Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-28 @ 12:56 PM
Study NCT ID:
NCT03272633
Status:
TERMINATED
Last Update Posted:
2023-06-26
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Post-Transplant Use of Irradiated Haplo-Allogeneic Cells
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.
SECONDARY OBJECTIVES:
I. To determine if there is evidence of disease response associated with IHC.
TERTIARY OBJECTIVES:
I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
After completion of study treatment, patients will be followed up within 8 weeks.
I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.
SECONDARY OBJECTIVES:
I. To determine if there is evidence of disease response associated with IHC.
TERTIARY OBJECTIVES:
I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
After completion of study treatment, patients will be followed up within 8 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01537 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| Pro20170000537 | None | None | View | |
| 011702 | OTHER | Rutgers Cancer Institute of New Jersey | View | |
| P30CA072720 | NIH | None | https://reporter.nih.gov/quic… | View |