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Diffuse Large B Cell LymphomaPhase 2NCT03837873

DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

A Phase 2 study testing Rituximab, Etoposide and Vincristine in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Rituximab, Etoposide and Vincristine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
6 sitesChina
Study dates
21 Jan 2019to 1 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmed aggressive B-cell lymphoma with one of the following subtypes:
  • diffuse large B-cell lymphoma, NOS with at least one poor prognostic factor as follows:
  • aaIPI 2~3(≤60 years) or IPI 3~5(>60 years);
  • double protein expression lymphoma(IHC MYC≥40% and BCL2≥50%） with Ann Arbor stage of III~IV or aaIPI 2~3 or IPI 3~5;
  • CD5+ DLBCL.
  • high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;
Show all 11Show fewer
  • high-grade B-cell lymphoma, NOS
  • transformed lymphoma(no prior treatment)
  • Age 18 to 65 years
  • ECOG-PS: 0~2
  • Life-expectancy > 3 months

Who cannot join

  • Patients with central nerves system involvement
  • HIV positivity

Trial locations and contacts

6 sites in 1 country.

Wei Liu, Dr. contact

+86-020-23909282

liuwei@ihcams.ac.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • the First Affiliated Hospital of Jilin University

    Changchun, Jilin

    Fengyan Jin, Dr.

    Fengyan Jin, Dr.

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Hui Zhou, Dr.

    Hui Zhou, Dr.

    Not yet recruiting

  • the Second Hospital of Dalian Medical University

    Dalian, Liaoning

    Xiaobo Wang, Dr.

    Xiaobo Wang, Dr.

    Not yet recruiting

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Fei Li, Dr.

    Fei Li, Dr.

    Not yet recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong

    Ling Wang, Dr.

    Ling Wang, Dr.

    Not yet recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

    Wei Liu, Dr., 86-022-23909282, liuwei@ihcams.ac.cn

    Dehui Zou, Dr.

    Recruiting

Other trials in China

About this study

Official title: DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Read the detailed description

Survival for patients with high risk aggressive B-cell lymphoma is still unsatisfied. Dose-intensified immunochemotherapy might improve the outcome. But for patients who could not achieve CR after the dose-intensified induction therapy, the prognosis is poor. The DLCL002 protocol is a total therapy which including induction therapy, rescue therapy and autologous stem cell transplantation. Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

Study groups in NCT03837873
Study groupRoleWhat they receive
DLCL002 protocolExperimentalPatients will receive R-DA-EDOCH(rituximab, etoposide, dexamethasone, vincristine, cyclophosphamide, doxorubicin) as induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP(rituximab, lenalidomide(only for patients with non-GCB DLBCL), dexamethasone, cisplatin, cytarabine). Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments.
Receives: Drug: Rituximab; Drug: Etoposide; Drug: Vincristine; Drug: Doxorubicin; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Lenalidomide; Drug: Cisplatin; Drug: Cytarabine

What is being measured

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

  1. PFS

    progression free survival

    Measured: From the date of the start of treatment until the date of first documented progression, relapse or death from any cause, whichever came first, assessed up to 2 years.

Secondary outcomes (4)

  1. ORR

    objective response rate

    Measured: up to 3 months after the end of the therapy

  2. EFS

    event free survival

    Measured: From the date of the start of treatment until the date of the first adverse event (i.e. disease progression, relapse, diagnosis of a secondary malignancy, institution of a new anticancer treatment, any cause of death), assessed up to 2 years.

  3. OS

    overall survival

    Measured: From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.

  4. CRR

    complete response rate

    Measured: up to 3 months after the end of the therapy

Timeline

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

  1. First posted12 Feb 2019
  2. Study start21 Jan 2019
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837873
Sponsor's protocol ID
IIT2018010-EC-2
Status last verified
Jan 2022
First submitted
5 Jan 2019
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Etoposide and Vincristine in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 6 sites 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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 phase mean?

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?

Results are not available in the source record.

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

Contact Wei Liu, Dr. (+86-020-23909282, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From the date of the start of treatment until the date of first documented progression, relapse or death from any cause, whichever came first, assessed up to 2 years.). 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 NCT03837873.

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 26 Jan 2022.

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