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DLBCLPhase 1/2NCT04432714

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

A Phase 1/2 study testing Lenalidomide, Rituximab and Etoposide in people with DLBCL and Untreated, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
DLBCL, Untreated, MYC Gene Rearrangement
What is being tested?
Lenalidomide, Rituximab and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteChina
Study dates
9 Jun 2020to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Wang, M.D., Ph.D contact

86 25 68306034

lilyw7878@163.com

Wei Xu, M.D., Ph.D contact

86 25 68306034

xuwei10000@hotmail.com

China1 site, 1 recruiting

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

    Nanjing, Jiangsu, 210029

    Li Wang, M.D., Ph.D, 86 25 68306034, lilyw7878@163.com

    Recruiting

Other trials in China

About this study

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

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.

Keywords
DLBCL, MYC Gene rearrangement, Lenalidomide, R-DA EPOCH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04432714
Study groupRoleWhat they receive
R2-DA-EPOCHExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Rituximab; Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose and dose limited toxicity

    Measured: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)

  2. Overall response rate

    Measured: 6 months

Secondary outcomes (2)

  1. Progressive free survival

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

    Measured: 2 years

  2. Overall survival

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start9 Jun 2020 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432714
Sponsor's protocol ID
2019-SR-430
Status last verified
Jun 2020
First submitted
11 Jun 2020
Last updated
16 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Godfrey JK, Nabhan C, Karrison T, Kline JP, Cohen KS, Bishop MR, Stadler WM, Karmali R, Venugopal P, Rapoport AP, Smith SM. Phase 1 study of lenalidomide plus dose-adjusted EPOCH-R in patients with aggressive B-cell lymphomas with deregulated MYC and BCL2. Cancer. 2019 Jun 1;125(11):1830-1836. doi: 10.1002/cncr.31877. Epub 2019 Feb 1.

    PubMed 30707764

  • Coiffier B, Sarkozy C. Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):366-378. doi: 10.1182/asheducation-2016.1.366.

    PubMed 27913503

  • Dunleavy K, Fanale MA, Abramson JS, Noy A, Caimi PF, Pittaluga S, Parekh S, Lacasce A, Hayslip JW, Jagadeesh D, Nagpal S, Lechowicz MJ, Gaur R, Lucas A, Melani C, Roschewski M, Steinberg SM, Jaffe ES, Kahl B, Friedberg JW, Little RF, Bartlett NL, Wilson WH. Dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) in untreated aggressive diffuse large B-cell lymphoma with MYC rearrangement: a prospective, multicentre, single-arm phase 2 study. Lancet Haematol. 2018 Dec;5(12):e609-e617. doi: 10.1016/S2352-3026(18)30177-7.

    PubMed 30501868

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Rituximab and Etoposide in people with DLBCL and Untreated, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Wang, M.D., Ph.D (86 25 68306034, lilyw7878@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432714, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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