Clinical trials for HDC / ASCT indication rrDLBCL

JRCT ID: jRCTs071210121

Registered date:26/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or recurrent diffuse large B-cell lymphoma
• Date of first enrollment: 26/01/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Rituximab 375 mg / m2 is administered intravenously on the 1st day and bendamustine hydrochloride 120 mg / m2 / day is intravenously administered on the 2nd and 3rd days. After that, the drug holiday will be 18 days, and this will be one cycle. If a response is obtained in 2 cycles, after administration in 3 cycles, mobilize and collect hematopoietic stem cells with a combination of prelyxaform / G-CSF, and after the 4th cycle, proceed to HDC / ASCT. HDC / ASCT is given high-dose chemotherapy at the discretion of the investigator. The starting time, conditioning regimen and ASCT protocol are at the discretion of the physician.

Outcome(s)

• Primary Outcome: [Revised Response Criteria for Malignant Lymphoma(2007)]Relief Chemotherapy Corrected response rate for the percentage of patients who successfully collected hematopoietic stem cells after 3 cycles

Secondary Outcome

1.Complete response rate assessed by[Revised Response Criteria for Malignant Lymphoma(2007)] after the salvage therapy up to 2cycle
2.Overall Response Rate assessed by[Revised Response Criteria for Malignant Lymphoma(2007)] after the salvage therapy up to 2cycle
3.The rate of patients who were able to harvest 2x106cells/kg of CD34-positive cell within 2 days after apheresis
4.Number of days it took to harvest over 2x106cells/kg of CD34-positive cell

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1. Patients (excluding transformed lymphoma) who have been confirmed to have diffuse large B-cell lymphoma (DLBCL, NOS) by central histopathological examination (WHO classification revised 4th edition, 2017).
2. Patients whose tumor cells have been confirmed to be CD20 positive by immunohistochemical staining or flow cytometry.
3. Patients with relapsed or relapsed DLBCL who have progressed after standard R-CHOP therapy or similar treatment as first-line treatment.
4. Patients who wish to have HDC / ASCT.
5. Patients with measurable lesions (major axis by CT:) 1.5 cm).
6. Patients who can be expected to survive for at least 3 months or more.
7. Patients aged 20 years or older at the time of consent.
8. Patients aged 70 years or younger at the time of case registration.
9. Patients with Performance Status (P.S.) 0-2.
10. Patients with 6 months or more from pretreatment to recurrence or relapse.
11. Patients with sufficient function of major organs (bone marrow, heart, lungs, liver, kidneys, etc.).
- Neutrophil number: 1,500 /mm3 or more.
- Platelet count: 100,000 / mm3 or more.
- AST (GOT): Less than 2.5 times the upper limit of the standard value of each facility.
- ALT (GPT): Less than 2.5 times the upper limit of the standard value of each facility.
- Total bilirubin: less than 1.5 times the upper limit of the standard value of each facility.
- Percutaneous arterial oxygen saturation SpO2>= 95% or arterial oxygen partial pressure PaO2>=65 mmHg.
-There are no abnormal findings on the electrocardiogram that require treatment.
-Echocardiographic left ventricular ejection fraction (LVEF): 55% or higher.
12. Patients who have voluntarily agreed to participate in this study.

Exclude criteria

1.Patients who had been without treatment for less than 3 weeks after prior treatment (radiation therapy, antibody therapy, and cancer chemotherapy including corticosteroid (oral/injection only)monotherapy for the purposes of antitumor effect).
2.Patients who are not eligible for HDC/ASCT at the time of obtaining informed consent.
3.Patients who have received salvage therapy and/or HDC/ASCT in the past.
4.Patients who are judged to have difficulty in performing rescue chemotherapy by combining two or more anticancer chemotherapeutic agents due to medical reasons such as aging, decreased organ function, and comorbidities.
5.Patients who have not responded better than PR to any of the treatments given in the past.
6.Patients with a pretreatment history of 3 or more regimens.
7.Patients with infiltration of the central nervous system or clinical symptoms suspected of it.
8.Patients with severe active infections (requiring intravenous administration of antibiotics, antifungals or antivirals).
9.Patients with serious liver disease such as cirrhosis.
10.Patients with moderate or higher renal impairment (creatinine clearance 50 ml / min or less).
11.Patients with complications or history of serious heart disease (eg, myocardial infarction, ischemic heart disease). However, for arrhythmia, registration is possible if treatment is not required at the time of registration.
12.Patients with severe gastrointestinal symptoms (such as severe or grave nausea / vomiting or diarrhea).
13.Patients with malignant pleural effusion, pericardial effusion or ascites retention.
14. Patients showing HBsAg, HCV antibody or HIV antibody positive (HBsAg negative and HBsAg or HBc antibody positive, HBV-DNA measured and positive. HCV antibody positive, HCV-RNA Patients who measure positive).
15. Patients with severe bleeding tendency (such as disseminated intravascular coagulation (DIC)).
16. Patients with interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease, or previously observed patients.
17. Patients with active double cancer or a history of other malignancies within the last 5 years. However, basal cell carcinoma of the skin, squamous cell carcinoma or carcinoma in situ of the cervix is excluded.
18. Patients with or previously observed autoimmune hemolytic anemia.
19. Patients who have previously received bendamustine hydrochloride.
20. Patients who received or transfused cytokine preparations such as G-CSF and erythropoietin within 2 weeks before the test at the time of enrollment in this study.
21.Patients who received the drug under study or unapproved drug within 3 months prior to enrollment in this study.
22.Patients who have been allergic to drugs similar to this study drug (alkylating agents, purine nucleoside derivatives) in the past.
23.Patients who have had a serious reaction such as hypersensitivity to bendamustine hydrochloride, prelixaform or filgrastim in the past.
24.Patients with rituximab resistance or intolerance.
25.Patients who have previously undergone allogeneic hematopoietic stem cell transplantation.
26.Patients who have received radioimmunotherapy in the past.
27.Pregnant or potentially pregnant patients, lactating patients.
28.Patients who cannot consent to contraception during administration and for 6 months after the end of administration for men, and for women during administration and for 3 months after the end of administration for women.
29.Patients who cannot receive pretreatment drugs due to drug allergies.
30.Other patients who are judged to be inappropriate by the principal investigator or the investigator.

Related Information

• Primary Sponsor: Terui Yasuhito
• Secondary Sponsor: SymBio Pharmaceuticals Limited