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Compares treatment options for Hodgkin Lymphoma
Official title Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05180097
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- History of classic Hodgkin lymphoma by histopathology and now have relapsed or refractory disease after anthracycline-containing chemotherapy and...
- 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
You likely can't join if
- 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...
- 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...
- Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Concord, New South Wales, Australia
- Nowra, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Adelaide, South Australia, Australia
- Heidelberg, Victoria, Australia
- Perth, Western Australia, Australia
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Regina, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Concord, New South Wales, Australia; Nowra, New South Wales, Australia; Wollongong, New South Wales, Australia; Adelaide, South Australia, Australia; Heidelberg, Victoria, Australia; Perth, Western Australia, Australia and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.