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AzTrials

Hodgkin LymphomaPhase 2NCT04843267

A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT

A Phase 2 study testing Tislelizumab in people with Hodgkin Lymphoma and Chemotherapy Effect, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The experimental drug regimen in this study includes a PD-1 antibody (tislelizumab) single-drug induction treatment period and a PD-1 antibody + AVD combined treatment period. 1. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hodgkin Lymphoma, Chemotherapy Effect
What is being tested?
Tislelizumab
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2021to 1 May 2025
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

  • Patients with newly diagnosed classical Hodgkin lymphoma (HL) confirmed by histopathology;
  • Stage III-IV, or Stage IIB patients with at least one high-risk factor (NCCN standard)
  • Patients not suitable for receiving radiotherapy subsequently
  • Patients with at least one assessable lesion (according to Lugano 2014 standard);
  • Age 18 or above (including 18), no gender requirement;
  • ECOG PS score of 0-1 points;
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  • Expected survival time ≥ 3 months;
  • Hematopoietic function: absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/L; liver function: for patients with non-hepatitis B, total bilirubin, ALT and AST <1.5×ULN (upper limit of normal); patients with hepatitis B need to take effective antiviral drugs, and HBV-DNA copy <2000 IU/ml and ALT<2×ULN; renal function: creatinine <1.5×ULN and creatinine clearance rate ≥50ml/min;
  • With normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy;
  • Not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment;
  • Voluntarily signing an informed consent form before trial screening.

Who cannot join

  • Nodular lymphocyte predominant HL;
  • Patients received any form of anti-tumor therapy in the past;
  • Patients planning to receive radiotherapy or autologous stem cell transplantation;
  • With involvement of central nervous system (meninges or brain parenchyma);
  • Pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures;
  • Patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation;
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  • Patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment;
  • Patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment,
  • Patients with known active interstitial pneumonia;
  • Abnormal liver function (total bilirubin>1.5×ULN, ALT/AST>2.5×ULN or ALT/AST>5×ULN for patients with liver invasion), abnormal renal function (serum creatinine>1.5×ULN), abnormal electrolyte metabolism;
  • Peripheral neuropathy ≥ Grade 2;
  • Patients with a history of prolonged QT interval which is of clinical significance (male> 450ms, female> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug therapy;
  • Patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac B-ultrasonography;
  • Mentally disturbed/patients unable to give informed consent;
  • Patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse;
  • Participating in another interventional clinical study at the same time; Patients not suitable to participate in this trial by the judgment of investigators.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Zhiming Li, +86-020-87343765, lizhm@sysucc.org.cn

    Recruiting

Other trials in China

About this study

The experimental drug regimen in this study includes a PD-1 antibody (tislelizumab) single-drug induction treatment period and a PD-1 antibody + AVD combined treatment period.

  1. PD-1 antibody (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for CR patients): PD-1 antibody (tislelizumab), specification: 100mg/bottle. Usage and dosage: intravenous drip, 200mg each time, QD, D1. In the above PD-1 antibody single-drug regimen, 21 days are regarded as a treatment cycle, and all patients first receive 2 courses of PD-1 antibody single-drug induction treatment;
  2. PET/CT mid-term efficacy evaluation used for guiding follow-up treatment options: PET/CT efficacy evaluation before the 3rd course of treatment (PET/CT2): CR patients: continue to receive PD-1 antibody monotherapy, and then receive 4 courses of PD-1 antibody therapy; PR patients: sequential 4 courses of PD-1 antibody + AVD combined chemotherapy; PD+SD patients: out group, and receive other anti-lymphoma therapy deemed suitable by the investigators; After the 6th course, patients not out of the group receive PET/CT3 efficacy evaluation: CR patients: end the treatment and enter the follow-up; PR patients: receive 2 more courses of PD-1 antibody + AVD combined chemotherapy, and then enter the follow-up.
  3. PD-1 antibody + AVD combined treatment period (3rd-6th/8th course for PR patients):

PD-1 antibody, specification: 100mg/bottle. Usage and dosage: intravenous drip, 100mg each time, QD, d1, d15. AVD regimen Doxorubicin 25mg/m2, d1, d15 intravenous injection Vindesine 3mg/m2, d1, d15 intravenous injection Dacarbazine 0.375mg/m2, d1, d15 intravenous drip In this combined treatment regimen, every 28 days is a treatment cycle, and the PD-1 antibody is used in combination with AVD in D1 and D15 of each treatment cycle.

Being tested
Tislelizumab
Medical subject headings
Hodgkin Disease

What participants receive

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

  • TislelizumabDrug

    Tislelizumab in first-line treatment of Hodgkin's lymphoma

What is being measured

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

  1. complete response rate after two cycles of tislelizumab

    complete response rate after two cycles of tislelizumab by PET/CT

    Measured: 6 weeks

Timeline

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

  1. First posted13 Apr 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 May 2025 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843267
Sponsor's protocol ID
B2020-324-01
Status last verified
Apr 2021
First submitted
12 Apr 2021
Last updated
13 Apr 2021
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 Tislelizumab in people with Hodgkin Lymphoma and Chemotherapy Effect, run by Sun Yat-sen University 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 16 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 13 Apr 2021. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate after two cycles of tislelizumab (time frame: 6 weeks). 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 NCT04843267.

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 13 Apr 2021.

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