Clinical trial · Observational
Feasibility and Efficiency Study of Leukemic Cell Mobilization With Plerixafor Injection
Mobilization of Leukemic Cells Using Plerixafor as Part of a Myeloablative Preparative Regimen for Patients With AML Undergoing Allografting: Assessment of Feasibility and Efficacy
- 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 study will be conducted as a single center Phase I/II study to evaluate the safety of administering Plerixafor administered as part of a myeloablative preparative regimen (Institutional Protocol:Fludarabine 50mg/m2/da x 4 days, Busulfan 3.2mg/kg/day x 4 days, TBI 400cGy in divided fractions) for stem cell transplant recipients with AML and to determine whether or not residual leukemic stem cells can be mobilized. Three patients will be enrolled into each of 4 sequential cohorts. Patients in the first cohort will receive 1 dose of Plerixafor (240mcg/kg sc) prior to administration of the first dose of Fludarabine and Busulfan. If tolerated it is planned to escalate the number of Plerixafor doses in the subsequent cohorts to 2. 3. and 4 to be administered before the respective 2nd, 3rd, and 4th dose of chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor (mozobil) | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- cohort 1
- description
- Patients in Cohort 1 will be followed with daily Flowcytometric studies to quantify CXCR4 positive cells.The samples will be obtained before the following doses of FLUDARABINE and BUSULFAN. Eighteen hrs (range 18 -20 hrs) after start of the last dose of FUDARABINE andBUSULFAN and before the first dose of TBI a PB sample as well as bone marrow aspirate and biopsy will be obtained to repeat the studies as conducted prior to the first dose of PLERIXAFOR
- interventionNames
- Drug: Plerixafor (mozobil)
- label
- Cohort 2
- description
- Patients in Cohort 2 will receive the second dose of PLERIXAFOR 24 hrs after the first dose. A PB sample for a CBS and Flowcytometry will be drawn prior to the dose. Nine hrs later a further study sample for Flowcytometry will be obtained prior to administration of the second dose of FLUARABINE and BUSULFAN. Flowcytometric studies will be repeated on day 3 and 4. Eighteen hrs (range 18 - 20 hrs) after start of the last dose of FLUDARABINE and BUSULFAN and before the first dose of TBI a PB sample as well as bone marrow aspirate and biopsy will be obtained to repeat the studies as conducted prior to the first dose of PLERIXAFOR.
- interventionNames
- Drug: Plerixafor (mozobil)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with AML in remission. * Availability of a suitably matched related or unrelated donor * Age 18-60 years * Eligibility for a myeloablative transplant using the Institutional protocols R-FBT(400)-CSMF as preparative regimen for related donors and U-FBT(400)-CP(30)CS for unrelated donors. * Eligible subjects who are illiterate will be offered participation in the study Exclusion criteria: * Patients aged 61years or older * Patients not eligible for the preparative regimens R-FBT(400)-CSMF or U-FBT(400)-CP(30)CS * Pregnant or lactating females * Creatinine of .\>2x normal * Bilirubin, AST, ALT \> 2x normal * MUGA of \<50%
References
Publications (1)
- DERIVEDMichelis FV, Hedley DW, Malhotra S, Chow S, Loach D, Gupta V, Kim DD, Kuruvilla J, Lipton JH, Viswabandya A, Messner HA. Mobilization of Leukemic Cells Using Plerixafor as Part of a Myeloablative Preparative Regimen for Patients with Acute Myelogenous Leukemia Undergoing Allografting: Assessment of Safety and Tolerability. Biol Blood Marrow Transplant. 2019 Jun;25(6):1158-1163. doi: 10.1016/j.bbmt.2019.01.014. Epub 2019 Jan 14. PMID 30654137