Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
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ClinicalTrials.gov Identifier: NCT04432714 |
Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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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 |
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 |

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 |
- maximum tolerated dose and dose limited toxicity [ Time Frame: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days) ]
- Overall response rate [ Time Frame: 6 months ]
- Progressive free survival [ Time Frame: 2 years ]from date of inclusion to date of progression, relapse, or death from any cause
- 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 |
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.

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
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 |
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 |
Principal Investigator: | Wei Xu, M.D., Ph.D | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
DLBCL MYC Gene rearrangement Lenalidomide R-DA EPOCH |
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 |