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NCT00101010 · ClinicalTrials.gov registry record · Phase 2

Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00101010: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00101010 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00101010, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Primary Outcome

Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT \& FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver \& spleen, \& all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic \

Interventions

  • DRUG Cyclophosphamide
  • BIOLOGICAL Rituximab
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL Pegfilgrastim
  • DRUG Pegylated liposomal doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2005-09
Est. Completion 2014-09
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00101010 record still lists

NCT00101010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00101010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00101010 about?

NCT00101010 is a clinical study titled "Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma". RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop...

What is the current status of trial NCT00101010?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2005-09. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00101010?

The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (BIOLOGICAL), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), Pegylated liposomal doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00101010?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00101010's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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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Source: ClinicalTrials.gov NCT00101010, the US trial registry maintained by the National Library of Medicine. NCT00101010 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.