Phase 2
Completed N=30
Donor Enhancement With Plerixafor Post Myeloablative Allogeneic Transplant
Failure of Bone Marrow Graft
Source: ClinicalTrials.gov NCT01280955 ↗
Enrolled (actual)
30
Serious AEs
41.4%
Results posted
Nov 2015
Primary outcomePrimary: Time to Neutrophil Recovery — 17 days
Summary
This phase I/II clinical trial will test the safety and the efficacy of post transplant administration of plerixafor in enhancing hematological recovery in humans. Patients who are appropriate candidates for myeloablative allogeneic stem cell transplantation from an HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for enrollment. The investigators plan to enroll a total of 50 patients for this study (30 patients with HLA-matched sibling or matched unrelated donor transplant, and 20 patients with umbilical cord blood transplant). During phase I study, a small number of patients (3-6 patients from each group) will be enrolled to determine the safety of post transplant administration of plerixafor. Patients will receive plerixafor given at 240 µg/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment. Limiting toxicities are defined as primary or secondary graft failure, plerixafor-related severe premature ventricular arrhythmia or death. If safety criteria are met from the investigators phase I study, the investigators will proceed with phase II study to determine the efficacy of post transplant administration of plerixafor in enhancing haematological recovery. The experimental aspect of this study is the use of plerixafor and all other aspects of care will be in line with the standard of care. Both Phase I and Phase II patients will be combined for efficacy analysis, and data collected from this study will be compared with the investigators historical control. The results from this study will set the stage and provide the justification for a larger phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Neutrophil Recovery |
17 | — |
| PRIMARY Time to Platelet Recovery |
18 | — |
| PRIMARY Plerixafor-associated Adverse Events |
1; 1; 2; 1; 1; 3 | — |
| SECONDARY Transplant-related Mortality |
11 | — |
| SECONDARY Absolute Lymphocyte Count at Day 90 |
549 | — |
| SECONDARY IL-12 at Day 30 |
40.7 | — |
| SECONDARY Participants Experiencing Grade II-IV Acute Graft Versus Host Disease |
5; 5 | — |
| SECONDARY CD3+ Cell Count at Day 90 |
655 | — |
| SECONDARY CD4 Cell Count at Day 90 |
180 | — |
| SECONDARY CD8 Cell Count at Day 90 |
172 | — |
| SECONDARY NK Cell Count at Day 90 |
137 | — |
| SECONDARY B Cell Count at Day 90 |
7 | — |
| SECONDARY IFN Gamma at Day 30 |
8.6 | — |
| SECONDARY TNF-alpha at Day 30 |
146.5 | — |
| SECONDARY CD4 Cell Count at Day 30 |
252 | — |
| SECONDARY CD4 Cell Count at Day 60 |
220 | — |
| SECONDARY CD8 Cell Count at Day 30 |
255 | — |
| SECONDARY CD8 Cell Count at Day 60 |
199 | — |
| SECONDARY NK Cell Count at Day 30 |
226 | — |
| SECONDARY NK Cell Count at Day 60 |
221 | — |
| SECONDARY B Cell Count at Day 30 |
6 | — |
| SECONDARY B Cell Count at Day 60 |
18 | — |
| SECONDARY IL-12 at Day 7 |
8.4 | — |
| SECONDARY IL-12 at Day 14 |
13.3 | — |
| SECONDARY IFN Gamma at Day 7 |
3.9 | — |
| SECONDARY IFN Gamma at Day 14 |
20.0 | — |
| SECONDARY TNF-alpha at Day 7 |
15.9 | — |
| SECONDARY TNF-alpha at Day 14 |
43.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 years.
- 8/8 or 7/8 HLA-identical matched sibling OR Allele level 8/8 (HLA-A, B, C, DR Beta1)matched unrelated donor or 4/6 or better HLA matched cord blood.
- Patients with high risk hematologic malignancies who are appropriate candidates for a myeloablative allogeneic stem cell transplantation.
- Patients with a history of CNS disease must have been treated and have no active CNS disease at the time of protocol treatment.
- ECOG performance status or equal to 30ml/min. Hepatic transaminases (ALT/AST) or equal to 50% of predicted for age and DLCO > or equal to 50% of predicted.
- Ejection fraction of > or equal to 45% by echocardiogram, radionuclide scan or cardiac MRI.
- Patients must be HIV negative.
- Patients must not be pregnant.
Exclusion Criteria
- Patients with > 5% blasts in bone marrow or peripheral circulation.
- Uncontrolled infection.
- Class III or IV angina as per NYHA criteria.
Data sourced from ClinicalTrials.gov (NCT01280955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.