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Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

ConditionsDLBCLUntreatedMYC Gene Rearrangement
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.

ECOG PS 0-2

Age 18-60 years old

Expected survival ≥ 12 weeks

Disqualifiers

Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures

Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons

Previous exposure to any anti-tumor therapy

Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma

Trial design

Design model

Single group

Treatments tested in this trial

  • Lenalidomide

    Drug

    Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle

  • Rituximab

    Drug

    Rituximab 375 mg/m2，IV, d0

  • Etoposide

    Drug

    Etoposide 50 mg/m2/day CI24h d1-d4

  • Doxorubicin

    Drug

    Doxorubicin 10 mg/m2/day CI24h d1-d4

  • Vincristine

    Drug

    Vincristine 0.4mg/m2/day CI24h d1-d4

  • Cyclophosphamide

    Drug

    Cyclophosphamide 750 mg/m2/day IV d5

  • Prednisone

    Drug

    Prednisone 60 mg/m2/bid oral or IV d1-d5

Treatment groups

81 Participants
are divided into 1 treatment group
Group A: R2-DA-EPOCHExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

maximum tolerated dose and dose limited toxicity

Time frame
21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)
2

Overall response rate

Time frame
6 months

Secondary outcomes

1

Progressive free survival

from date of inclusion to date of progression, relapse, or death from any cause

Time frame
2 years
2

Overall survival

from the date of inclusion to date of death, irrespective of cause

Time frame
2 years

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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