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NCT00878254 · ClinicalTrials.gov registry record · Phase 2

Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

A Phase 2 study of Mantle Cell Lymphoma, sponsored by University of Miami.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target
1
Study location

NCT00878254: Completed Phase 2 study of Mantle Cell Lymphoma, sponsored by University of Miami.

NCT00878254 is a Phase 2 study of Mantle Cell Lymphoma that has completed, run by University of Miami. The registered enrollment target is 25 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00878254, a Phase 2 study of Mantle Cell Lymphoma, has completed, sponsored by University of Miami.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).

Primary Outcome

Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans.

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG Rituximab
  • DRUG Cytarabine
  • BIOLOGICAL G-CSF

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-03-25
Est. Completion 2025-05-30
Phase Phase 2
University of Miami

721 total trials

What the finished NCT00878254 record still lists

NCT00878254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00878254 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00878254 about?

NCT00878254 is a clinical study titled "Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma". The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).

What is the current status of trial NCT00878254?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2009-03-25. Estimated completion is 2025-05-30.

What conditions does trial NCT00878254 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma.

What interventions are being tested in trial NCT00878254?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Cytarabine (DRUG), G-CSF (BIOLOGICAL).

Who is sponsoring clinical trial NCT00878254?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00878254 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Mantle 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 NCT00878254's enrollment target sits among peer trials

25 77th of 102 higher than 26 of 102 other Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mantle 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00878254, the US trial registry maintained by the National Library of Medicine. NCT00878254 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.