Back to resultsA Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma (NICE-40)
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Nivolumab
Ifosfamide
Carboplatin
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Nivolumab, Ifosfamide, Carboplatin, Etoposide
Eligibility Criteria
Inclusion Criteria:
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
- Signed informed consent
- No severe concurrent illness
Exclusion Criteria:
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign an informed consent
- Active or prior documented autoimmune disease requiring systemic treatment.
Sites / Locations
- National Medicine Research Center of oncology named after N.N. PetrovRecruiting
- Irkutsk Regional Cancer CenterRecruiting
- St. Petersburg State Pavlov Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main arm
Arm Description
Patients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT. Patients with <CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment.
Outcomes
Primary Outcome Measures
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Overall Response Rate (ORR)
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
Secondary Outcome Measures
Duration of Response (DOR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Full Information
NCT ID
NCT04981899
First Posted
July 19, 2021
Last Updated
April 11, 2023
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04981899
Brief Title
A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Acronym
NICE-40
Official Title
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Nivolumab, Ifosfamide, Carboplatin, Etoposide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main arm
Arm Type
Experimental
Arm Description
Patients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT.
Patients with <CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Primary Outcome Measure Information:
Title
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Description
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Time Frame
12 months
Title
Overall Response Rate (ORR)
Description
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Time Frame
24 months
Title
Overall Survival (OS)
Time Frame
24 months
Title
Progression-Free Survival (PFS)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis: Histologically confirmed Hodgkins lymphoma
Relapsed or refractory disease after the first line of treatment
Age 18-70 years old
Ejection fraction greater than 50%
ECOG 0-2 status
Signed informed consent
No severe concurrent illness
Exclusion Criteria:
Uncontrolled bacterial or fungal infection at the time of enrollment
Requirement for vasopressor support at the time of enrollment
Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
Karnofsky index <30%
Pregnancy
Somatic or psychiatric disorder making the patient unable to sign an informed consent
Active or prior documented autoimmune disease requiring systemic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirill Lepik, MD,PhD
Phone
+78123386265
Email
lepikkv@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Mikhailova, MD,PhD
Email
bmt.lymphoma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Kulagin, MD,PhD
Organizational Affiliation
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Official's Role
Study Director
Facility Information:
Facility Name
National Medicine Research Center of oncology named after N.N. Petrov
City
Saint Petersburg
State/Province
Pesochny
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Shalaev
Phone
+79215590113
Email
Shalaev.haemonc@gmail.com
Facility Name
Irkutsk Regional Cancer Center
City
Irkutsk
ZIP/Postal Code
664044
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Demchenkova
Phone
+79148720236
Email
mdemchenkova@yandex.ru
Facility Name
St. Petersburg State Pavlov Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
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