Recruiting PHASE2 DLBCL - Diffuse Large B Cell Lymphoma

New treatment option for DLBCL - Diffuse Large B Cell Lymphoma

Official title Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL

ClinicalTrials.gov ID: NCT06151080

What this study is testing

What is Lenalidomide combined with G-CHOP (LO CHOP)?

Lenalidomide combined with G-CHOP (LO CHOP) is an investigational medicine, being studied as a potential treatment for dlbcl - diffuse large b cell lymphoma.

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
To evaluate the efficacy and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
  • 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 70

You may be able to join if

  • Age: 18-70 years old, gender is not limited;
  • According to the REAL/WHO classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (CDLBCL-FL): the same lymph node...
  • Using the Lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: PET/CT can evaluate the...
  • ECOG 0-2
  • Left ventricular ejection fraction (LVEF) was less than 45%

You likely can't join if

  • DLBCL of primary and secondary centers;
  • HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing)
  • Clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure\>115 mmHG), uncontrolled...
  • Severe chronic obstructive pulmonary disease complicated with hypoxemia.
  • Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy
  • Except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early...
See the full eligibility criteria
Who can join
  • Age: 18-70 years old, gender is not limited;
  • According to the REAL/WHO classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (CDLBCL-FL): the same lymph node specimen showed diffuse large b-cell lymphoma and follicular...
  • Using the Lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: PET/CT can evaluate the lesion, CT or MRI can evaluate the lesion in the node with a diameter...
  • ECOG 0-2
  • Left ventricular ejection fraction (LVEF) was less than 45%
  • HBV-positive serology (occult carriers: anti-HBeAg +, anti-HBsAg-, anti-HBsAg +/-) can only be enrolled if the HBV-dna test is negative.
  • Normal major organ function: liver function: serum bilirubin ≤2.0 × ULN, serum ALT and AST ≤2.5 × ULN, renal function: serum CR ≤2.0 × ULN; (unless caused by lymphoma)
  • Absolute neutrophil count (ANC)≥1.0 × 109 l, platelet count (PLT)≥100 × 109 L, hemoglobin content (HGB)≥80 g L, if myeloma was involved, ANC ≥0.75 × 109 L, platelet count (PLT)≥50 × 109 L, HGB content (HGB) was not...
  • Life expectancy ≥6 months
  • Informed consent (all studies had to sign a patient's informed consent form)
What rules you out
  • DLBCL of primary and secondary centers;
  • HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing)
  • Clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure\>115 mmHG), uncontrolled arrhythmias, symptomatic angina pectoris, or NYHA III-IV congestive heart...
  • Severe chronic obstructive pulmonary disease complicated with hypoxemia.
  • Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy
  • Except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early breast cancer only requires surgery. Other malignant tumors have...

The study team makes the final eligibility decision.

Where it's taking place

  • Xiamen, Fujian, 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 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Xiamen, Fujian, 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.