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NCT00644189 · ClinicalTrials.gov registry record · Phase 1
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT00644189: Completed Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Massachusetts General Hospital.
NCT00644189 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644189, a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell. This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
Primary Outcome
Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG Clofarabine
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-06 |
| Est. Completion | 2021-07 |
| Phase | Phase 1 |
What the finished NCT00644189 record still lists
NCT00644189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (77% lower).
The record links to 10 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Clofarabine is the first listed.
NCT00644189 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00644189 about?
NCT00644189 is a clinical study titled "Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma". Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare t...
What is the current status of trial NCT00644189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2008-06. Estimated completion is 2021-07.
What conditions does trial NCT00644189 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma.
What interventions are being tested in trial NCT00644189?
The interventions under investigation include: Clofarabine (DRUG).
Who is sponsoring clinical trial NCT00644189?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00644189 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell 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 NCT00644189's enrollment target sits among peer trials
50 60th of 114 higher than 53 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell 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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