Clinical trial · Interventional
POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
A Phase I Study Using Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
- 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)
In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different dose levels, used together with other anti-cancer drugs-cytarabine and etoposide. We want to find out what effects, good and /or bad, this combination of drugs has on leukemia. Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric patients with relapsed or refractory ALL, AML and MDS is considered experimental.
Conditions
Conditions (6)
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 Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed/Refractory ALL | — | UNRESOLVED | — |
| Relapsed/Refractory AML | — | UNRESOLVED | — |
| Secondary AML/MDS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor Dose Escalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Plerixafor, Dose Escalation
- description
- Dose escalation of plerixafor administered intravenously in combination with IV cytarabine and IV etoposide in pediatric patients wtih relapsed/refractory AML/ALL.
- interventionNames
- Drug: Plerixafor Dose Escalation
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Plerixafor given in combination with chemotherapy
- timeFrame
- 6 months post final enrollment
- description
- To determine the safety and tolerability of plerixafor in combination with reinduction chemotherapy in pediatric and young adult patients with relapsed/refractory acute leukemia (AML/MDS and ALL)
Secondary outcomes (7)
- measure
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 29 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 3 years of age and \<30 years old at study entry * diagnosis of relapsed/refractory AML, ALL, secondary AML/MDS, or acute leukemia of ambiguous lineage and meet the following criteria: * AML/MDS or leukemia with ambiguous lineage must have \>5% blast in bone marrow * ALL must have an M3 marrow * ALL and AML must not have CNS disease * patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study * Karnofsky score \>50% for patients \>16 years of age and Lansky \>50% for patients \<= 16 years of age * adequate renal and hepatic function as defined in protocol * adequate cardiac function as defined in protocol Exclusion Criteria: * ALL and AML patients with CNS disease * Absolute blast count greater than 50,000/mcl * Systemic fungal, bacterial, viral or other infection without improvement despite appropriate antibiotics or other treatment * Significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance * Patients who have second cancer, not including secondary AML * Patients who are pregnant
References
Publications (0)
Data not yet available