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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT04432714
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • DLBCL
  • MYC Gene Rearrangement
  • Untreated

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 9, 2020
Status verified
Jun 2020
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R2-DA-EPOCH

Primary Outcome Measure

maximum tolerated dose and dose limited toxicity [ Time Frame: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days) ]

Central Contacts

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