A Phase IIa, Multi-center, Dose-finding Clinical Trial to Evaluate the Safety, the Efficacy for Prevention of Oral Mucositis and the Pharmacokinetics of MIT-001 in Patients with Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplantatio

Not Applicable

Active, not recruiting

Conditions: Diseases of the digestive system

Registration Number: KCT0006696

Lead Sponsor: MitoImmune Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)Men and women aged 19 to 79 years old
2)Patients with lymphoma or multiple myeloma planned for receiving one of the following conditioning chemotherapies 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#3 (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
Regarding the above pretreatment therapy, the rest period may be extended at the discretion of the investigator depending on the patient's condition and institutional practice.
3)Patients who have not received a hematopoietic stem cell transplant before
4)Patients with Body Mass Index (BMI) below 35
5)Patients who have prepared at least 2 x 106 CD34+ cell/kg
6)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 IP administration
Laboratory endpointRequired limit for inclusion
Absolute neutrophil count (ANC)= 1,000/mm3
Hemoglobin (Hb)= 9.0 g/dL
Platelet count*= 100,000/mm3
Total bilirubin (TB)= 2 mg/Dl
Aspartate aminotransferase (AST) and alanine aminotransferase (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

** Cockcroft-Gault equation
7)Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or below
8)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

Exclusion Criteria

Subjects who meet any of the following conditions cannot participate in this study.
1)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
2)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
?Vaccination of yellow fever vaccine or other live venom vaccine within 4 weeks before the baseline
?Anti-cancer or radiation therapy within 3 weeks before the baseline$
$: 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, phenytoin, primidone, rifabutin, rifampicin, rifapentine
-OATP inhibitors: cyclosporin A, cyclosporine, estradiol-17ß-glucuronide, estrone-3-sulfate, rifampicin, rifamycin SV, lopinavir/ritonavir
3)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&
&: ? Hormonal contraceptives, ? Im

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of oral mucositis of severity 3 or higher by WHO criteria

Secondary Outcome Measures

Name	Time	Method
The incidence of oral mucositis based on the maximum severity by WHO criteria;The incidence of oral mucositis at each grade by WHO criteria ? Grade 1 or higher, ? Grade 2 or higher, ? Grade 4 or higher