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About
A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML
Full 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 collected.
Screening period:
The screening period could extend from 0 to 7 days depending on the completion of screening laboratory results as below.
On day -5 (up to day -1), the patient will undergo a screening test for the following test items:
Bone marrow biopsy can be omitted if the prior study performed within 14 days before day-5 and the available materials (core biopsy and slides) and result can be obtained for pathological review. In this case, only bone marrow aspiration for Wright's stain, flow cytometry, and chromosome study will be performed.
Bone marrow biopsy will be repeated if the previous result has been performed more than 14 days prior to day -5 and/or FBC at day -5 reveals peripheral blast count higher than 10% of total white blood cells.
For chromosome study (cytogenetics), the previous result before the recent line of chemotherapy prior to enrollment can be used for the screening data.
On day 0, peripheral blood will then be collected, ranging from 250mL to 400mL depending on candidate fitness. The blood is collected into a sterile blood bag and sealed. Subsequent processes will be conducted in the blood bag within a closed-system to minimize contamination risks. FBC will be collected in order to determine the disease status. After that, the investigator will consider to prescribe blood transfusion for the candidate.
On day 0 to day 3, the collected blood will be sent to the laboratory for stem cell culture, and a sample of the collected blood will be sent to a third-party laboratory for contamination testing of the following parameters:
On day 4, the biotest results will be released and the safety profiles of the AMPC product must be completed and passed before the cultured stem cells may be released for treatment
On day 5, candidates will receive an infusion of the cultured stem cells. Prior to the infusion, FBC and blood chemistry (BUN, Cr, electrolyte, LFT) will be collected and the treating doctor will first conduct an allergy skin test to determine suitability for reinfusion. The cultured stem cells are then reinfused intravenously into the candidate in a process that could take up to 2 hours
The candidate participation will take place on day 0 to day 1 or 2 (if blood transfusion is required) and day 5 (period adjusted for blood transfusion if required) for peripheral blood collection and stem cell reinfusion respectively; with 12 month follow up after treatment;
Enrollment
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Inclusion criteria
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;
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
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Supachai Ekwattanakit, Ph.D, M.D.
Data sourced from clinicaltrials.gov
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