Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-04 @ 10:59 AM
Study NCT ID:
NCT02681302
Status:
TERMINATED
Last Update Posted:
2025-07-25
First Post:
2016-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence
Sponsor:
Hackensack Meridian Health
Organization:
Study Overview
Official Title:
Phase Ib-IIA Study of Combined Check Point Inhibition After Autologous Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPIT001
Brief Summary:
The goal of this study is to determine the safety and clinical effect of combined checkpoint inhibition administered after autologous hematopoietic stem cell transplantation in each of six clinical cohorts of high risk and recurrent disease. In addition to assessing the incidence and severity of adverse events and rates of complete response and progression free survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire throughout treatment and at the time of disease progression. Investigators will also analyze the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time of relapse.
Detailed Description:
This is a phase Ib-IIA study of post-transplant combined check point inhibitors for patients with a high risk of relapse (\>50%) after an autologous hematopoietic stem cell transplant.
Patients will accrue to study by disease groups and followed separately by group for incidence and severity of toxicity, ability to receive intended schedule of combined check point inhibitors and for complete response and progression free survival (PFS) rates. Complete response and progression free survival rates will be compared to published standards for each disease group. Expected PFS at 18 months for all post-transplant groups without check point inhibitors is less than 50%. Each group with PFS at 18 months in 4 or more patients (57%) will be considered for eligibility in a successor phase IIB expansion trial.
Patients will accrue to study by disease groups and followed separately by group for incidence and severity of toxicity, ability to receive intended schedule of combined check point inhibitors and for complete response and progression free survival (PFS) rates. Complete response and progression free survival rates will be compared to published standards for each disease group. Expected PFS at 18 months for all post-transplant groups without check point inhibitors is less than 50%. Each group with PFS at 18 months in 4 or more patients (57%) will be considered for eligibility in a successor phase IIB expansion trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: