Clinical trial · Interventional
The Effects of AMPC in the Treatments of Refractory or Relapsed AML
A Phase I Single-arm, Open-label Prospective Study to Evaluate the Efficacy and Safety of Peripheral Blood Derived Autologous Multi-lineage Potential Cells (AMPC) in Relapsed/Refractory Acute Myeloid Leukemia (AMPCAL Study)
NCT03825146CI-TRIAL-00043598AMPCALunknownPhase 1ClinicalTrials.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)
A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML
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 Leukaemia Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Multi-lineage Potential Cells (AMPC) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm (AMPC)
- description
- AMPC will be intravenously infused.
- interventionNames
- Biological: Autologous Multi-lineage Potential Cells (AMPC)
Primary outcomes (1)
- measure
- Overall response rate (ORR) of AMPC in refractory/relapsed AML at 12 months
- timeFrame
- 12 months
- description
- Overall response rate (ORR) is defined as whether the patient achieves complete remission (CR) or complete remission with incomplete blood count recovery (CRi) CR Requirements: * Bone marrow aspiration shows less than 5% of abnormal blasts as determined by evidence from flow cytometry or immunohistochemistry * Bone marrow biopsy shows no clusters of blast cell * Normal values for absolute neutrophil count in peripheral blood exceeds 1,000/microL * Platelet count in peripheral blood exceeds 100,000/microL * Absence of extramedullary AML CRi Requirements: * All parameters of CR except platelet recovery or neutrophil recovery * Incomplete recovery-platelet count is less than 100,000/microL or neutrophil count less than 1,000/microL in peripheral blood
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Must be unequivocally diagnosed with AML according to WHO classification with accompanying bone marrow biopsy and blood panel results * Must have refractory AML, defined as disease unresponsive to initial treatment; or relapsed AML that re-occured after treatment with conventional high dose chemotherapy * Candidates who have no available match-sibling donor for bone marrow transplantation (BMT) or are not suitable for BMT due to any reason. * Must have had prior treatment with chemotherapy at least 30 days prior to day 0 of this study and have recovered from treatment-related toxicity of chemotherapeutic agents with the exception of persistent diseases * Age 20 to 60 years old Exclusion Criteria: * Candidates who received any investigational therapies 4 weeks prior to treatment with this protocol * Candidates who received radiotherapy within 4 weeks prior to the treatment of this protocol * Candidates who have not recovered from any AE caused by radiotherapy or any agents received 4 weeks earlier * Candidates who have had a prior allogeneic stem cell transplant * Known case of extramedullary myeloid tumor (myeloid sarcoma) * Pregnant or breastfeeding women * Hydroxyurea has been prescribed within 10 days prior to day-5 * Candidates have any abnormal screening laboratory results as below; * Hemoglobin \< 9 g/dL * Total white blood cells count \> 30,000/microL (without ongoing G-CSF therapy) * Platelet count \< 75,000/microL * Creatinine clearance \< 30 mL/min/1.73 m2 (by Cockcroft and Gault formula) * ALT \> 5x upper normal limit * Bone marrow study at screening period show blast \> 40% of total nucleated cells or severe hypocellularity (defined as \< 25% of normal cellularity for corresponding age) with presence of cluster of blasts * Candidates have active heart disease including recent or chronic heart failure, unstable angina, recent acute myocardial infarction, or significant arrhythmia within 6 months of recruitment. * Candidates have concurrent malignancies unless the candidates has been free of the disease for at least 5 years. * Candidates positive for HIV1/2, hepatitis B/C, HTLVI/II, and Syphilis
References
Publications (0)
Data not yet available
No reference posted for this study.