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NCT Number: NCT04432714

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Li Wang, M.D., Ph.D

CONTACT

[email protected]

86 25 68306034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
  • Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

  • 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
  • History of DVT or PE within past 12 months
  • Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
  • New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
  • CNS or meningeal involvement
  • Known sensitivity or allergy to investigational product
  • Major surgery within three weeks
  • Patients receiving organ transplantation
  • Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
  • Presence of Grade III nervous toxicity within past two weeks
  • Active and severe infectious diseases
  • Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
  • In any conditions which investigator considered ineligible for this study
  • Patients with histological transformation.

Treatment and study plan

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

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

    Time frame: 2 years

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

  2. Overall survival

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Li Wang, M.D., Ph.D

CONTACT

[email protected]

86 25 68306034

Wei Xu, M.D., Ph.D

CONTACT

[email protected]

86 25 68306034

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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