Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00895661 · ClinicalTrials.gov registry record · Phase 2
High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00895661: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00895661 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00895661, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may offer superior efficacy to the current standard dose. This trial also employs intermittent maintenance doses of rituximab at the standard dose, which has been shown to prolong remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly good results to chemotherapy approaches, but without chemotherapy-related toxicity.
Primary Outcome
CR requires all of the following: 1. Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to \<1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). 2. The spleen, if considered to be enlarged before therapy on the basis of a
Interventions
- DRUG rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00895661 record still lists
NCT00895661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which rituximab is the first listed.
NCT00895661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00895661 about?
NCT00895661 is a clinical study titled "High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas". The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the t...
What is the current status of trial NCT00895661?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-07. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00895661?
The interventions under investigation include: rituximab (DRUG).
Who is sponsoring clinical trial NCT00895661?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895661's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia