Status Approved
First Submitted Date
2020/12/02
Registered Date
2020/12/28
Last Updated Date
2020/12/02
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005708 |
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Unique Protocol ID | XC20CIDF0042K |
Public/Brief Title | A Phase I/II clinical trial to evaluate the safety and efficacy of combined maintenance of rituximab and cytokine-induced killer cells in elderly high-risk lymphoma patients responding to the first chemotherapy |
Scientific Title | A multicenter, open, rnadomized, phase I/II clinical trial toevaluate the safety and efficacy of combined maintenance of rituximab and cytokine-induced killer cells in elderly high-risk DLBCL(Diffuse Large B-cell Lymphoma) patients responding to the first R-CHOP treatment |
Acronym | RITU_CYTO |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | XC20CIDF0042K |
Approval Date | 2020-11-24 |
Institutional Review Board Name | Catholic Central Medical Center Central Clinical Research Review Committee |
Institutional Review Board Address | 222, Banpo-daero, Seocho-gu, Seoul |
Institutional Review Board Telephone | 02-2258-8203 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seok-Goo Cho |
Title | Professor |
Telephone | +82-2-2258-6052 |
Affiliation | The Catholic University of Korea, Seoul St. Mary's Hospital |
Address | 222 Banpo-daero, Seocho-gu, Seoul |
Contact Person for Public Queries | |
Name | Nayoun Kim |
Title | Production Director |
Telephone | +82-2-532-2520 |
Affiliation | LucasBio |
Address | 222 Banpo-daero, Seocho-gu, Seoul |
Contact Person for Updating Information | |
Name | Nayoun Kim |
Title | Production Director |
Telephone | +82-2-532-2520 |
Affiliation | LucasBio |
Address | 222 Banpo-daero, Seocho-gu, Seoul |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-01-01 Anticipated | |
Target Number of Participant | 36 | |
Primary Completion Date | 2024-01-31 , Anticipated | |
Study Completion Date | 2025-03-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | The Catholic University of Korea, Seoul St. Mary's Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-01-01 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | The Catholic University of Korea, Yeouido St. Mary's Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-02-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Celltrion Pharm |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, Seoul St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Objective: To evaluate the safety and efficacy in elderly, high risk DLBCL patients who respond to primary R-CHOP treatment, and receive maintenance therapy with rituximab and cytokine-induced killer cells. Safety is evaluated by observing any adverse reactions and signs that may occur after maintenance therapy. Efficacy is evaluated through 2-year disease-free survival Background: Although elderly patients, as in majority of patients, with advanced lymphoma are expected to be treated only by immunochemotherapy, thorough evaluation and caution are needed to determine whether they are suitable for standard therapy or prevent recurrence, The decision is tricky because most elderly patients are unable to receive appropriate treatment regimens and thus lower dose therapies are provided in which leads to a high recurrence rate. Even if all anticancer therapies are completed, intensive supportive care is required which includes antiviral therapy and anti-infective agents to alleviate the toxic effects of chemotherapy. Therefore, elderly patients with advanced lymphoma have high rates of recurrence-related mortality as well as high rates of cancer-related mortality. - Currently, elderly patients cannot use consolidation therapy such as radiation therapy, autologous stem cell transplantation or additional chemotherapy. Therefore, in the absence of adequate maintenance therapy for elderly patients who have received primary chemotherapy, immune cell therapy which has low toxicity and high anti-tumor effects can be used in combination with targeted antibody therapy to achieve long-term remission Hypothesis: Immune cell therapy has been continuously developed in pre-clinical and clinical studies. It is known for their high anti-tumor effects and absence of adverse effects, sot it may be feasible and reproducible even in elderly patients. Although targeted antibody therapy can directly bind and kill the tumor cells, the antibody-conjugated tumor cells can also be recognized by killer cells existing in the immune system. Therefore, there is a strong rationale for combining cytokine-induced killer cells with targeted antibodies. Clinical research plan: The clinical trial will be conducted with subjects who voluntarily consented to participating in the trial. In the subjects who received the first R-CHOP treatment and showed complete response will be further determined whether they are suitable for the selection/exclusion criteria, and then subjects will be randomly assigned to the experimental group and compared with a 1:1 ratio. Randomization and blood collection for the trial group will be completed at least 21 days prior to the first administration. Only subjects randomly assigned to the test group will be collected for 250 cc of blood for CIK culture. The collected blood goes through a cell culture process for 3 weeks at the GMP facility of the Cell Therapy Project Group at St. CIK cells (autologous-CIK cells; auto CIK cells) and will be injected intravenously. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1/Phase2 |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug, /Biological/Vaccine, /Non-Stem Cell |
