Oral MucositisPhase 2CapellaNCT05493800
Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT
A Phase 2 study testing MIT-001 and normal saline in people with Oral Mucositis and Lymphoma, run by MitoImmune Therapeutics at 2 sites in South Korea.
Trial summary
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Oral Mucositis, Lymphoma, Multiple Myeloma
- What is being tested?
- MIT-001 and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Feb 2022to 30 Dec 2024
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 19 to 70 years old
- Patients with lymphoma or multiple myeloma planned for receiving one of the following conditioning chemotherapy followed by autologous hematopoietic stem cell transplantation
- BuCyE Regimen: Busulfan (iv) 3.2 mg/kg (Day 1, Day 2, Day 3) + Etoposide (iv) 400 mg/m² (Day 3, Day 4) + Cyclophosphamide (iv) 50 mg/kg/Mesna (iv) 50 mg/kg (Day 5, Day 6), and autologous HSCT after 1 day rest after completion of 6 days of conditioning chemotherapy
- BMT Regimen: Busulfan (iv) 2.4 mg/kg (Day 1, Day 2, Day 3) + Melphalan (iv) 40 mg/m2 (Day 4, Day 5) + Thiotepa (iv) 200 mg/ m2 (Day 6, Day 7), and autologous HSCT after 1 day rest after completion of 7 days of conditioning chemotherapy
- Melphalan Regimen: Melphalan (iv) 100 mg/m2 (Day 1, Day 2), and autologous HSCT after 1 day rest after completion of 2 days of conditioning chemotherapy
- BuMel Regimen: Busulfan (iv) 3.2 mg/kg (Day 1, Day 2, Day 3) + Melphalan (iv) 140 mg/m2 (Day 4), and autologous HSCT after 1 day rest after completion of 4 days of conditioning chemotherapy (In part 2, BUCYE, BMT and MELPHALAN regimens are allowed.)
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- Patients who have not received a hematopoietic stem cell transplant before
- Patients with Body Mass Index (BMI) 35 or less
- Patients who have prepared at least 2 x 10^6 CD34+ cell/kg
- Patients whose hematologic, kidney and liver functions were confirmed to be proper through the following laboratory test results last measured within 8 days prior to the investigational product(IP) administration Laboratory endpoint Required limit for inclusion Absolute neutrophil count (ANC) ≥ 1,000/mm^3 Hemoglobin (Hb) ≥ 9.0 g/dL Platelet count ≥ 100,000/mm^3 Total bilirubin (TB) ≤ 2 mg/Dl AST and ALT ≤ 3.0 x ULN(if liver metastasis, ≤ 5 x ULN) Prothrombin time (PT) INR ≤ 1.5 (if taking warfarin, < 3) Serum creatinine or creatinine clearance (CrCl) < 2 mg/dL or≥ 60 mL/min
- Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1
- Patients who voluntarily decided to participate in this study after being informed of the study information, and provided written consent to faithfully comply with the study requirements
Who cannot join
- Patients who has the following medical history or concomitant diseases at screening
- Patients with oral mucositis or oral ulcer at screening
- Patients who have severe infections or other uncontrolled active infectious diseases at screening that require administration of antibiotics, antibacterial agents, antifungal agents, antivirals, etc. (e.g., Human Immunodeficiency Virus positive, active hepatitis B or active hepatitis C, etc.) However, in case of administration of antiviral drugs in patients with hepatitis B or C infection, whose disease is controlled, the subjects can be enrolled.
- Patients who have major cardiovascular disease within 6 months before screening, which includes, but not limited to Severe heart disease (heart failure (NYHA class 3 and 4), acute coronary artery disease (unstable angina, acute myocardial infarction), clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other clinically significant arrhythmia and peripheral vascular diseases confirmed by the investigator Hypertrophic obstructive cardiomyopathy, clinically significant heart valve disease or aortic disease
- Patients who are considered inappropriate to participate in the study because they have uncontrolled disease and have a comorbid disease that requires treatment by the investigator's judgement (e.g., blood coagulation disorder, bleeding disorder or bleeding diatheses, pulmonary function decline, decline in renal function, hypotension, hypertension, hepatitis, liver cirrhosis, etc)
- Patients who have major mental illness (e.g., depression, bipolar disorder, etc.) or a history of drug/alcohol abuse
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- If the following therapy has been administered or received, or when the need for administration is expected
- The following therapies within 12 weeks before the baseline that may have a significant effect on the results of the study Palifermin Oral low-level laser therapy Oral cryotherapy Glutamine (parenteral, IV supplement of protein amino acids containing glutamic acid, not glutamine supplements, are permitted)
- Vaccination of yellow fever vaccine or other live attenuated vaccine within 4 weeks before the baseline
- Anti-cancer or radiation therapy* within 3 weeks before the baseline (However, the use of Anti-cancer drugs for hematopoietic stem cell collection is permitted and subjects who have been irradiated with head and neck within the last 2 years are excluded.) (*Radio(chemo)therapy, chemotherapy, targeted therapy (small molecule drugs, monoclonal antibodies), cancer immunotherapy (biological drugs), or hormone therapy, etc.)
