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

June 13, 2020 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

A Phase II, Prospective, Single-center Study of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.
  2. ECOG PS 0-2
  3. Age 18-60 years old
  4. Expected survival ≥ 12 weeks
  5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
  6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
  2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
  3. Previous exposure to any anti-tumor therapy
  4. 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
  5. History of DVT or PE within past 12 months
  6. 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
  7. 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
  8. CNS or meningeal involvement
  9. Known sensitivity or allergy to investigational product
  10. Major surgery within three weeks
  11. Patients receiving organ transplantation
  12. 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
  13. Presence of Grade III nervous toxicity within past two weeks
  14. Active and severe infectious diseases
  15. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
  16. In any conditions which investigator considered ineligible for this study
  17. Patients with histological transformation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R2-DA-EPOCH
Drug: Lenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle
Drug: Rituximab
Rituximab 375 mg/m2，IV, d0
Drug: Etoposide
Etoposide 50 mg/m2/day CI24h d1-d4
Drug: Doxorubicin
Doxorubicin 10 mg/m2/day CI24h d1-d4
Drug: Vincristine
Vincristine 0.4mg/m2/day CI24h d1-d4
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2/day IV d5
Drug: Prednisone
Prednisone 60 mg/m2/bid oral or IV d1-d5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum tolerated dose and dose limited toxicity
Time Frame: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)
21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)
Overall response rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
from the date of inclusion to date of death, irrespective of cause
2 years
Progressive free survival
Time Frame: 2 years
from date of inclusion to date of progression, relapse, or death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 9, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 13, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-SR-430

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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