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NCT01118013 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01118013 is a Phase 2 study that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 6 participants.
The verdict
NCT01118013, a Phase 2 study, was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
Interventions
- BIOLOGICAL filgrastim
- DRUG busulfan
- BIOLOGICAL anti-thymocyte globulin
- BIOLOGICAL therapeutic allogeneic lymphocytes
- BIOLOGICAL donor lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01118013
The ClinicalTrials.gov registry entry for NCT01118013 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which filgrastim is the first listed.
NCT01118013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01118013 about?
NCT01118013 is a clinical study titled "Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant". RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make...
What is the current status of trial NCT01118013?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2010-12. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01118013?
The interventions under investigation include: filgrastim (BIOLOGICAL), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL), donor lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01118013?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
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