- The following drugs that may affect the metabolism of IP from within 7 days before the baseline to the end of treatment (EOT) period Strong CYP3A4 inhibitors: boceprevir, citrus x paradisi, clarithromycin, cobicistat, conivaptan, delavirdine, diltiazem, idelalisib, indinavir, itraconazole, ketoconazole, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, lopinavir/ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, voriconazole Strong CYP3A4 inducers: avasimibe, carbamazepine, enzalutamide, fosphenytoin, hypericum perforatum, lumacaftor, methylphenobarbital, mitotane, phenobarbital, phenobarbital quinine, primidone, rifabutin, rifampicin, rifapentine OATP inhibitors: cyclosporin A, cyclosporine, estradiol-17β-glucuronide, estrone-3-sulfate, rifampicin, rifamycin SV, lopinavir/ritonavir
- Pregnant and lactating women or women or childbearing potential and men who have a pregnancy plan up to 30 days after the end of the IP administration or who do not intend to use appropriate contraception: ① Hormonal contraceptives, ② Implantation of an intrauterine device or intrauterine system, ③ Double blocking method with spermicide (both male condom and closed cap (contraceptive diaphragm or neck cap) are used), ④ Infertility procedures (e.g., vasectomy, bilateral tubal ligation, etc.)
- Patients who participated in other clinical trials within 30 days from the start of IP administration and received other study drug (or medical devices)
- Patient who are judged to be difficult to participate in the study according to the opinions of investigators
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul ST. Mary's Hospital
Seoul, 06591
Yeouido ST. Mary's Hospital
Seoul
About this study
Official title: A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).
Read the detailed description
In Part 1, it was to determine Recommended Part 2 Dose(RP2D) the prevention effect of MIT-001 in combination with conditioning regimen in autologous hematopoietic stem cell transplantation(auto-HSCT) and to evaluate the pharmacokinetic characteristics of MIT-001.
In Part 2, it's to determine the optimal dose of MIT-001 in combination with conditioning regimen in auto-HSCT.
This clinical trial consists of a 28-days of screening period, 4 to 9 days of conditioning chemotherapy with MIT-001 treatment, auto-HSCT and a 14-days of follow-up and recovery period.
MIT-001 group consists of 5 mg (group 1), 10 mg (group 2), and 20mg (group 3), and the subject will be assigned to from 5 mg of MIT-001 sequentially.
After completion of MIT-001 administration from all 3 MIT-001 groups, Steering Committee (SC) was convened and reviewed the safety and efficacy to determine one of the followings.
- Determine whether the next dose (Group 4: 30 mg) in Part 1: It was not proceeded.
- Determine the RP2D to enter Part 2 phase: 5mg as low dose, 20mg as high dose for Part 2 The investigators will continuously monitor the safety of MIT-001, and can request the steering committee call at any time, and can be carefully reviewed the data such as safety and efficacy.
In Part 2, the subjects are randomly assigned to either one of MIT-001 treatment groups (high-dose, low-dose among RP2D) and placebo at a ratio of 1: 1: 1. If two or more conditioning regimen are determined, conditioning regimen can be considered the stratification factor. Subject will be randomly assigned to either group in blinded method.
