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Diffuse Large B Cell LymphomaPhase 2PTLDNCT02753062

Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma

A Phase 2 study testing bendamustine, rituximab in people with Diffuse Large B Cell Lymphoma, run by Asan Medical Center at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 an open-label, multi-center, prospective, single arm phase 2 trial of the combination of bendamustine and rituximab in patients with PTLD, monomorphic cluster of differentiation antigen 20(CD20) positive DLBCL. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
bendamustine, rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSouth Korea
Study dates
Aug 2015to Aug 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Histologically confirmed adult patients diagnosed with CD20-positive monomorphic PTLD, DLBCL irrespective of EBV association
  • Patients having undergone solid organ transplantation (heart, lung, liver, kidney, pancreas, small intestine transplantation, etc or a combination of the organ transplantations mentioned).
  • No prior treatment for PTLD, DLBCL except reduction of immunosuppression
  • At least one measurable lesion ≥ 1.5 cm in greatest transverse diameter by spiral CT
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
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  • Age ≥ 19
  • Adequate renal function: serum creatinine level < 2.0 mg/dL
  • Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver), bilirubin < 2 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver)
  • Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma. (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment).
  • Life expectancy 6 months
  • A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
  • Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 12 month thereafter; Males must use an effective method of birth control during treatment period and 12 months thereafter.

Who cannot join

  • Other subtypes PTLD than monomorphic CD20 (+) DLBCL
  • Previous treatment for PTLD, DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion (Low dose steroid as immunosuppressant are allowed.)
  • central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
  • Patients with a known history of HIV or HCV seropositivity.
  • Patients with active hepatitis B i. HBsAg positive or ii. HBsAg negative, anti-HBc-Ab positive and HBV-DNA PCR positive patients
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  • Pregnant or lactating women
  • Men who are not surgically sterile or women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions i. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months ii. History of significant neurological or psychiatric disorders including dementia or seizures iii. Active, uncontrolled infections requiring systemic antibiotic therapy or other serious infections within 14 days before study enrollment iv. Other serious medical illnesses
  • Known hypersensitivity to any of the study drugs or its ingredients
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.

Trial locations and contacts

1 site in 1 country.

Dok Hyun Yoon, M.D., PhD contact

82-10-3235-3090

dhyoon@amc.seoul.kr

Cheolwon Suh, M.D., PhD contact

82-10-3735-3209

csuh@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

    Dok Hyun Yoon, M.D.,Ph D, 82-10-3235-3090, dhyoon@amc.seoul.kr

    Cheolwon Suh, M.D.,Ph D, 82-10-3735-3209, csuh@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Multicenter Phase II Study of Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Type Monomorphic Post-transplant Lymphoproliferative Disorder

This is an open-label, multi-center, prospective, single arm phase 2 trial of the combination of bendamustine and rituximab in patients with PTLD, monomorphic cluster of differentiation antigen 20(CD20) positive DLBCL. The investigators want to investigate the efficacy and safety of the combination of bendamustine and rituximab in patients with previously untreated PTLD, monomorphic CD20 (+) diffuse large B-cell lymphoma.

Read the detailed description

Monomorphic PTLD comprise more than 70% of PTLDs and diffuse large B-cell lymphoma is the predominant subtype. However, none of the trials have been performed for the specific population of DLBCL type monomorphic PTLD. The investigators will select Patients with proven, measurable monomorphic PTLD of DLBCL after solid organ transplantation (e.g. heart, lung, liver or kidney etc.). Patients having PTLD with or without Epstein-Barr virus (EBV) association, positive for CD20 monomorphic DLBCL type. The B-R treatment will continue up to 6 cycles with interval of 21 days. Patients will receive 375 mg/m2 on day 1 and bendamustine 120 mg/m2 by intravenous infusion on day 2 and 3 in the first cycle. From the 2nd to 6th cycle, rituximab will be administered subcutaneously at a fixed dose of 1400 mg and bendamustine 120 mg/m2 by intravenous infusion on day 1 following administration of rituximab and day 2. On the first day of infusion of bendamustine in each cycle, palonosetron 0.25 mg will be given as a single intravenous injection about 30 minutes before infusion of bendamustine. Pegfilgrastim 6 mg will be administered as a single subcutaneous injection between 24 to 48 hours after completion of chemotherapy at each cycle. Based on relatively good safety profile and efficacy of bendamustine and rituximab (BR regimen), the investigators will investigate a feasibility of BR regimen in this immunocompromised patients with DLBCL type monomorphic PTLD.

Being tested
bendamustine, rituximab
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.

  • bendamustine, rituximabDrug

    Also called symbenda, mabthera

    subjects will receive rituximab 375mg/m2 on day 1 and bendamustine 120mg/m2 by intravenous infusion on day 2 and 3 in the first cycle. From the 2nd to 6th cycle, rituximab will be administered subcutaneously at a fixed dose of 1400mg and bendamustine 120mg/m2 by intravenous infusion on day 1 following administration of rituximab and day 2.

Study groups in NCT02753062
Study groupRoleWhat they receive
bendamustine, rituximabExperimentalBendamustine plus subcutaneous Rituximab treatment of 6 cycles. Rituximab 1400mg subcutaneous over 5mins on day 1 and bendamustine 120mg/m2 + NS 500mL iv over 1hour on day 1 and 2.
Receives: Drug: bendamustine, rituximab

What is being measured

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

  1. complete response rate

    Measured: 6 to 8 weeks after completion of the 6th cycle of treatment.

Secondary outcomes (5)

  1. Assess response rate

    Measured: 2 to 3 weeks (or start of next cycle) after completion of the 3rd cycle of treatment and 6 to 8 weeks after completion of the 6th cycle of treatment.

  2. Assess event-free survival

    Measured: the time from the 1st day of treatment to the first recording of disease-progression, relapse or death of any cause or failure to achieve CR after completion, assessed up to 96 months

  3. Assess overall survival

    Measured: the time from the 1st day of treatment to death of any cause or the date of last follow-up, assessed up to 96 months.

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: From the date of first drug administration until the date of the 28th days of last drug administration, assessed up to 22 weeks

  5. Assess health-related quality of life by EORTC QLQ-C30 (3rd edition)

    Measured: within 14 days prior to treatment start and every 12 months (± 1 months) of follow-up period until final analysis and at the time of disease progression, assessed up to 96 months

Timeline

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

  1. First posted27 Apr 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2018 (estimated)
  4. Study completionAug 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02753062
Sponsor's protocol ID
BR_PTLD
Acronym
PTLD
Status last verified
Apr 2016
First submitted
8 Apr 2016
Last updated
27 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: we will share collected data with principal investigators in Korea

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bendamustine, rituximab in people with Diffuse Large B Cell Lymphoma, run by Asan Medical Center at 1 site in South Korea.

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 11 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 27 Apr 2016. 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 South Korea. 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 Dok Hyun Yoon, M.D., PhD (82-10-3235-3090, dhyoon@amc.seoul.kr), 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: 6 to 8 weeks after completion of the 6th cycle of treatment.). 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 NCT02753062.

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 27 Apr 2016.

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