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NCT00004464 · ClinicalTrials.gov registry record · Phase 2

Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

A Phase 2 study of Aplastic Anemia and Paroxysmal Hemoglobinuria, Nocturnal, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 2
Development phase
69
Enrollment target
1
Study location

NCT00004464 is a Phase 2 study of Aplastic Anemia and Paroxysmal Hemoglobinuria, Nocturnal that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 69 participants, above the 40-participant average among 23 other Aplastic Anemia trials with a reported enrollment target (73% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00004464, a Phase 2 study of Aplastic Anemia and Paroxysmal Hemoglobinuria, Nocturnal, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

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

Study Summary

OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia. II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients. III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.

Interventions

  • DRUG cyclophosphamide
  • DRUG filgrastim

Study Locations (1)

Maryland

  • Johns Hopkins Oncology Center - Baltimore

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 1996-02
Est. Completion 2008-11-11
Phase Phase 2

What the Registry Record Tells You About NCT00004464

The ClinicalTrials.gov registry entry for NCT00004464 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 40-participant average among 23 other Aplastic Anemia trials with a reported enrollment target (73% higher). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Aplastic Anemia appearing as the primary indexed condition, and to 2 interventions - of which cyclophosphamide is the first listed.

NCT00004464 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00004464 about?

NCT00004464 is a clinical study titled "Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria". OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia. II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients. III. Determine whether...

What is the current status of trial NCT00004464?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 1996-02. Estimated completion is 2008-11-11.

What conditions does trial NCT00004464 study?

This clinical trial studies the following conditions: Aplastic Anemia, Paroxysmal Hemoglobinuria, Nocturnal.

What interventions are being tested in trial NCT00004464?

The interventions under investigation include: cyclophosphamide (DRUG), filgrastim (DRUG).

Who is sponsoring clinical trial NCT00004464?

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

Where is trial NCT00004464 being conducted?

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

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