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Classical Hodgkin LymphomaPhase 2NCT04624984

PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL

A Phase 2 study testing PD-1 inhibitor and PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome in people with Classical Hodgkin Lymphoma and Refractory or Relapsed Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 3 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PD-1 inhibitor and PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesChina
Study dates
1 Apr 2021to Apr 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed classical Hodgkin lymphoma;
  • Refractory to or relapsed after first-line induction therapy; prior radiotherapy is allowed;
  • At least one evaluable lesion according to 2014 Lugano criteria;
  • Life expectancy > 3 months;
  • Eastern Cooperative Oncology Group (ECOG) of 0-1;
  • Able to participate in all required study procedures;
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  • Proper functioning of the major organs: 1) The absolute value of neutrophils (>1.5×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 80 g/L); 4) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) < 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time). ; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (±10%);
  • There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%;
  • Volunteers who signed informed consent.

Who cannot join

  • Involvement of central nervous system (CNS);
  • Previously received treatment of immune checkpoint inhibitors (eg. PD-1, PD-L1, CTLA-4);
  • Previously received treatment of hematopoietic cell transplantation;
  • Patients with Hemophagocytic syndrome;
  • Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
  • Requiring treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens).
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  • Uncontrolled active infection, with the exception of tumor-related B symptom fever;
  • History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
  • Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 10^4 copies/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 10^4 copies/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
  • Diagnosed with or receiving treatment for malignancy other than lymphoma;
  • Pregnant or breastfeeding women;
  • Other researchers consider it unsuitable for patients to participate in this study.

Trial locations and contacts

3 sites in 1 country.

Qingqing Cai, MD contact

0086-20-87342823

caiqq@sysucc.org.cn

China3 sites, 3 recruiting

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

    Guangzhou, Guangdong, 51000

    Yudan Wu, MD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Qingqing Cai, MD

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510060

    Xueyi Pan, MD

    Recruiting

Other trials in China

About this study

Official title: PD-1 Inhibitor or PD-1 Inhibitor Plus GVD(Gemcitabine, Vinorelbine and Doxorubicin Liposome) Regimen for Relapsed/Refractory Classical Hodgkin Lymphoma (R/R CHL): a Single Arm, Open Label, Phase II Study

This phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy.

Being tested
PD-1 inhibitor, PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome

What participants receive

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

  • PD-1 inhibitorDrug

    PD-1 Inhibitor, intravenous drip, d1.

  • PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposomeDrug

    PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1;

Study groups in NCT04624984
Study groupRoleWhat they receive
PD-1 Inhibitor or PD-1 Inhibitor with GVDExperimentalAll patients receive PD-1 Inhibitor on day 1. Treatment cycles repeat every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR or PR receive PD-1 Inhibitor for another 3 cycles. Patients with PD or SD receive PD-1 Inhibitor plus GVD (gemcitabine, vinorelbine and doxorubicin liposome) regimen every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR after 6 cycles of PD-1 Inhibitor treatment can receive radiotherapy or ASCT, which is determined by investigators. Patients with PR receive 2-4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with PD or SD receive 4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with confirmed CR or PR after PD-1 Inhibitor plus GVD regimen can receive radiotherapy or ASCT, which is determined by investigators. Patients with PD or SD quit the trial.
Receives: Drug: PD-1 inhibitor; Drug: PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome

What is being measured

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

  1. Complete remission rate

    Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

    Measured: 2 years

Secondary outcomes (6)

  1. Objective Response rate

    Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

    Measured: 2 years

  2. Progression Free Survival

    The time from the start of treatment to the progression of the tumor or death (due to any cause).

    Measured: 5 years

  3. Overall Survival

    The time from the start of treatment to time of death (due to any cause).

    Measured: 5 years

  4. Duration of Response

    The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).

    Measured: 5 years

  5. Time to Response (TTR)

    The time from the start of treatment to the first assessment of complete remission or partial remission.

    Measured: 2 years

  6. Percentage of Participants With Adverse Events

    Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0

    Measured: 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 posted12 Nov 2020
  2. Study start1 Apr 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624984
Sponsor's protocol ID
B2020-238-01
Status last verified
May 2022
First submitted
6 Nov 2020
Last updated
9 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhibitor and PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome in people with Classical Hodgkin Lymphoma and Refractory or Relapsed Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 3 sites 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 9 inclusion and 12 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Qingqing Cai, MD (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate (time frame: 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 NCT04624984.

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 9 May 2022.

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