Clinical trial · Interventional
Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection
Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection
NCT01042717CI-TRIAL-00005551unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Plerixafor
- description
- Plerixafor 16 hours
- interventionNames
- Drug: Plerixafor
Primary outcomes (1)
- measure
- Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
- timeFrame
- After collection
Secondary outcomes (2)
- measure
- Median and average neutrophil and platelet engraftment
- timeFrame
- After stem cell infusion
- measure
- Plerixafor-related toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral blood stem cell collection as part of standard clinical care. Biopsy-confirmed diagnosis of NHL or MM is to have been done prior to the first mobilization. 2. In first or second CR or PR 3. ECOG performance status of 0 or 1 4. WBC count greater than 2.5 x 10e9/1 5. Absolute PMN count greater than 1.5 x 10e9/1 6. PLT count greater than 100 x 10e9/1 7. Serum creatinine less than or equal to 2.2 mg/dl 8. SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN) 9. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation 10. Negative for HIV 11. 4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study) 12. Patients of childbearing potential agree to use an approved form of contraception 13. Recovered from all acute toxic effects of prior chemotherapy Exclusion Criteria: 1. Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications 2. Failed previous stem cell collections or collection attempts 3. Less than 6 weeks of carmustine prior to the 1st dose of G-CSF 4. Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization 5. Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization 6. Active CNS involvement 7. Active brain metastases or carcinomatous meningitis 8. Bone marrow involvement greater than 20 percent 9. Received radiation therapy to the pelvis 10. Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated 11. Received prior radio-immunotherapy with Zevalin or Bexxar 12. Fever (temperature greater than 38 C/100.4 F) 13. Received bone-seeking radionuclides (e.g., holmium) 14. A residual acute medical condition resulting from prior chemotherapy 15. Active brain metastases or myelomatous meningitis 16. Received thalidomide, dexamethasone and/or Velcade within 7 days prior to the first dose of G-CSF 17. Received Revlimid within 3 weeks prior to the first dose of G-CSF 18. Received greater than 6 cycles of Revlimid 19. Positive pregnancy test or lactating 20. Active infection requiring antibiotic treatment 21. Abnormal ECG with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial. 22. Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase. 23. Patients whose apheresis product will be further selected and purified. 24. Prior autologous or allogeneic transplant.
References
Publications (2)
- BACKGROUNDLiles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x. PMID 15752146
- BACKGROUNDDiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31. PMID 19720922