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Diffuse Large B Cell LymphomaPhase 2NCT04025593

Biomarker Guided Treatment in DLBCL

A Phase 2 study testing Cyclophosphamide, Rituximab and Doxorubicin in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Cyclophosphamide, Rituximab and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteChina
Study dates
17 Jul 2019to 1 Jun 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
  • ECOG 0,1,2
  • Life expectancy>6 months
  • Informed consented
  • IPI>1

Who cannot join

  • Chemotherapy before
  • Stem cell transplantation before
  • History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary CNS lymphoma
  • LVEF≤50%
  • Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Trial locations and contacts

1 site in 1 country.

WL Z, MD PhD contact

64370045 ext. 610707

zhao.weili@yahoo.com

China1 site, 1 recruiting

  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

    Pp X, MD, PhD, 86-21-64370045 ext. 610707, xpproc@msn.com

    WL Z, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma

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 NCT04025593
Study groupRoleWhat they receive
RCHOPActive comparatorNot described
Receives: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
RCHOPXExperimentalNot described
Receives: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Ibrutinib; Drug: Lenalidomide; Drug: chidamide; Drug: decitabine

What is being measured

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

  1. complete response rate

    Measured: 21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary outcomes (4)

  1. progression free survival

    Measured: 2 year

  2. overall survival

    Measured: 2 year

  3. overall response rate

    Measured: 21 days after 6 cycles of treatment (each cycle is 21 days)

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Measured: Up to 30 days after completion of study treatment

Timeline

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

  1. First posted19 Jul 2019
  2. Study start17 Jul 2019
  3. Primary completion1 Jul 2021 (estimated)
  4. Study completion1 Jun 2023 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025593
Sponsor's protocol ID
Guidance-01
Status last verified
Nov 2020
First submitted
17 Jul 2019
Last updated
19 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Rituximab and Doxorubicin in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital 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 5 inclusion and 7 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 19 Nov 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 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 WL Z, MD PhD (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate (time frame: 21 days after 6 cycles of treatment (each cycle is 21 days)). 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 NCT04025593.

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 19 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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