NCT04044222

Brief Summary

This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

August 1, 2019

Last Update Submit

September 12, 2022

Conditions

Classic Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • PFS

    44months

Study Arms (2)

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)

EXPERIMENTAL

Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.

Biological: SintilimabDrug: CarboplatinDrug: EtoposideDrug: Ifosfamide

Treatment (placebo, etoposide, ifosfamide, carboplatin)

EXPERIMENTAL

Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.

Drug: PlaceboDrug: CarboplatinDrug: EtoposideDrug: Ifosfamide

Interventions

SintilimabBIOLOGICAL

IV

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
CarboplatinDRUG

IV

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
EtoposideDRUG

IV

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
IfosfamideDRUG

IV

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
PlaceboDRUG

IV

Treatment (placebo, etoposide, ifosfamide, carboplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Histopathologically confirmed cHL
  • Failed first-line standard combination chemotherapy
  • One measurable lesion (Lugano 2014)
  • Eastern Cooperative Oncology Group (ECOG) of 0-1
  • Male or female aged ≥18 years
  • Patients must have adequate organ and bone marrow function

You may not qualify if:

  • Patients must not have known central nervous system (CNS) involvement
  • Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
  • Patients may not simultaneously participate in another interventional clinical study
  • Patients may not receive any other investigational agents within 4 weeks of study registration
  • Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
  • Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period)
  • Patients with known immunodeficiency are ineligible
  • Patients with known active TB (Bacillus tuberculosis) are ineligible
  • Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
  • Patients must not be pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

sintilimabCarboplatinEtoposideIfosfamide

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ronghua Zhang

CONTACT

15267110561ronghua.zhang@innoventbio.com

Hui Zhou

CONTACT

86-021-31837200hui.zhou@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

October 21, 2019

Primary Completion

July 30, 2023

Study Completion

December 31, 2024

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

CN(1)