Completed

High Dose Cyclophosphamide for Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria Treatment

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What is being tested

cyclophosphamide

+ filgrastim

Drug
Who is being recruted

Bone Marrow Failure Disorders+10

+ Anemia

+ Anemia, Hemolytic

Until 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1996
See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: January 18, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1996

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days. Patients are followed every 3 months for at least 2 years and annually thereafter.

NCT00004464
Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: January 18, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow Failure DisordersAnemiaAnemia, HemolyticBone Marrow DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesAnemia, AplasticHematologic DiseasesHemoglobinuria, ParoxysmalRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria Not a candidate for allogeneic bone marrow transplantation Must meet one of the following criteria: Severe aplastic anemia Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3 platelet count less than 20,000/mm3 and granulocytes less than 500/mm3) Life-threatening paroxysmal nocturnal hemoglobinuria Absolute neutrophil count less than 500/mm3 platelet transfusion dependent thrombotic disease No Fanconi anemia No abnormal cytogenetics --Patient Characteristics-- Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 45% Other: Not preterminal or moribund Not pregnant

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins Oncology Center

Baltimore, United StatesOpen Johns Hopkins Oncology Center in Google Maps
CompletedOne Study Center