- Conditions
- Oral Mucositis, Lymphoma, Multiple Myeloma, Hematologic Cancer
- Being tested
- MIT-001, normal saline
- Keywords
- oral mucositis, MIT-001, auto HSCT, HSCT, hematopoietic stem cell transplantation, ferroptosis inhibitor, necrosis inhibitor
- Medical subject headings
- Stomatitis, Lymphoma, Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIT-001Drug
Corresponding dose of MIT-001 IV injection during 0.5~1hr
normal salineDrug
Also called placebo
normal saline IV injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1, MIT-001 5 mg group | Experimental | Part 1, MIT-001 5 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
5 subject were enrolled sequentially. Receives: Drug: MIT-001 |
| Part 1, MIT-001 10 mg group | Experimental | Part 1, MIT-001 10 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
6 subjects were enrolled sequentially. Receives: Drug: MIT-001 |
| Part 1, MIT-001 20 mg group | Experimental | Part 1, MIT-001 20 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
5 subjects were enrolled sequentially. Receives: Drug: MIT-001 |
| Part 1, MIT-001 30 mg group | Experimental | Part 1, MIT-001 30 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
It was optional but did not ptoceed according to Steering committee's decision because low level of MIT-001 is enough to show the efficacy and safety of MIT-001. Receives: Drug: MIT-001 |
| Part 2, 5mg of MIT-001 low dose group | Experimental | Part 2, MIT-001 low dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
15 subject will be enrolled parallelly. Receives: Drug: MIT-001 |
| Part 2, 20mg of MIT-001 high dose group | Experimental | Part 2, MIT-001 high dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
15 subject will be enrolled parallelly. Receives: Drug: MIT-001 |
| Part 2, placebo(normal saline) group | Placebo comparator | Part 2, placebo(normal saline), once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr.
15 subject will be enrolled parallelly. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Severe Oral Mucositis(SOM).
OM is evaluated using the World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.
SOM is defined as a WHO score of greater than or equal to 3.
OM grading scale
Grade 0 = Normal
Grade 1 = Erythema and Soreness
Grade 2 = Ulceration but can eat solid foods
Grade 3 = Ulceration,diet limited to liquid (due to mucositis)
Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
Secondary outcomes (9)
The incidence of oral mucositis by WHO OM grading scale
① Grade 1 or higher, ② Grade 2 or higher, ③ Grade 4 or higher
OM grading scale
Grade 0 = Normal
Grade 1 = Erythema and Soreness
Grade 2 = Ulceration but can eat solid foods
Grade 3 = Ulceration,diet limited to liquid (due to mucositis)
Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The incidence of oral mucositis based on the maximum severity by WHO OM grading scale
① Grade 1 ② Grade 2 ③ Grade 3 ④ Grade 4
OM grading scale
Grade 0 = Normal
Grade 1 = Erythema and Soreness
Grade 2 = Ulceration but can eat solid foods
Grade 3 = Ulceration,diet limited to liquid (due to mucositis)
Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The average grade of oral mucositis by WHO OM grading scale
The average grade of each point
OM grading scale
Grade 0 = Normal
Grade 1 = Erythema and Soreness
Grade 2 = Ulceration but can eat solid foods
Grade 3 = Ulceration,diet limited to liquid (due to mucositis)
Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
Measured: Each 1, 5, 7, 14, 21 and 28 day after the end of therapy
The duration of oral mucositis by WHO OM grading scale
① Grade 2 or higher, ② Grade 3 or higher, ③ Grade 4 or higher
OM grading scale
Grade 0 = Normal
Grade 1 = Erythema and Soreness
Grade 2 = Ulceration but can eat solid foods
Grade 3 = Ulceration,diet limited to liquid (due to mucositis)
Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The incidence of oral mucositis by NCI-CTCAE v5.0 criteria
① Grade 1 or higher, ② Grade 2 or higher, ③ Grade 3 or higher, ④ Grade 4 or higher
Grade 0 = Normal
Grade 1 = Asymptomatic or mild symptoms; intervention not indicated
Grade 2 = Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
Grade 3 = Severe pain; interfering with oral intake
Grade 4 = Life-threatening consequences; urgent intervention indicated
Grade 5 = Death
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The average grade of oral mucositis by NCI-CTCAE v5.0 criteria
The average grade of each point
Grade 0 = Normal
Grade 1 = Asymptomatic or mild symptoms; intervention not indicated
Grade 2 = Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
Grade 3 = Severe pain; interfering with oral intake
Grade 4 = Life-threatening consequences; urgent intervention indicated
Grade 5 = Death
Measured: Each 1, 5, 7, 14, 21 and 28 day after the end of therapy
The mean area under curve(AUC) of score for each question in oral mucositis daily questionnaire(OMDQ)
Q1: General health condition scale: 0(worst possible) to 10(perfect health)
Q2: Mouth and throat pain: 0(no soreness) to 4(extreme soreness)
Q3: Salvia swallowing, drinking water, eat rice, speaking ans sleeping: 0(no soreness) to 4(extreme soreness)
Q4: General mouth and throat pain: 0(no soreness) to 10(worst possible)
Measured: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The proportion of using opioid analgesics
The proportion of patients who used opioid analgesics up to 14 days after the end of therapy.
