
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT01610999 History of Changes |
| Other Study ID Numbers: | Plerixafor |
| Study First Received: | March 16, 2012 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders JM 3100 Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013