Clinical trial · Interventional
Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unavailability of study article
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- 0.24 mg/kg plerixafor on day 1
- interventionNames
- Drug: Plerixafor
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- 0.24 mg/kg plerixafor daily on days 1 \& 2
- interventionNames
- Drug: Plerixafor
- type
- NO_INTERVENTION
- label
- Cohort C
- description
- Six "control" subjects will have research bloods drawn but receive no plerixafor.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available