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New treatment option for Diffuse Large B-cell Lymphoma
Official title R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse
ClinicalTrials.gov ID: NCT05257018
What this study is testing
What is R-CDOP+intrathecal MTX?
R-CDOP+intrathecal MTX is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diffuse large b-cell lymphoma.
Also referred to as Pegylated liposome doxorubicin（PLD）.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-center, single-arm, phase 2 study to evaluate the efficacy and safety of R-CDOP regimen combined with intrathecal methotrexate in chemo-naive diffuse large B-cell lymphoma patients with high-risk of CNS relapse.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age range from 18 to 75 years;
- ECOG performance status: 0-2;
- Histopathologically confirmed untreated diffuse large B-cell lymphoma (cell origin can be distinguished according to Hans algorithm) , And fulfilled...
- CNS-IPI 4-6;
- The lymphoma involved testis, breast (excluding unilateral breast and less than 5 cm mass), adrenal gland, kidney, paranasal sinus, paravertebral...
You likely can't join if
- Patients with a known history of severe allergy to humanized or murine mAbs, or any contraindication to R-CDOP, intrathecal MTX;
- Patients with evidence of CNS involvement (baseline cerebrospinal fluid, imaging, symptoms);
- Special types of diffuse large B-cell lymphoma patients who are not suitable for induction therapy with R-CDOP, such as PMBCL, double-hit large...
- Clinically significant cardiac conditions, including severe cardiac insufficiency: New York Heart Association (NYHA) cardiac insufficiency class IV...
- Those who had a second degree or greater operation within three weeks before treatment;
- Diagnosed with a malignancy other than lymphoma or under treatment, with the following exceptions:
See the full eligibility criteria
- Age range from 18 to 75 years;
- ECOG performance status: 0-2;
- Histopathologically confirmed untreated diffuse large B-cell lymphoma (cell origin can be distinguished according to Hans algorithm) , And fulfilled the following criteria for high-risk CNS recurrence:
- CNS-IPI 4-6;
- The lymphoma involved testis, breast (excluding unilateral breast and less than 5 cm mass), adrenal gland, kidney, paranasal sinus, paravertebral, and bone marrow and other sites;
- PCLBCL-leg;
- people have at least one measurable lesion: the long axis of the lymph node shall be\>1.5 cm, the long axis of the extranodal lesions shall be\>1.0 cm;
- Bone marrow hematopoiesis was essentially normal: WBC≥3.5 ×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥90 g/L. Abnormal peripheral blood indices, as a result of lymphoma invading the bone marrow or spleen, permitted...
- Liver function: total bilirubin, ALT, AST \< 1.5×UNL (upper limit of normal);
- Renal function: Cr \< 1.5×UNL and creatinine clearance≥30 ml/min;
- Echocardiography or nuclide cardiac function testing with LVEF≥50%;
- Patients in the reproductive period agreed to appropriate contraception. Women in the reproductive period had a negative serum pregnancy test within 2 weeks before enrollment;
- Consent to provide pathological tissue specimens (wax blocks within half a year or 20 slides for paraffin tissue sections);
- Life expectancy≥3 months;
- Signed informed consent;
- Patients with a known history of severe allergy to humanized or murine mAbs, or any contraindication to R-CDOP, intrathecal MTX;
- Patients with evidence of CNS involvement (baseline cerebrospinal fluid, imaging, symptoms);
- Special types of diffuse large B-cell lymphoma patients who are not suitable for induction therapy with R-CDOP, such as PMBCL, double-hit large B-cell lymphoma, etc;
- Clinically significant cardiac conditions, including severe cardiac insufficiency: New York Heart Association (NYHA) cardiac insufficiency class IV, unstable angina, acute myocardial infarction within 6 months prior to...
- Those who had a second degree or greater operation within three weeks before treatment;
- Diagnosed with a malignancy other than lymphoma or under treatment, with the following exceptions:
- Had received treatment with curative intent and had not developed malignancy with known active disease ≥ 5 years prior to enrollment;
- Basal cell carcinoma of the skin (other than melanoma) that has been adequately treated with no evidence of disease;
- Carcinoma in situ of the cervix that has been adequately treated with no evidence of disease;
- Had significant coagulation abnormalities;
- Any previous antilymphoma therapy other than short-term corticosteroids (up to 10 days);
- Those with severe active infection;
- Other serious, uncontrolled concomitant conditions that may affect protocol adherence or interfere with interpretation of results include uncontrolled diabetes mellitus, or pulmonary disease (interstitial pneumonia...
- HBV (HBsAg positive and HBV-DNA ≥ 104 IU / ml), HCV (HCV antibody positive and HCV-RNA measurable); And people with other acquired, congenital immunodeficiency diseases, including but not limited to those with HIV...
- Pregnant or lactating women;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Ürümqi, Xinjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Ürümqi, Xinjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.