NCT06750991Not yet recruitingPhase 2
CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)
A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI\>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 31 Dec 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06750991
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From 31 Dec 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Have previously received systemic or local treatment including chemotherapy;
- 2\. Previously received autologous stem cell transplantation;
- 8\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study.
Other illness
- 3\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
- 4\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
- 9\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- 11\. People living with HIV.
- 12\. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.
Lab values
- 6\. Left ventricular ejection fraction ≤ 50%;
- 7\. Laboratory test values at the time of screening (unless due to lymphoma); A. Neutrophils \<1.5\*109/L; B. Platelet \<75\*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal.
- Creatinine levels higher than 1.5 times the upper limit of normal
Other
- 5\. Primary central nervous system lymphoma;
- 10\. Pregnant or lactating women;
Who the study is looking for
- 1\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
- 2\. Pathologically confirmed a combination of TP53 mutation and del(17p);
- 3\. Age ≥ 18 years old, ≦75 years old;
- 4\. ECOG physical status score of 0, 1 or 2;
- 5\. No previous history of malignant tumors; No other tumors occurred simultaneously;
- 6\. Patients judged by the investigator to have a life expectancy of at least 6 months;
- 7\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
- 8\. International prognostic Index (IPI) \>1 score.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| No. 197 Ruijin 2nd Road, Huangpu District, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.