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Gray Zone LymphomaPhase 2NCT04860674

A Prospective Study of PD-1 Inhibitor Combined With ICE in the Treatment of Relapsed/Refractory Gray Area Lymphoma

A Phase 2 study testing PD-1 inhibitor +ICE in people with Gray Zone Lymphoma and Relapse/Recurrence, run by Zhejiang Cancer Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

There are no standard chemotherapy regimens for relapse/refractory gray area lymphoma. The programmed cell death ligand 1 (PD-L1) encoding gene is located in 9p24.1, so it is speculated that the programmed cell death pathway plays an important role in gray area lymphoma formation by evading immune surveillance in… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
PD-1 inhibitor +ICE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 May 2021to 1 Apr 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in the clinical study: fully understand and know the study and sign the informed consent form in person;Willing to follow and able to complete all testing procedures.
  • Age: 18~70 years old (inclusive), both male and female.
  • Histopathologically confirmed gray zone lymphoma (between HD and DLBCL).
  • Recurrent or refractory disease after receiving at least first-line standard chemotherapy (refractory is defined as chemotherapy not reaching CR or PR).
  • ECOG score is 0-2 points.
  • Expected survival of at least 3 months.
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  • There must be at least one evaluable or measurable lesion that meets the Lugano2014 criteria.
  • Sufficient organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency
  • Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
  • Serum pregnancy test was negative and effective contraceptive measures were taken from the signing of informed consent until 6 months after the use of the last chemotherapy.
  • Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within the range of ±10% of normal values.
  • There was no evidence that subjects had difficulty breathing at rest and their pulse oximetry at rest was >95%.
  • Subjects must confirm the first forced expiratory volume (FEV1)/forced expiratory volume (FVC) >60% by pulmonary function test, unless large mediastinal mass compression fails to meet this standard;Carbon monoxide dispersion (DLCO), FEV1 and FVC all exceeded the predicted value by more than 50%.
  • Subjects who had received previous anti-tumor therapy were admitted only after the toxicity of previous therapy returned to CTCAE V5.0 level ≤1 or baseline;Class 2 toxicity (such as neurotoxicity, alopecia, and hearing loss) that was irreversible and not expected to worsen during the study period due to prior antitumor therapy were assessed by the investigator and were eligible for inclusion.
  • -

Who cannot join

  • Central nervous system involvement.
  • Participating in other clinical studies, or administering the first study drug less than 4 weeks after the end of treatment in the previous clinical study.
  • Had other malignant tumors in the past 5 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix after radical treatment.
  • The last antitumor treatment was less than 3 weeks after the first administration of the drug in this study, including chemotherapy, immunotherapy, radiotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors for cancer control).
  • Previous allogeneic hematopoietic stem cell transplantation or prior ASCT or CAR-T therapy within 1 month prior to initial dosing of the investigational drug.
  • Have previously received PD-1 or PD-L1 targeted therapy.
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  • A history of severe hypersensitivity to monoclonal antibodies.
  • Major surgery was performed within 28 days prior to the start of study treatment.
  • In this study, the patients received anti-tumor Chinese herbal medicine or proprietary Chinese medicine within 7 days before the first medication.
  • Live vaccine (except attenuated influenza vaccine) was administered within 28 days before the first administration.
  • Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome.
  • Patients with active history of autoimmune disease or blood body autoimmune disease and patients with high risk of recurrence, including but not limited to the immune related neuropathy, multiple sclerosis, autoimmune, demyelinating neuropathy, GBS, myasthenia gravis, systemic lupus erythematosus (sle), scleroderma, connective tissue disease, inflammatory bowel cancer (including crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrosis release or Stevens Johnson syndrome.
  • Corticosteroid (prednisone >10mg/d or equivalent) or other immunosuppressive systemic therapy should be used within 14 days prior to the first administration of the study drug.
  • Patients with active chronic hepatitis B or active hepatitis C.
  • Have active tuberculosis.
  • Present with interstitial pulmonary disease or non-infectious pneumonia.
  • Active infections requiring systematic anti-infective treatment, including but not limited to bacterial, fungal or viral infections.
  • Pregnant or lactating women.
  • Patients with New York Heart Association (NYHA) grade III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmias, and electrocardiographic findings of acute ischemia or myocardial infarction during the preceding 6 months were screened.
  • QTCF interphase >480 Msec, unless secondary to bundle branch block.
  • Have an uncontrollable combined disease, including but not limited to uncontrollable hypertension, active peptic ulcer or hemorrhagic disease.
  • People with previous psychiatric history;Having no capacity or limited capacity.
  • The underlying condition of the patient, as determined by the investigator, may increase the risk of receiving the study drug, or may cause confusion about the perceived toxicity and its assessment.
  • Patients considered by other investigators to be unsuitable for this study. -

Trial locations and contacts

No sites are listed yet.

Cong Li contact

15267115611

licong@zjcc.org.cn

About this study

Official title: A Prospective, Single-arm, Phase II Study of PD-1 Inhibitor Combined With Ifosfamide, Carboplatin, and Etoposide (ICE) in the Treatment of Relapsed/Refractory Gray Area Lymphoma

There are no standard chemotherapy regimens for relapse/refractory gray area lymphoma. The programmed cell death ligand 1 (PD-L1) encoding gene is located in 9p24.1, so it is speculated that the programmed cell death pathway plays an important role in gray area lymphoma formation by evading immune surveillance in GZL.The purpose of this study was to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with ICE in the treatment of patients with relapsed/refractory gray area lymphoma.

Read the detailed description

The purpose of this study was to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with ICE in the treatment of patients with relapsed/refractory gray zone lymphoma. The main study endpoint is the Objective Response Rate (ORR), including Complete Remission Rate (CRR) and Partial Remission Rate (PRR), was evaluated according to Lugano2014 lymphoma efficacy evaluation criteria.

Being tested
PD-1 inhibitor +ICE
Medical subject headings
Recurrence

What participants receive

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

  • PD-1 inhibitor +ICEDrug

    Also called Icyclophosphamide, carboplatin, etoposide

    PD-1 inhibitor (tirelizumab) combined with ifosfamide, carboplatin and etoposide (ICE) regimen

Study groups in NCT04860674
Study groupRoleWhat they receive
PD-1+ICEExperimentalPD-1 inhibitor combined with icyclophosphamide, carboplatin, etoposide chemotherapy
Receives: Drug: PD-1 inhibitor +ICE

What is being measured

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

  1. ORR

    overall response rate

    Measured: From enrollment until date of completion of chemotherapy, at the end of cycle 6 (each cycle is 21 days)

Secondary outcomes (3)

  1. PFS

    Progression Free Survival

    Measured: From date of first day of treatment until the date of first documented progression, assessed up to 24 months

  2. OS

    Overall Survival

    Measured: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months

  3. AE and SAE

    Adverse event and serious adverse event

    Measured: From data of first day of treatment until 30 day after last treatment

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 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2024 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860674
Sponsor's protocol ID
PICE
Status last verified
Apr 2021
First submitted
2 Feb 2021
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD is related to participants' privacy

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhibitor +ICE in people with Gray Zone Lymphoma and Relapse/Recurrence, run by Zhejiang Cancer Hospital.

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 15 inclusion and 24 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 2021. Status can change between updates, so confirm with the study contact before making plans.

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 Cong Li (15267115611, licong@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From enrollment until date of completion of chemotherapy, at the end of cycle 6 (each cycle is 21 days)). 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 NCT04860674.

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 2021.

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