Acute Myeloid Leukaemia RecurrentPhase 1AMPCALNCT03825146
The Effects of AMPC in the Treatments of Refractory or Relapsed AML
A Phase 1 study testing Autologous Multi-lineage Potential Cells (AMPC) in people with Acute Myeloid Leukaemia Recurrent, run by Lai Corporation Pty. Ltd. at 1 site in Thailand.
Trial summary
A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Acute Myeloid Leukaemia Recurrent
- What is being tested?
- Autologous Multi-lineage Potential Cells (AMPC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 4 Jan 2019to Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Panacee Hospital Rama 2
Samut Sakhon, 74000
Supachai Ekwattanakit, Ph.D., M.D., +66-86393-3452, supachai.ekw@mahidol.ac.th
About this study
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
Read the 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 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
- Conditions
- Acute Myeloid Leukaemia Recurrent
- Being tested
- Autologous Multi-lineage Potential Cells (AMPC)
- Keywords
- relapse/refractory acute myeloid leukaemia, autologous progenitor cells
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (AMPC) | Experimental | AMPC will be intravenously infused. Receives: Biological: Autologous Multi-lineage Potential Cells (AMPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
Safety profile and treatment-related adverse events (AE) upto 12-month follow up period
AE is defined as any unintended or undesirable experience that occur during the course of the clinical investigation regardless of whether they are considered to be drug-related.
Measured: 12 months
ORR of AMPC in refractory/relapsed AML at 3 and 6 months
Measured: 3 and 6 months
Overall survival (OS) rate at 12 months
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start4 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukaemia RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open label, prospective study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lai Corporation Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Supachai Ekwattanakit, Lai Corporation Pty. Ltd.
- Investigators
- Supachai Ekwattanakit, Ph.D, M.D., Principal investigator, Panacee Hospital Rama 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825146
- Sponsor's protocol ID
- SOP-PNC-REC-01/01-061
- Acronym
- AMPCAL
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03825146
- Acronym / sponsor ID
- AMPCAL / SOP-PNC-REC-01/01-061
- Conditions
- Acute Myeloid Leukaemia Recurrent
- Keywords
- relapse/refractory acute myeloid leukaemia, autologous progenitor cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lai Corporation Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open label, prospective study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (AMPC) | Experimental | Biological: Autologous Multi-lineage Potential Cells (AMPC)AMPC will be intravenously infused. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Multi-lineage Potential Cells (AMPC)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. | Biological | Treatment Arm (AMPC) |
Primary outcome
Overall response rate (ORR) of AMPC in refractory/relapsed AML at 12 months
Time frame: 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
4 secondary outcomes
Safety profile and treatment-related adverse events (AE) upto 12-month follow up period
Time frame: 12 months
ORR of AMPC in refractory/relapsed AML at 3 and 6 months
Time frame: 3 and 6 months
Overall survival (OS) rate at 12 months
Time frame: 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.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supachai Ekwattanakit, Ph.D, M.D. principal investigator
Panacee Hospital Rama 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Multi-lineage Potential Cells (AMPC) in people with Acute Myeloid Leukaemia Recurrent, run by Lai Corporation Pty. Ltd. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Supachai Ekwattanakit, Ph.D, M.D. (+66-86393-3452, supachai.ekw@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) of AMPC in refractory/relapsed AML at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.