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NCT00667329 · ClinicalTrials.gov registry record · Phase 1
Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
A Phase 1 study of Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00667329: Completed Phase 1 study of Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT00667329 is a Phase 1 study of Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 14 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667329, a Phase 1 study of Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted. This is an investigational study. The FDA has approved each of these drugs for the treatment of low-grade lymphoma. The combined use of these drugs for Waldenstrom's macroglobulinemia is investigational, although each drug has been effective by itself for this disease. About 50 patients will take part in this study. This study will take place only at UTMDACC (outpatient basis).
Primary Outcome
Response defined as at least 50% reduction of monoclonal IgM synthesis for at least two months with more than 50% reduction of tumor infiltrates at all involved sites (bone marrow, lymph nodes, spleen etc.). Complete response defined as disappearance of abnormal protein by immunofixation, resolution of lymphadenopathy and splenomegaly, less than 20% lymphocytes in bone marrow and no evidence of monoclonal lymphocytes.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG 2CdA
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 1999-07-09 |
| Est. Completion | 2022-02-10 |
| Phase | Phase 1 |
What the finished NCT00667329 record still lists
NCT00667329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00667329 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00667329 about?
NCT00667329 is a clinical study titled "Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab". The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third goal is to see how of...
What is the current status of trial NCT00667329?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 1999-07-09. Estimated completion is 2022-02-10.
What conditions does trial NCT00667329 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT00667329?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), 2CdA (DRUG).
Who is sponsoring clinical trial NCT00667329?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00667329 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 NCT00667329's enrollment target sits among peer trials
14 262nd of 299 higher than 33 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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