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NCT01875237 · ClinicalTrials.gov registry record · Phase 1
Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01875237: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01875237 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875237, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if giving genetically changed immune cells, called T-cells, after chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene transfer." Researchers want to learn if these genetically-changed T-cells are effective in attacking cancer cells in patients with leukemia, MDS, lymphoma, Hodgkin disease, or MM, after they have received an allogeneic stem cell transplant. The chemotherapy you will be given on study is fludarabine, melphalan, and alemtuzumab. These drugs are designed to stop the growth of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block your body's ability to reject the donor's stem cells. Researchers also want to learn if giving AP1903 will help the symptoms of graft-versus-host disease (GvHD) that may occur after the T-cell infusion. GvHD occurs when donor cells attack the cells of the person receiving the stem cell transplant.
Primary Outcome
To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events.
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Alemtuzumab
- DRUG Tacrolimus
- PROCEDURE Stem Cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-12-27 |
| Est. Completion | 2017-03-07 |
| Phase | Phase 1 |
Why NCT01875237 stopped before completion
NCT01875237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01875237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01875237 about?
NCT01875237 is a clinical study titled "Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene". The goal of this clinical research study is to learn if giving genetically changed immune cells, called T-cells, after chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied. The process of changing the DNA (the genetic material in cells)...
What is the current status of trial NCT01875237?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-12-27. Estimated completion is 2017-03-07.
What interventions are being tested in trial NCT01875237?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Alemtuzumab (DRUG), Tacrolimus (DRUG), Stem Cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01875237?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01875237's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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