Save

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma

PHASE2RECRUITING

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.

Simpliy with AI

Study details:

Treatment given to participants whose disease has not responded to (refractory) or returned (relapsed) after previous treatment is known as salvage treatment. The standard of care for participants who are not in a study is salvage treatment with gemcitabine, dexamethasone and cisplatin (GDP). This treatment can reduce symptoms and may stop the lymphoma from growing for a few months or longer.

This standard treatment is approved by Health Canada. We are doing this study because we want to find out if treatment with Pembrolizumab and Brentuximab vedotin is better or worse than the standard of care for this type of cancer, classical Hodgkin lymphoma. The standard of care is defined as care most people get for your cancer.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

History of classic Hodgkin lymphoma by histopathology and now have relapsed or refractory disease after anthracycline-containing chemotherapy and eligible for high dose chemotherapy and autologous stem cell transplant

18 years of age or greater

ECOG performance status 0-1

Clinically and/or radiologically measurable disease as per the Lugano 2014 classification

Life expectancy > 90 days

Absolute neutrophils ≥1.0 x 10^9/L; Platelets ≥75 x 10^9/L; Hemoglobin ≥80 g/L: Bilirubin ≤1.50 x UNL; AST and ALT ≤2.50 x UNL; Serum creatinine <1.55 x UNL or Creatinine clearance ≥30 mL/min

Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires and/or health utility in either English or French

Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.

Participants must be accessible for treatment and follow-up.

In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment

Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during the study plus approximately 6 months after treatment completion

All patients must have a tumour block from their primary diagnostic biopsy and relapse/refractory biopsy if available and the centre/pathologist must have agreed to release the block or recently cut slides for correlative analysis if the participant has consented. If the primary diagnostic biopsy is not accessible, the original pathology report should be submitted for review and a biopsy from the relapse/refractory disease must be submitted.

Exclusion criteria

Participants who have received prior salvage systemic therapy for their relapsed or refractory disease.

History of peripheral neuropathy or dyspnea ≥ grade 2

Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast, or localized excised prostate cancer, other solid tumours curatively treated with no evidence of disease for > 3 years

History of active CNS disease

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first and any dose of trial treatment

Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Known history of human immunodeficiency virus (HIV), active Hepatitis C Virus infection, active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Participants that are Hepatitis B core antibody positive are eligible if they are HBV DNA negative and are concurrently treated with anti-viral therapy. Participants with a past history of hepatitis C who have eradicated the virus are eligible

Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, angina, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification

Documented history of cerebral vascular event (stroke or transient ischemic attack)

History of progressive multifocal leukoencephalopathy (PML).

Any serious active disease or co-morbid medical condition, including psychiatric illness, judged by the local investigator to preclude safe administration of the planned protocol treatment or required follow-up

Any other serious intercurrent illness, life-threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): active, uncontrolled bacterial, fungal or viral infection; clinically significant cardiac dysfunction or cardiovascular disease

Participants who have been vaccinated with live, attenuated vaccines within 4 weeks of enrollment

Pregnant or lactating females, or women/men of childbearing potential not willing to use an adequate method of birth control for the duration of the study through 6 months after the last dose of trial treatment

Participants are not eligible if they have had a prior infusion reaction to the study drugs or their components > grade 2

Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Participant has had an allogenic tissue/solid organ transplant

Concurrent or within the previous 4 weeks of randomization, treatment with other investigational drugs or anti-cancer therapy

Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A one-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy)

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-11-01

Primary completion: 2025-06-30

Study completion finish: 2026-06-30

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05180097

Intervention or treatment

DRUG: Gemcitabine

DRUG: Dexamethasone

DRUG: Cisplatin

DRUG: Brentuximab vedotin

DRUG: Pembrolizumab

Conditions

• Hodgkin Lymphoma

Condition: Hodgkin Lymphoma
DRUG: Gemcitabine and other drugs
Heidelberg, Victoria, Australia
Sponsor: Canadian Cancer Trials Group

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Hospital

Research sites nearby

Select from list below to view details:

Austin Hospital
Heidelberg, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: GDP Not Specified	DRUG: Gemcitabine 1000mg/m2 IV, 30 mins D1, D8
ACTIVE_COMPARATOR: Brentuximab vedotin + Pembrolizumab Not Specified	DRUG: Brentuximab vedotin 1.8 mg/kg IV, 30 mins, Q21 days

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy	Not Specified	52 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Progression-free survival	Not Specified	52 months
Event-free survival	Not Specified	52 months
Overall survival	Not Specified	52 months
Successful stem cell collection rate	Not Specified	52 months
Transplantation rate	Not Specified	52 months
Number and severity of adverse events	Not Specified	52 months
Participant-reported Quality of Life utilizing EORTC QLQ-C30	Not Specified	52 months
Participant-reported toxicity utilizing PRO-CTCAE	Not Specified	52 months
Participant-reported Quality of Life utilizing FACT-LYM evaluating symptoms and concerns associated specifically with the lymphoma disease and/or disease treatment.	Not Specified	52 months
Participant-reported Quality of Life utilizing FACT/GOG-Ntx-Subscale specifically with chemotherapy-induced neuropathy	Not Specified	52 months
Health Economics utilizing EQ-5D-5L	Not Specified	52 months
Health Economics financial toxicity utilizing FACIT-COST	Not Specified	52 months

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma