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RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL

ConditionDouble-expressor Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorZhejiang Cancer Hospital

About this trial

This is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Untreated DLBCL patients confirmed by histopathology 2. Immunohistochemistry showed positive expression of MYC and BCL2 protein (double expressor lymphoma, MYC≥40%, BCL2≥50%) 3. age over 70 years old or age ≥65 years old and ECOG score ≥2 points, both male and female 4. Having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter > 1.5 cm, or at least one extranodal lesion with a maximum diameter > 1.0 cm, and at least two vertical diameters that can be accurately measured.

Disqualifiers

1. The pathological subtypes were PCNSL, PMBCL, EBV-positive DLBCL and HGBL 2. Hemophagocytic syndrome accompanied the diagnosis 3. Central nervous system involvement is secondary to lymphoma 4. Are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. HIV infection 6. Major surgery was performed within 28 days prior to study start 7. Any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. The patients considered by the investigator to be unsuitable for participating in this study

Trial design

Design model

Single group

Treatments tested in this trial

  • RLC-CRCHOP

    Drug

    Introduction treatment: Rituximab, lenalidomide, chidamide for 2 cycles: rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-14, chidamide 20mg, d1,4,8,11. Immunochemtherapy phase: CR CHOP for 4 cycles: chidamide 20mg d1,4,8,11,rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/ m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5. maintenance treatment period: chidamide d1,4,8,11

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: RLC-CRCHOPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression Free Survival

Time frame
From date of first day of treatment until the date of first documented date of disease progression or death from any cause, assessed up to 24 months

Secondary outcomes

1

ORR

overall response rate

Time frame
21days after the end of treatment
2

CRR

complete response rate

Time frame
21days after the end of treatment
3

OS

Overall Survival

Time frame
: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
4

AE and SAE

Adverse event and serious adverse event

Time frame
From date of first day of treatment until 30 day after last treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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