Measured: From the baseline to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
Total cumulative dose of opioid analgesics
It will be calculated as morphine equivalents dose
Measured: From the baseline to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 was completed with 16 patients and open label design to to evaluate the pharmacokinetic characteristics, efficacy, and safety of MIT-001 on prevention effect of MIT-001 in combination with conditioning regimen in auto-HSCT. 5mg as low dose and 20mg as high dose of MIT-001 were determined as RP2D through steering comittee and optional group of 30mg was not needed at Part 1 because low level of MIT-001 was enough to show efficacy and safety of MIT-001. In Part 2, it's to determine the optimal dose (recommended part 2 dose (RP2D)) of MIT-001 in combination with conditioning regimen in auto-HSCT.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MitoImmune Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seok-Goo Cho, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493800
- Sponsor's protocol ID
- MIT001-OM-02
- Acronym
- Capella
- Status last verified
- May 2024
- First submitted
- 3 Aug 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT
- ClinicalTrials.gov ID
- NCT05493800
- Acronym / sponsor ID
- Capella / MIT001-OM-02
- Conditions
- Oral Mucositis, Lymphoma, Multiple Myeloma, Hematologic Cancer
- Keywords
- oral mucositis, MIT-001, auto HSCT, HSCT, hematopoietic stem cell transplantation, ferroptosis inhibitor, necrosis inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MitoImmune TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Aug 2022 (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.
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).
Detailed description
In Part 1, it was to determine Recommended Part 2 Dose(RP2D) the prevention effect of MIT-001 in combination with conditioning regimen in autologous hematopoietic stem cell transplantation(auto-HSCT) and to evaluate the pharmacokinetic characteristics of MIT-001.
In Part 2, it's to determine the optimal dose of MIT-001 in combination with conditioning regimen in auto-HSCT.
This clinical trial consists of a 28-days of screening period, 4 to 9 days of conditioning chemotherapy with MIT-001 treatment, auto-HSCT and a 14-days of follow-up and recovery period.
MIT-001 group consists of 5 mg (group 1), 10 mg (group 2), and 20mg (group 3), and the subject will be assigned to from 5 mg of MIT-001 sequentially.
After completion of MIT-001 administration from all 3 MIT-001 groups, Steering Committee (SC) was convened and reviewed the safety and efficacy to determine one of the followings.
- Determine whether the next dose (Group 4: 30 mg) in Part 1: It was not proceeded.
- Determine the RP2D to enter Part 2 phase: 5mg as low dose, 20mg as high dose for Part 2 The investigators will continuously monitor the safety of MIT-001, and can request the steering committee call at any time, and can be carefully reviewed the data such as safety and efficacy.
In Part 2, the subjects are randomly assigned to either one of MIT-001 treatment groups (high-dose, low-dose among RP2D) and placebo at a ratio of 1: 1: 1. If two or more conditioning regimen are determined, conditioning regimen can be considered the stratification factor. Subject will be randomly assigned to either group in blinded method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Part 1 was completed with 16 patients and open label design to to evaluate the pharmacokinetic characteristics, efficacy, and safety of MIT-001 on prevention effect of MIT-001 in combination with conditioning regimen in auto-HSCT. 5mg as low dose and 20mg as high dose of MIT-001 were determined as RP2D through steering comittee and optional group of 30mg was not needed at Part 1 because low level of MIT-001 was enough to show efficacy and safety of MIT-001. In Part 2, it's to determine the optimal dose (recommended part 2 dose (RP2D)) of MIT-001 in combination with conditioning regimen in auto-HSCT.
