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NCT01027000 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Lymphoma and Leukemia, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT01027000: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by Alliance for Clinical Trials in Oncology.
NCT01027000 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 68 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027000, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. A progression is defined as one of the following events: * \>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be \>= 2 cm); appearance of new palpable lymph nodes. * \>= 50% incr
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 |
What the finished NCT01027000 record still lists
NCT01027000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (86% lower).
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.
NCT01027000 names 20 study sites across 11 states, led by New York, Massachusetts, Delaware.
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.
What interventions are being tested in trial NCT01027000?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), methotrexate (DRUG), busulfan (DRUG).
Who is sponsoring clinical trial NCT01027000?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01027000's enrollment target sits among peer trials
68 119th of 299 higher than 180 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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