The Effects of AMPC in the Treatments of Refractory or Relapsed AML

NCT03825146 | Unknown Phase 1

• 1 other identifier: SOP-PNC-REC-01/01-061
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML

Conditions

Acute Myeloid Leukaemia Recurrent

Keywords

relapse/refractory acute myeloid leukaemia; autologous progenitor cells

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) of AMPC in refractory/relapsed AML at 12 months

  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

  12 months

Secondary Outcomes (4)

• Safety profile and treatment-related adverse events (AE) upto 12-month follow up period

  12 months

• ORR of AMPC in refractory/relapsed AML at 3 and 6 months

  3 and 6 months

• Overall survival (OS) rate at 12 months

  12 months

• Time-to-next treatment (TTNT), defined as the time from the start of AMPC therapy to the start date of a subsequent line of therapy.

  12 months

Study Arms (1)

Treatment Arm (AMPC)

EXPERIMENTAL

AMPC will be intravenously infused.

Biological: Autologous Multi-lineage Potential Cells (AMPC)

Interventions

Autologous Multi-lineage Potential Cells (AMPC) BIOLOGICAL

Multi-lineage potential cells which were induced to de-differentiate from somatic leukocytes from peripheral blood. Cells are autologous with respect to the patient, and are prepared in a suspension and administered via intravenous infusion. An estimated average of 1 x 10\^8 (0.5 to 5.0 x 10\^8) cells/per suspension(275 to 450mL) will be infused into the patient via intravenous infusion on day 5. Cell counts depend on yield of initial leukocyte harvest on day 0.

Treatment Arm (AMPC)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lai Corporation Pty. Ltd.: lead

Study Sites (1)

Panacee Hospital Rama 2

Samut Sakhon, 74000, Thailand

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Supachai Ekwattanakit, Ph.D, M.D.

  Panacee Hospital Rama 2

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supachai Ekwattanakit, Ph.D, M.D.

CONTACT

+66-86393-3452; supachai.ekw@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Single-arm, open label, prospective study

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: January 4, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

TH (1)