| Arm | Type | Receives |
|---|---|---|
| Part 1, MIT-001 5 mg group | Experimental | Drug: MIT-001Part 1, MIT-001 5 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 5 subject were enrolled sequentially. |
| Part 1, MIT-001 10 mg group | Experimental | Drug: MIT-001Part 1, MIT-001 10 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 6 subjects were enrolled sequentially. |
| Part 1, MIT-001 20 mg group | Experimental | Drug: MIT-001Part 1, MIT-001 20 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 5 subjects were enrolled sequentially. |
| Part 1, MIT-001 30 mg group | Experimental | Drug: MIT-001Part 1, MIT-001 30 mg, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. It was optional but did not ptoceed according to Steering committee's decision because low level of MIT-001 is enough to show the efficacy and safety of MIT-001. |
| Part 2, 5mg of MIT-001 low dose group | Experimental | Drug: MIT-001Part 2, MIT-001 low dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 15 subject will be enrolled parallelly. |
| Part 2, 20mg of MIT-001 high dose group | Experimental | Drug: MIT-001Part 2, MIT-001 high dose, once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 15 subject will be enrolled parallelly. |
| Part 2, placebo(normal saline) group | Placebo comparator | Drug: normal salinePart 2, placebo(normal saline), once a day IV administration for 30 minutes before conditioning regimen administration 0.5~1 hr. 15 subject will be enrolled parallelly. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women aged 19 to 70 years old
- Patients with lymphoma or multiple myeloma planned for receiving one of the following conditioning chemotherapy followed by autologous hematopoietic stem cell transplantation
- Patients who have not received a hematopoietic stem cell transplant before
- Patients with Body Mass Index (BMI) 35 or less
- Patients who have prepared at least 2 x 10^6 CD34+ cell/kg
Key exclusion criteria (14 listed)
- Patients who has the following medical history or concomitant diseases at screening
- If the following therapy has been administered or received, or when the need for administration is expected
- Pregnant and lactating women or women or childbearing potential and men who have a pregnancy plan up to 30 days after the end of the IP administration or who do not intend to use appropriate contraception: ① Hormonal contraceptives, ② Implantation of an intrauterine device or intrauterine system, ③ Double blocking method with spermicide (both male condom and closed cap (contraceptive diaphragm or neck cap) are used), ④ Infertility procedures (e.g., vasectomy, bilateral tubal ligation, etc.)
- Patients who participated in other clinical trials within 30 days from the start of IP administration and received other study drug (or medical devices)
- Patient who are judged to be difficult to participate in the study according to the opinions of investigators
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 |
|---|---|---|
| MIT-001Corresponding dose of MIT-001 IV injection during 0.5~1hr | Drug | Part 1, MIT-001 10 mg group, Part 1, MIT-001 20 mg group, Part 1, MIT-001 30 mg group, Part 1, MIT-001 5 mg group, Part 2, 20mg of MIT-001 high dose group, Part 2, 5mg of MIT-001 low dose group |
| normal salineAlso: placebonormal saline IV injection | Drug | Part 2, placebo(normal saline) group |
Primary outcome
The incidence of Severe Oral Mucositis(SOM).
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
OM is evaluated using the World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. OM grading scale Grade 0 = Normal Grade 1 = Erythema and Soreness Grade 2 = Ulceration but can eat solid foods Grade 3 = Ulceration,diet limited to liquid (due to mucositis) Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis)
9 secondary outcomes
The incidence of oral mucositis by WHO OM grading scale
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The incidence of oral mucositis based on the maximum severity by WHO OM grading scale
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The average grade of oral mucositis by WHO OM grading scale
Time frame: Each 1, 5, 7, 14, 21 and 28 day after the end of therapy
The duration of oral mucositis by WHO OM grading scale
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The incidence of oral mucositis by NCI-CTCAE v5.0 criteria
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The average grade of oral mucositis by NCI-CTCAE v5.0 criteria
Time frame: Each 1, 5, 7, 14, 21 and 28 day after the end of therapy
The mean area under curve(AUC) of score for each question in oral mucositis daily questionnaire(OMDQ)
Time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
The proportion of using opioid analgesics
Time frame: From the baseline to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
Total cumulative dose of opioid analgesics
Time frame: From the baseline to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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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.
Seok-Goo Cho, MD, PhD principal investigator
Seoul St. Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIT-001 and normal saline in people with Oral Mucositis and Lymphoma, run by MitoImmune Therapeutics at 2 sites in South Korea.
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 12 inclusion and 14 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Severe Oral Mucositis(SOM). (time frame: up to 14 days after the end of therapy( or discharge if hospitalization extension is necessary)). 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 29 May 2024.