Phase
Condition
Lymphoproliferative Disorders
Bone Neoplasm
Canker Sores
Treatment
MIT-001
normal saline
Clinical Study ID
Ages 19-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women aged 19 to 70 years old
Patients with lymphoma or multiple myeloma planned for receiving one of thefollowing conditioning chemotherapy followed by autologous hematopoietic stem celltransplantation
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 daysof conditioning chemotherapy
BMT Regimen: Busulfan (iv) 2.4 mg/kg (Day 1, Day 2, Day 3) + Melphalan (iv) 40mg/m2 (Day 4, Day 5) + Thiotepa (iv) 200 mg/ m2 (Day 6, Day 7), and autologousHSCT 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 HSCTafter 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 4days of conditioning chemotherapy (In part 2, BUCYE, BMT and MELPHALAN regimensare allowed.)
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 properthrough the following laboratory test results last measured within 8 days prior tothe investigational product(IP) administration Laboratory endpoint Required limitfor inclusion Absolute neutrophil count (ANC) ≥ 1,000/mm^3 Hemoglobin (Hb) ≥ 9.0g/dL Platelet count ≥ 100,000/mm^3 Total bilirubin (TB) ≤ 2 mg/Dl AST and ALT ≤ 3.0x ULN(if liver metastasis, ≤ 5 x ULN) Prothrombin time (PT) INR ≤ 1.5 (if takingwarfarin, < 3) Serum creatinine or creatinine clearance (CrCl) < 2 mg/dL or≥ 60mL/min
Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0or 1
Patients who voluntarily decided to participate in this study after being informedof the study information, and provided written consent to faithfully comply with thestudy requirements
Exclusion
Exclusion Criteria:
- 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 infectiousdiseases at screening that require administration of antibiotics, antibacterialagents, antifungal agents, antivirals, etc. (e.g., Human Immunodeficiency Viruspositive, active hepatitis B or active hepatitis C, etc.) However, in case ofadministration 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 beforescreening, which includes, but not limited to Severe heart disease (heartfailure (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 arrhythmiaand peripheral vascular diseases confirmed by the investigator Hypertrophicobstructive cardiomyopathy, clinically significant heart valve disease oraortic disease
Patients who are considered inappropriate to participate in the study becausethey have uncontrolled disease and have a comorbid disease that requirestreatment by the investigator's judgement (e.g., blood coagulation disorder,bleeding disorder or bleeding diatheses, pulmonary function decline, decline inrenal 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
- If the following therapy has been administered or received, or when the need foradministration is expected
The following therapies within 12 weeks before the baseline that may have asignificant effect on the results of the study Palifermin Oral low-level lasertherapy Oral cryotherapy Glutamine (parenteral, IV supplement of protein aminoacids containing glutamic acid, not glutamine supplements, are permitted)
Vaccination of yellow fever vaccine or other live attenuated vaccine within 4weeks 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 ispermitted and subjects who have been irradiated with head and neck within thelast 2 years are excluded.) (*Radio(chemo)therapy, chemotherapy, targetedtherapy (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 daysbefore the baseline to the end of treatment (EOT) period Strong CYP3A4inhibitors: 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 apregnancy plan up to 30 days after the end of the IP administration or who do notintend to use appropriate contraception: ① Hormonal contraceptives, ② Implantationof an intrauterine device or intrauterine system, ③ Double blocking method withspermicide (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 ofIP administration and received other study drug (or medical devices)
Patient who are judged to be difficult to participate in the study according to theopinions of investigators
Study Design
Study Description
Connect with a study center
Seoul ST. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Yeouido ST. Mary's Hospital
Seoul,
Korea, Republic ofSite Not Available

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