Acute Myeloid Leukaemia Recurrent Clinical Trial
Official title:
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)
A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML
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:
- BUN, creatinine, electrolyte, liver function test (LFT)
- Full blood count (FBC), including blood smear
- Hepatitis B/C
- Human T lymphocytic virus type I and II (HTLV-I/II)
- HIV1/2
- Syphilis serology
- Mycoplasma serology For Hepatitis B/C,HTLV-I/II, HIV1/2, Syphilis serology, and
Mycoplasma serology, these tests obtained up to 3 months prior to day -5 can be allowed
for using as screening result.
- Chest X-ray
- Bone marrow study including aspiration with wright's stain, biopsy, flow cytometry, and
chromosome study (Any molecular testing for AML is optional.).
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:
- Bacterial endotoxin
- Total viable aerobic count
- Total viable count
- Microbial growth
- Mycoplasma real-time PCR test
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;
- 3 days post-treatment follow-up: full blood count test and blood smear, BUN, Cr,
electrolyte, LFT
- 10 days post-treatment follow-up: full blood count test and blood smear, BUN, Cr,
electrolyte, LFT
- 1 month (+/-7 days) post-treatment follow-up: full blood count test and blood smear,
BUN, Cr, electrolyte, LFT, bone marrow study
- 3 month (+/-7 days) post-treatment follow-up: full blood count test and blood smear,
BUN, Cr, electrolyte, LFT, bone marrow study
- 6 month (+/-7 days) post-treatment follow-up: full blood count test with bone marrow
study
- 12 month (+/-7 days) post-treatment follow-up: full blood count test with bone marrow
study
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03957915 -
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
|
Early Phase 1 |