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Lymphosarcoma

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.

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.

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.

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.

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.

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.

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.

Corresponding dose of MIT-001 IV injection during 0.5\~1hr

MIT-001

normal saline

Seok-Goo Cho, MD, PhD

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).

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.

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.

Part I: open label

Part II: double blind, randomized, and Placebo controlled

Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

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

The number and incidence rate of AEs will be investigated.

* achievement of ANC \> 0.5x10\^9/L for three consecutive days
* achievement of peripheral platelet \> 20 X 10\^9/L for three consecutive days

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)

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)

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)

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)

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)

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

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

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)

The proportion of patients who used opioid analgesics up to 14 days after the end of therapy.

It will be calculated as morphine equivalents dose

Spots Global Cancer Trial Database for necrosis inhibitor