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NCT02342613 · ClinicalTrials.gov registry record · Phase 1
Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation
A Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02342613 is a Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 32 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02342613, a Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 1 clinical study is designed to examine the safety and feasibility of using anti-CD3/CD28 activated marrow infiltrating lymphocytes (MILs) as treatment of relapse after allogeneic hematopoietic cell transplantation (alloHCT) for patients with hematologic malignancies with bone marrow involvement of their relapsed disease. These MILs will be derived from the bone marrow of the relapsed patient who had previously received post-transplantation cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis (PTCy-MILs). A bone marrow aspiration will be performed on the patient to collect \~200ml of marrow for ex vivo expansion. During this expansion process, T cells will be activated and expanded by co-stimulation with anti-CD3/anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic microbeads. Patients will be treated with salvage therapy while this ex vivo expansion is ongoing. After the simultaneous salvage therapy and ex vivo expansion, the activated PTCy-MILs will be reinfused. Patients will be monitored with the primary objective being the feasibility of expanding to targeted dose levels activated PTCy-MILs that do not cause grade III-IV acute GVHD within the first 90 days after PTCy-MIL infusion.
Conditions Studied
Interventions
- BIOLOGICAL Activated PTCy-MILs
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-05-28 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02342613
The ClinicalTrials.gov registry entry for NCT02342613 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (99% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hematologic Malignancies appearing as the primary indexed condition, and to 1 intervention - of which Activated PTCy-MILs is the first listed.
NCT02342613 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02342613 about?
NCT02342613 is a clinical study titled "Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation". This Phase 1 clinical study is designed to examine the safety and feasibility of using anti-CD3/CD28 activated marrow infiltrating lymphocytes (MILs) as treatment of relapse after allogeneic hematopoietic cell transplantation (alloHCT) for patients with hematologic malignancies with bone marrow invo...
What is the current status of trial NCT02342613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-05-28. Estimated completion is 2024-03-31.
What conditions does trial NCT02342613 study?
This clinical trial studies the following conditions: Hematologic Malignancies, Graft-Versus-Host Disease.
What interventions are being tested in trial NCT02342613?
The interventions under investigation include: Activated PTCy-MILs (BIOLOGICAL).
Who is sponsoring clinical trial NCT02342613?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02342613 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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