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NCT00134082 · ClinicalTrials.gov registry record · Phase 1

Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma

A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT00134082: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT00134082 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00134082, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
31 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, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.

Primary Outcome

Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.

Interventions

  • DRUG Cyclophosphamide
  • BIOLOGICAL Rituximab
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL KGEL vaccine

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2005-11
Est. Completion 2013-01
Phase Phase 1

What the finished NCT00134082 record still lists

NCT00134082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT00134082 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00134082 about?

NCT00134082 is a clinical study titled "Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin 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, such as cyclophosphamide, wor...

What is the current status of trial NCT00134082?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2005-11. Estimated completion is 2013-01.

What interventions are being tested in trial NCT00134082?

The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (BIOLOGICAL), Filgrastim (BIOLOGICAL), KGEL vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00134082?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00134082's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00134082, the US trial registry maintained by the National Library of Medicine. NCT00134082 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.