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Diffuse Large B Cell LymphomaPhase 1/2DR-CHOPNCT02951728

Decitabine Plus R-CHOP in Diffuse Large B-cell Lymphoma

A Phase 1/2 study testing Rituximab, Cyclophosphamide 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Rituximab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
Oct 2016to Oct 2020
Phase
Phase 1/2
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 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • histologically confirmed DLBCL, CD20 positive.
  • must have at least one site of measurable disease, 1.5 cm in diameter or greater.
  • has not had any previous treatment.
  • International Prognostic Index >1.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • must have laboratory test results within these ranges: Absolute neutrophil count ≥1500/mm3 Platelet count≥75,000/mm3 Serum creatinine≤1.5×upper limit of normal (ULN) Total bilirubin≤1.5×ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
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  • AST (SGOT) and ALT (SGPT) ≤2×ULN
  • Disease free of prior malignancies with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Women of childbearing potential must have a negative serum pregnancy test prior to Decitabine treatment.
  • Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with Decitabine. The effects of Decitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Age 15 to 75 years.
  • Ability to understand and the willingness to sign a written informed consent document.
  • ECOG performance status of 0-2

Who cannot join

  • Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV. 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.
  • Known central nervous system involvement by lymphoma.
  • Known or suspected hypersensitivity to Decitabine or mannitol.
  • Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Ruijin Hospital

    Shanghai, 20025

Other trials in China

About this study

Official title: Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma

This is a Phase I/II Trial of Decitabine + R-CHOP 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 NCT02951728
Study groupRoleWhat they receive
Decitabine plus R-CHOPExperimentalRituximab 375 mg/m2 IV d6; Cyclophosphamide 750mg/m2 IV d7; Doxorubicin 50mg/m2 IV d7; Vincristine 1.4 mg/m2 IV d7; Prednisone 60 mg/m2 PO d7-11; Decitabine will be administered intravenously at dose levels as follow in Phase 1: Dose level 1: Decitabine 10 mg/m2 days 1-5; Dose level 2: Decitabine 15 mg/m2 days 1-5; Dose level 3: Decitabine 20 mg/m2 days 1-5 and determine the maximum tolerated dose. In phase 2, Decitabine will be administered intravenously at MTD.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Decitabine

What is being measured

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

  1. maximum tolerated dose

    The primary endpoint for the phase I portion of the study is to determine the maximum tolerated dose of Decitabine when given in combination with a standard dose (q21 day) regimen of R-CHOP in patients with DLBCL.

    Measured: day1 to 21

  2. complete response rate

    The primary endpoint for the phase II portion of the study will be complete response rate.

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

Secondary outcomes (5)

  1. Overall response rate

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

  2. Event-free survival

    Measured: 2 years

  3. Overall survival

    Measured: 2 years

  4. Progression-free survival

    Measured: 2 years

  5. 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 posted1 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMay 2019
  4. Study completionOct 2020 (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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02951728
Sponsor's protocol ID
DR-CHOP
Acronym
DR-CHOP
Status last verified
Mar 2020
First submitted
24 Oct 2016
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab, Cyclophosphamide 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 13 inclusion and 8 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 11 Mar 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (time frame: day1 to 21). 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 NCT02951728.

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 11 Mar 2020.

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