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NCT01473628 · ClinicalTrials.gov registry record · Phase 1
Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma
A Phase 1 study of Ann Arbor Stage I Grade 1 Follicular Lymphoma and Ann Arbor Stage I Grade 2 Follicular Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT01473628: Active Phase 1 study of Ann Arbor Stage I Grade 1 Follicular Lymphoma and Ann Arbor Stage I Grade 2 Follicular Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT01473628 is a Phase 1 study of Ann Arbor Stage I Grade 1 Follicular Lymphoma and Ann Arbor Stage I Grade 2 Follicular Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473628, a Phase 1 study of Ann Arbor Stage I Grade 1 Follicular Lymphoma and Ann Arbor Stage I Grade 2 Follicular Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with rituximab may kill more cancer cells.
Primary Outcome
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between two different patient groups. The chi-square test or the Fisher's exact test will then be applied to assess the association between two categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate. Kaplan-Meier survival curves will also be constructed.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Rituximab
- OTHER Clinical Observation
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-05-20 |
| Est. Completion | 2027-05-20 |
| Phase | Phase 1 |
What the registry record for NCT01473628 still lists
NCT01473628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 4 conditions, with Ann Arbor Stage I Grade 1 Follicular Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT01473628 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01473628 about?
NCT01473628 is a clinical study titled "Radiation Therapy and Rituximab in Treating Patients With Stage I-II Grade 1 or Grade 2 Follicular Lymphoma". This randomized phase I/II trial studies radiation therapy and rituximab in treating patients with stage I-II grade 1 or grade 2 follicular lymphoma. Radiation therapy uses high energy x-rays to kill cancer cells. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immun...
What is the current status of trial NCT01473628?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2013-05-20. Estimated completion is 2027-05-20.
What conditions does trial NCT01473628 study?
This clinical trial studies the following conditions: Ann Arbor Stage I Grade 1 Follicular Lymphoma, Ann Arbor Stage I Grade 2 Follicular Lymphoma, Ann Arbor Stage II Grade 1 Follicular Lymphoma, Ann Arbor Stage II Grade 2 Follicular Lymphoma.
What interventions are being tested in trial NCT01473628?
The interventions under investigation include: Radiation Therapy (RADIATION), Rituximab (BIOLOGICAL), Clinical Observation (OTHER).
Who is sponsoring clinical trial NCT01473628?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01473628 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01473628's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
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