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Multicenter, randomized, open-label and parallel-group clinical study on the efficacy and safety of arsenic plus vitamin C combined with chemotherapy for treating relapsed and refractory B-cell non-Hodgkin lymphoma

Multicenter, randomized, open-label and parallel-group clinical study on the efficacy and safety of arsenic plus vitamin C combined with chemotherapy for treating relapsed and refractory B-cell non-Hodgkin lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003354
Enrollment
Unknown
Registered
2013-07-22
Start date
2013-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin lymphoma (B-cell)

Interventions

A:Regimen of DICE: Ifosfomide (1000mg/m2/day), carboplatin(120mg/m2/day) , etoposide (120mg/m2 /day), and dexamethasone (40mg/day) are injected from day 1 through day 4, and G-CSF (0.5µg/kg/day) is su
A:Regimen of DHAP:Carboplatin (120mg/m2/day) is injected from day 1 through day 3, and dexamethasone (40mg/day) from day 1 through day4, and cytarabine at a dosage of 2000mg/m2 is injected twice a day
B:Arsenic trioxide plus VitC combined with DICE regimen: Arsenic trioxide (0.16mg/kg/d) plus Vit C (1000mg/day) are injected from day1 through day 14. Regimen of DICE: Ifosfomide (1000mg/m2/day), carb
B :Arsenic trioxide plus VitC combined with DHAP regimen: Arsenic trioxide (0.16mg/kg/d) plus Vit C (1000mg/day) are injected from day1 through day 14. Regimen of DHAP:Carboplatin (120mg/m2/day) is in

Sponsors

Department of Hematology, the Second Affiliated Hospital of Dalian Medical University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The enrolled non-Hodgkin lymphoma patients should fulfill all the following requirements: 1. The enrolled subtypes of B-cell non-Hodgkin lymphoma include follicular lymphoma (Grade III), diffuse large B-cell lymphoma, and mantle cell lymphoma; 2. Need to reconfirm pathology diagnosis, and perform Immunohistochemistry staining of CD10, CD19+, CD20+, CD22+, CD79a+, CD5, BCL-6 and so on; 3. Ineffective treatment by two consecutive courses of front-line chemotherapy; 4. Relapsed after complete remission achieved by front-line chemotherapy; 5. Patients received regimens containing no platinum-based chemotherapy drugs; 6. Patients received regimens containing no arsenic trioxide; 7. ECOG score is 0, 1 or 2 before enrolled; 8. Enrolled patients aged 18 to 70 years; 9. The expected survival should be over 3 months; 10. No severe complications, such as renal insufficiency or cardiac insufficiency; 11. A female patient should be not pregnant, and she should consent to use appropriate contraceptive methods during treatment and follow-up for the next 1 year.

Exclusion criteria

Exclusion criteria: Patients should be excluded with any of the following items: 1. Non-B cell lymphoma should be excluded; 2. Afflicted with other malignancies in the past 5 years; 3. Experienced a major surgery except for surgical operations for diagnosis during past 4 weeks; 4. Complication of central nervous system leukemia (CNS-L); 5. Active hepatitis B infection, or positive antibody against hepatitis C virus; 6. Severe diseases which may constrain the enrollment, including a progressive infection, out-of-control diabetes, severe cardiac dysfunction or angina pectoris, hepatic or renal insufficiency, with 3- to 5- fold upper limit of normal range for GPT, GGT, or bilirubin, or creatinine clearance less than 50ml/min; 7. The expected survival will not be more than 3 months; 8. Administration of other therapeutic regimens 30 days before this enrollment; 9. Female APL patients during pregnant or lactation period, or without appropriate contraceptive methods; 10. Disapproval of this clinical trial by researchers.

Design outcomes

Primary

MeasureTime frame
Overall response rate;Overall survival (OS);Pregression-free survival, PF;

Secondary

MeasureTime frame
event-free survival;time to progression;disease-free survival;response duration;lymphoma-specific survival;time to treatment;

Countries

China

Contacts

Public ContactJin-Song Yan
yanjsdmu@gmail.com+86 13909863628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026