Clinical trial · Interventional
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding withdrawal
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored. PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies
Conditions
Conditions (83)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Filgrastim and plerixafor for PBSC mobilization
- description
- Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation.
- interventionNames
- Drug: plerixafor
- Biological: filgrastim
- Procedure: peripheral blood stem cell transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
Primary outcomes (1)
- measure
- Successful Collection of Stem Cells
- timeFrame
- At the end of apheresis for cell collection
- description
- Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Hematologic malignancy considered eligible and suitable for allogeneic stem cell transplantation (syngeneic transplantation is acceptable); diagnoses include acute myeloid or lymphoid leukemias, chronic myeloid or lymphoid leukemias, multiple myeloma, lymphoma or myelodysplasia; subjects suitable for this study will primarily receive transplant on a standard treatment plan (non research regimen) * Organ function, performance status and age suitable for an ablative regimen consisting of TBI \>= 10Gy or a chemotherapy regimen consisting of busulphan and cyclophosphamide (BuCY) or busulphan and melphalan (BuMel) * Availability of a fully matched sibling donor * Ability to understand and willingness to sign an informed consent * No uncontrolled infections * DONOR: Human leukocyte antigen (HLA) identical sibling donor * DONOR: \>= 18 years * DONOR: No unacceptable risk to donor due to pre-existing illness * DONOR: Must have suitable antecubital veins for leukapheresis venipuncture; donors who will require a temporary, Mahurkar-type catheter are not eligible * DONOR: Ability and willingness to sign an informed consent document Exclusion Criteria: * Eligible for and willingness to participate in any research study of transplant regimens * Eligible for and willingness to participate in a non ablative transplant regimen * Human immunodeficiency virus (HIV) seropositive * Pregnancy * DONOR: HIV seropositive * DONOR: Contraindication or hypersensitivity to filgrastim or plerixafor * DONOR: Hepatitis A, B, C seropositive * DONOR: Pregnant or lactating females * DONOR: Liver function studies \> 2 times the upper limit of normal (ULN) at evaluation, Creatinine \> 2, pulmonary function diffusing lung capacity for carbon monoxide (DLCO) \< 50% (if specifically evaluated), cardiac ejection fraction \< 50% (if specifically evaluated) * DONOR: Any known ventricular arrhythmia
References
Publications (0)
Data not yet available