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Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01027000 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Giving low doses of chemotherapy before a donor 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. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
- DRUG methotrexate
- DRUG busulfan
Study Locations (20)
New York
- Roswell Park Cancer Institute — Buffalo
- Monter Cancer Center of the North Shore-LIJ Health System — Lake Success
- CCOP - North Shore University Hospital — Manhasset
- Don Monti Comprehensive Cancer Center at North Shore University Hospital — Manhasset
- Long Island Jewish Medical Center — New Hyde Park
- New York Weill Cornell Cancer Center at Cornell University — New York
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber/Brigham and Women's Cancer Center — Boston
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute — Boston
Delaware
- Tunnell Cancer Center at Beebe Medical Center — Lewes
- CCOP - Christiana Care Health Services — Newark
Florida
- Florida Hospital Cancer Institute at Florida Hospital Orlando — Orlando
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa
California
- City of Hope Comprehensive Cancer Center — Duarte
Illinois
- University of Chicago Cancer Research Center — Chicago
Iowa
- Holden Comprehensive Cancer Center at University of Iowa — Iowa City
Maryland
- Union Hospital of Cecil County — Elkton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-02 |
| Est. Completion | 2023-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01027000
The ClinicalTrials.gov registry entry for NCT01027000 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 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 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01027000 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Massachusetts, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01027000 about?
NCT01027000 is a clinical study titled "Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". RATIONALE: Giving low doses of chemotherapy before a donor 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. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or del...
What is the current status of trial NCT01027000?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2010-02. Estimated completion is 2023-04.
What conditions does trial NCT01027000 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01027000?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), methotrexate (DRUG), busulfan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01027000?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01027000 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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