Status:
UNKNOWN
The Effects of AMPC in the Treatments of Refractory or Relapsed AML
Lead Sponsor:
Lai Corporation Pty. Ltd.
Conditions:
Acute Myeloid Leukaemia Recurrent
Eligibility:
All Genders
20-60 years
Phase:
PHASE1
Brief Summary
A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML
Detailed Description
After inclusion and exclusion criteria has been determined and approved, written informed consent will be obtained from the candidate. All medical history relevant to the diagnosis of AML will be coll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03825146
Start Date
January 4 2019
End Date
January 1 2021
Last Update
February 24 2020
Active Locations (1)
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1
Panacee Hospital Rama 2
Samut Sakhon, Thailand, 74000