Intervention Description | Rituximab + autologous CIKcells 1. Rituximab treatment 1) Dose: Mix in 500mL of normal saline and inject 375mg/㎡ intravenously 2) Administration route: intravenous injection 2. Autologous CIK cells (auto CIK cells) 1) Dose: The number of cells can range from 1x10e9 to 1x10e10 and is provided in a 100mL normal saline bag and is injected intravenously for 30 minutes 2) Administration route: intravenous injection Frequency and duration of administration: total of 4 doses every 3 months |
Number of Arms | 2 |
Arm 1 |
Arm Label Rituximab+CIK combination therapy |
Target Number of Participant 18 |
|
Arm Type Experimental |
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Arm Description Rituximab + autologous CIKcells 1. Rituximab treatment 1) Dose: Mix in 500mL of normal saline and inject 375mg/㎡ intravenously 2) Administration route: intravenous injection 2. Autologous CIK cells (auto CIK cells) 1) Dose: The number of cells can range from 1x10e9 to 1x10e10 and is provided in a 100mL normal saline bag and is injected intravenously for 30 minutes 2) Administration route: intravenous injection Frequency and duration of administration: total of 4 doses every 3 months |
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Arm 2 |
Arm Label No treatment |
Target Number of Participant 18 |
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Arm Type No intervention |
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Arm Description No treatment(Observational) |
9. Subject Eligibility
Condition(s)/Problem(s) |
(D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
diffuse large B cell lymphoma |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 65Year~No Limit |
|
Description 1) Patients over 65 years of age 2) Elderly DLBCL patients with complete response (CR) to the first-line R-CHOP therapy 3) Patients whose LDH level is higher than the normal range for each laboratory at the time of initial diagnosis 4) Ann arbor Advanced stage (stage III, IV) or bulky disease 5) ECOG performance evaluation 0, 1, 2 factors 6) Patients within 6 months of receiving the first R-CHOP therapy 7) Those who are judged to be able to survive more than 3 months 8) Patients who satisfy the following in the blood test 9) White blood cell count ≥ 3.0 109/L (103/uL) 10) Platelet count ≥ 750/109/L (103/uL) 11) Total bilirubin in serum ≤ 2 times the normal upper limit of each laboratory 12) Serum liver enzyme levels (transaminases, AST, ALT) ≤ 3 times the normal upper limit of each laboratory 13) Patients who did not receive other immunotherapy 14) Patients without tuberculosis infection within 6 months 15) Those who agree to participate in this clinical trial and have consented in writing |
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Exclusion Criteria |
1) Pregnant, lactating or pregnant women or women who have not taken adequate contraceptive measures 2) For men who are sexually active with women of childbearing age, men who do not take appropriate contraception (a double-blocking method that uses a male condom and a cervical cap or under a contraceptive diaphragm and additional spermicide) 3) Patients with active infection or fever (≥ 38℃) of unknown etiology or ongoing bacterial or fungal infection 4) HIV, HBV, HCV positive patients 5) Subjects with cancer history within 5 years 6) Uncontrolled hypertension (diastolic blood pressure> 115 mmHg) 7) unstable angina or congestive heart failure (NY class II or higher) 8) Severe diabetes that is poorly controlled 9) Those who have undergone coronary angioplasty within the last 6 months 10) Patients with non-malignant diseases including acute myocardial infarction or uncontrolled atrial or ventricular arrhythmia within the last 6 months 11) Mental disorder patients, drug addiction 12) Those who participated in other clinical trials within 30 days before registration 13) Those who judge that the investigator is unsuitable for participation in the clinical trial |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | 2 year disease free survival |
|
Timepoint | At 24 months after treatment |
|
Primary Outcome(s) 2 | ||
Outcome | Incidence of adverse reactions of NCI grade 3 or higher |
|
Timepoint | 0d, 1d, 3M, 6M, 9M, 12M, 15M, 18M, 21M, 24M (on the day and day following injection and every three months for 2 years) |
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Secondary Outcome(s) 1 | ||
Outcome | 2 year progression free survival |
|
Timepoint | At 24 months after treatment |
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Secondary Outcome(s) 2 | ||
Outcome | Tumor response (complete response or partial response) |
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Timepoint | 0D, 3M, 6M, 9M, 12M, 15M, 18M, 21M, 24M (Every 3 months for 2 years) |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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