Clinical trial · Interventional

Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

The Efficacy and Safety of Zanubutinib-based for Post-remission Maintenance in Patients With Diffuse Large B-cell Lymphoma Who Are Intolerant to Intense First-line Chemotherapy

NCT06669143CI-TRIAL-00082144not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Diffuse Large B Cell Lymphoma	Diffuse Large B-Cell Lymphoma	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Lenalidomide	Drug	Lenalidomide	ALIAS
Zanubrutinib	Drug	Zanubrutinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Zanubrutinib and Lenalidomide
interventionNames
1. Drug: Zanubrutinib
2. Drug: Lenalidomide

Primary outcomes (1)

measure
2-year recurrence-free survival
timeFrame
2 years after enrollment

Secondary outcomes (3)

measure
Overall survival
timeFrame
From enrollment to study completion, a maximum of 4.5 years
description
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients were informed about this study and voluntarily signed written informed consent
2. Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
3. DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
4. Life expectancy \> 3 months
5. Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
6. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.

Exclusion Criteria:

1. Contraindication to any drug in the study
2. Seropositive for or active viral infection with HBV or HCV
3. Human immunodeficiency virus (HIV) infection
4. Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
5. QTc (corrected by Fridericia formula): \>480ms;
6. Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
7. If female, the patient is pregnant or breast-feeding
8. Any uncontrolled active systemic infection

References

Publications (0)

Data not yet available

No reference posted for this study.