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Lymphoma, FollicularPhase 2NCT04370405

A Study of YY-20394 in Participants With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma

A Phase 2 study testing YY-20394 in people with Lymphoma, Follicular, run by Shanghai YingLi Pharmaceutical Co. Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study designed to evaluate the efficacy and safety of oral YY-20394 in patients with R/R follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular
What is being tested?
YY-20394
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteChina
Study dates
29 Apr 2019to 22 Feb 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥18 years of age at the time of signing the informed consent.
  • Has histologically or cytologically confirmed follicular non-Hodgkin's lymphoma
  • Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma.(Has been treated with CD20 mAb and at least one alkylating agent, including but not limited to bendamostine, cyclophosphamide, isocyclophosphamide, chlorophenyl butylamine, Malan, busulfan, nitroso
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Has a life expectancy >3 months.
  • Has radiographically measurable disease as per IRWG Criteria with at least one nodal lesion.
Show all 11Show fewer
  • Fine organ function ANC≥1.0×109/L； PLT≥70×109/L(≥50×109/L in patients with bone marrow infiltration )； Hb≥80 g/L(≥70 g/L in patients with bone marrow infiltration)； TBIL≤1.5×ULN； Both ALT and AST≤2.5×ULN； Both BUN/Urea andCr≤1.5×ULN； LVEF≥50%； QTcF(QT interval corrected by friderica)Male<450 ms、Female<470 ms。
  • The washout period lasted at least four weeks of previous anti-tumor treatment (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted treatment) taken by the patient before the study to ensure complete clearance from the body.
  • Has adequate organ function as defined in Table 5 1. Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment:
  • According to the judgment of the researchers, the patients can comply with the trial plan
  • The patient did not participate in the clinical trial as a subject within 1 month before the trial;

Who cannot join

  • 1) Disease progress in the use of PI3kδ inhibitors 2) Pathological transformation of follicular non-Hodgkin's lymphoma to diffuse large B cell lymphoma 3) Any anti-tumor treatment within 4weeks. 4) Pathological fluid accumulations(such as hydrothorax and ascites )can not be controlled by drainage and other method in the third space 5) The dosage of steroid hormone (prednisone equivalent) was more than 20mg / day, and it was used continuously for more than 14 days 6) Has inability to swallow\ chronic diarrhea\ intestine obstruction snd other reasons that could have effluence on the administration and absorbtion. of the drug 7) Can't discontinue use of drugs (such as antiarrhythmic drugs) that may cause QT prolongation during the study.
  • 8) Lymphoma Patients with involvement of central nerve system. 9) Allergic constitution or known allergic history to the components of the drug.
  • 10) Has active effection of viruses\bacterium\ fungi and need to be treated(such as pneumonia ).
  • 11) Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure 12) Has infection of HBV or HCV(Definition: HbsAg and/or HbcAb positive and the copy number of HBV DNA≥1×104/ml or ≥2000 IU/ml ) HCV antibody positive(acute or chornic effected actively) 13) Has history of immunodeficiency disease,include HIV positive or other acquired \ congenital immunodeficiency disease or history of allogeneic bone marrow organ transplangtation or history of hematopoietic stem cell transplangtation 14) Has received hematopoietic stem cell transplangtation within 90 days before the first dose of study treatment.
  • 15) Has any cardiac disease,including:(1)angina;(2) arrhythmias need to be clinical intervented;(3)myocardial infarction;(4)heart failure;(5)any other cardiac diseases that is not suitable for this trail according to the judgement of recheachers.
  • 16) Pregnant and lactating women or fertile women who have a positive pregnancy test 17) Has accompany diseases which do harm to the safety of patients or have impact on the study(such as server hypertension\diabetes\thyroid diseases ) 18) Has other kinds of malignant tumors except skin basal cell carcinoma and cervical carcinoma in situ

Trial locations and contacts

1 site in 1 country.

Hanying Bao, MD,PhD contact

86 21-51370693

hybao@yl-pharm.com

Xiaoming Zhang, PhD contact

86 21-51370693

xmzhang@shangpharma.com

China1 site, 1 recruiting

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 3000

    Lugui Qiu, MD,PhD, 022-23909083, qiulg@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma

This is a study designed to evaluate the efficacy and safety of oral YY-20394 in patients with R/R follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies.

Read the detailed description

The study will be conducted in China to provide safety and efficacy data from this region. A Safety Run-in will be conducted to confirm the safety of the recommended Phase 2 dose (RP2D), 80 mg once daily, in a Asian population. PK samplings at Cycle 1, Day 1 will be taken.

Being tested
YY-20394
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • YY-20394Drug

    YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.

Study groups in NCT04370405
Study groupRoleWhat they receive
YY-20394ExperimentalYY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Receives: Drug: YY-20394

What is being measured

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

  1. Overall response rate, ORR

    Overall response rate (ORRProportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit-) assessed by an Independent Review Committee (IRC).

    Measured: Throughout the study for approximately 2 years

Secondary outcomes (4)

  1. Overall response rate (ORR)

    Overall response rate (ORR-Proportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit) assessed by reseachers.

    Measured: Throughout the study for approximately 2 years

  2. Progression free survival, PFS

    PFS, defined as the time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Throughout the study for approximately 2 years

  3. Overall survival, OS

    The time from randomization to death for any reason.

    Measured: Throughout the study for approximately 2 years

  4. Disease control rate, DCR

    The percentage of cases with remission (PR+CR)and stable lesions(SD) after treatment in the number of evaluable cases.

    Measured: Throughout the study for approximately 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 posted30 Apr 2020
  2. Study start29 Apr 2019
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion22 Feb 2021 (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
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04370405
Sponsor's protocol ID
YY-20394-002
Status last verified
May 2020
First submitted
28 Apr 2020
Last updated
11 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YY-20394 in people with Lymphoma, Follicular, run by Shanghai YingLi Pharmaceutical Co. Ltd. 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 11 inclusion and 6 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 May 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 Hanying Bao, MD,PhD (86 21-51370693, hybao@yl-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate, ORR (time frame: Throughout the study for approximately 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 NCT04370405.

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 May 2020.

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