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NCT00074490 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 442
- Enrollment target
NCT00074490: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00074490 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 442 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (232% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00074490, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 442 participants
- Enrollment target
Study Summary
Background: Patients with cancers of the blood and immune system often benefit from transplants of stem cells from a genetically well-matched sibling. However, severe problems may follow these transplants because of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune cells sometimes attack healthy tissues in a reaction called graft-versus-host disease (GVHD), damaging organs such as the liver, intestines and skin. To reduce toxicity of high-dose preparative chemotherapy, this study performs allogeneic transplant after low doses of chemotherapy. In an attempt to improve anti-tumor effects without increasing GVHD, this study uses donor immune cells (T helper 2 (Th2) cells) grown in the laboratory; some patients will receive standard donor immune cells (not grown in laboratory). All patients will receive immune modulating drugs sirolimus and cyclosporine to prevent GVHD. Objective: To determine the safety, treatment effects and rate of GVHD in patients receiving transplants that use low-intensity chemotherapy, sirolimus plus cyclosporine, and transplant booster with either Th2 cells or standard immune cells. Eligibility: Patients 16 to 75 years of age with acute or chronic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, multiple myeloma, or myelodysplastic syndrome. Patients must have a suitable genetically matched sibling donor and adequate kidney, heart and lung function. Design: The protocol has three treatment groups: cohort 1, Th2 booster at two weeks post-transplant; cohort 2, standard T cell booster at two weeks post-transplant; cohort 3, multiple infusion of Th2 cells. Condition: Hematologic Neoplasms, Myeloproliferative Disorders Intervention: Biological; therapeutic allogeneic lymphocytes Drug: Sirolimus Study Type: Interventional Study Design: Primary Purpose: Treatment Phase: Phase II
Primary Outcome
T cells administered by intravenous infusion after patient received transplant.
Interventions
- DRUG Fludarabine
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Etoposide
- DRUG Vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2004-01-01 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 2 |
Why NCT00074490 stopped before completion
NCT00074490 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (232% higher).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00074490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00074490 about?
NCT00074490 is a clinical study titled "Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers". Background: Patients with cancers of the blood and immune system often benefit from transplants of stem cells from a genetically well-matched sibling. However, severe problems may follow these transplants because of the high-dose chemotherapy and radiation that accompany the procedure. Also, donate...
What is the current status of trial NCT00074490?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 442 participants. The study started on 2004-01-01. Estimated completion is 2017-08-16.
What interventions are being tested in trial NCT00074490?
The interventions under investigation include: Fludarabine (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Etoposide (DRUG), Vincristine (DRUG).
Who is sponsoring clinical trial NCT00074490?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00074490's enrollment target sits among peer trials
442 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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