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NCT01412879 · ClinicalTrials.gov registry record · Phase 2
S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT01412879: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT01412879 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01412879, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation. PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.
Primary Outcome
Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or \>= 50% increase in greatest transverse diameter (GTD) of any nodal \> 1 cm in shortest axis, or \>= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is \> 1.5 c
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG dexamethasone
- DRUG bendamustine hydrochloride
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2011-11 |
| Est. Completion | 2021-03 |
| Phase | Phase 2 |
What the finished NCT01412879 record still lists
NCT01412879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01412879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01412879 about?
NCT01412879 is a clinical study titled "S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma". RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in differen...
What is the current status of trial NCT01412879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2011-11. Estimated completion is 2021-03.
What interventions are being tested in trial NCT01412879?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), dexamethasone (DRUG), bendamustine hydrochloride (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT01412879?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01412879's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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
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