Tislelizumab Plus Gemcitabine and Cisplatin for Relapsed or Refractory Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission (TIGERR-HL). An Open Label Phase II Trial

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial investigates the efficacy and safety of the drug tislelizumab in combination with chemotherapy as a treatment for patients with R/R HL. Tislelizumab is given in combination with chemotherapy (gemcitabine and cisplatin) followed by consolidation with tislelizumab alone. The study primary question is whether this strategy works as well as the standard treatment with intensive chemotherapy and autologous stem cell transplant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Histologically confirmed classical HL (according to the latest version of the WHO classification).

• Primary refractory to first line chemotherapy, or in first relapse after any polychemotherapy regimen (e.g. ABVD, baseline BEACOPP or escalated BEACOPP, or other induction regimens).

• In case of relapse, the relapse must be histologically confirmed. In case histologic biopsy is not possible, at least confirmation of the relapse by fine needle aspirate (FNA) or sequential imaging is required.

• Measurable disease, based on Lugano criteria 2014 \[40\]; i.e. CT scans showing at least 2 or more clearly demarcated lesions with a long axis ≥ 1.5 cm and a short axis diameter ≥ 1.0 cm, or 1 clearly demarcated lesion with a long axis ≥ 2.0 cm and a short axis diameter ≥ 1.0 cm. These lesions must be FDG-PET-positive.

• Age 18-70 years inclusive.

• WHO/ECOG Performance Status ≤ 1 (see appendix C).

• No major organ dysfunction, unless HL-related:

‣ Total bilirubin \< 1.5x ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome; in that case bilirubin may be elevated up to 3 x ULN).

⁃ ALT/AST \< 3x ULN (unless due to lymphoma involvement of the liver; in that case ALT/AST may be elevated up to 5 x ULN).

⁃ GFR \> 60 ml/min as estimated by the Cockcroft\&Gault formula.

• Adequate BM function defined as:

‣ Absolute neutrophil count ≥ 1.5x109/L, unless caused by diffuse bone marrow infiltration by the HL.

⁃ Platelets ≥ 75 x109/L, unless caused by diffuse bone marrow infiltration by the HL.

⁃ Hemoglobin must be ≥ 8 g/dL (5 mmol/L).

• Resolution of toxicities from first-line therapy.

• Able to adhere to the study visit schedule and other protocol requirements.

• Negative pregnancy test at study entry.

• Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through at least 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.

• Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.

• Written informed consent.

• Patient is capable of giving informed consent.

Locations
Other Locations
Belgium
BE-Bruxelles-STLUC
RECRUITING
Brussels
Denmark
DK-Aarhus N-AUH
RECRUITING
Aarhus
DK-Copenhagen-RIGSHOSPITALET
RECRUITING
Copenhagen
DK-Odense-OUH
RECRUITING
Odense
Netherlands
NL-Amersfoort-MEANDERMC
RECRUITING
Amersfoort
NL-Amsterdam-AMC
RECRUITING
Amsterdam
NL-Arnhem-RIJNSTATE
RECRUITING
Arnhem
NL-Eindhoven-MAXIMAMC
RECRUITING
Eindhoven
NL-Goes-ADRZ
RECRUITING
Goes
NL-Groningen-UMCG
RECRUITING
Groningen
NL-Hoofddorp-SPAARNEGASTHUIS
RECRUITING
Hoofddorp
NL-Leeuwarden-MCL
RECRUITING
Leeuwarden
NL-Maastricht-MUMC
RECRUITING
Maastricht
NL-Rotterdam-ERASMUSMC
RECRUITING
Rotterdam
NL-Den Haag-HAGA
RECRUITING
The Hague
Contact Information
Primary
S. Tonino
s.h.tonino@amsterdamumc.nl
+31 (0)10 7041560
Backup
W Plattel
w.j.plattel@umcg.nl
+31 (0)10 7041560
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2030-04
Participants
Target number of participants: 75
Treatments
Experimental: Single-arm
4 cycles of gemcitabine and cisplatin (GP) + tislelizumab followed by 13 cycles of tislelizumab
Related Therapeutic Areas
Sponsors
Collaborators: Danish Lymphoma Group
Leads: Stichting Hemato-Oncologie voor Volwassenen Nederland

This content was sourced from clinicaltrials.gov