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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432714
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
DLBCL Untreated MYC Gene Rearrangement Drug: Lenalidomide Drug: Rituximab Drug: Etoposide Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide Drug: Prednisone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
Estimated Study Start Date : June 9, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432714


Contacts
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Contact: Li Wang, M.D., Ph.D 86 25 68306034 lilyw7878@163.com
Contact: Wei Xu, M.D., Ph.D 86 25 68306034 xuwei10000@hotmail.com

Locations
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China, Jiangsu
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Li Wang, M.D., Ph.D    86 25 68306034    lilyw7878@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Wei Xu, M.D., Ph.D The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Publications:
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Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04432714    
Other Study ID Numbers: 2019-SR-430
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WEI XU, The First Affiliated Hospital with Nanjing Medical University:
DLBCL
MYC Gene rearrangement
Lenalidomide
R-DA EPOCH
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Etoposide
Vincristine
Lenalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors