Search / Trial NCT00001567

A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Follow Up Study Relapse Free Survival Serum Soluble Il 2 Receptor Hematologic Malignancy Chronic Therapy

Description

This study began as an efficacy study of interferon alpha-2a in patients with hairy cell leukemia. It was observed that most patients responded with interferon, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once interferon was stopped, nearly uniform disease progression requiring reinstitution of therapy was observed. There appears to be very few if any patients who will not require further therapy after receiving 12 or 18 months of continuous interferon treatment. Because of these findings, and in order to ...

Gender

All

Eligibility criteria

  • Age 18-70.
  • Patients must have morphologically identifiable hairy cells in peripheral blood and bone marrow, or tissue biopsies with at least one of the following: 1) Positive stain for the tartrate-resistant acid phosphatase 2) Electron microscopy compatible with hairy cells.
  • Patients must be ambulatory with an expected survival greater than 16 weeks and be willing and able to give written informed consent.
  • Patients must have a disease that is assessable, defined by: 1) Pancytopenia 2) Bone marrow leukemic infiltrate 3) Lymphadenopathy, splenomegaly, or hepatomegaly.
  • Patients must not require palliative chemotherapy, immunotherapy or hormonal therapy other than the treatment prescribed in this protocol.
  • Patients must be tested for Hepatitis B surface antigen within one week of entry into this study.
  • No pregnant or lactating women. No fertile men and women, unless using effective contraception.
  • No patients with unstable angina. Patients with Class III or IV cardiovascular disease may be entered only after medical clearance by a cardiology consultant.
  • No patients with severe intercurrent infection or patients having had surgery within the past four weeks unless fully recovered.
  • No patients with impaired renal function (serum creatinine greater than 1.8).
  • No patients with impaired hepatic function (total bilirubin greater than 1.4).
  • No patients with serum calcium greater than 12 mg/dl.
  • No patients with a performance status less than or equal to 60% on the Karnofsky scale.
  • No patients who have had any prior (leukocyte or fibroblast) interferon therapy.
  • No patients unable to carry out the treatment program.
  • No patients less than 20,000 per cu mm platelets and clinical bleeding disorder; both must be present for patient to be excluded.

Attachments

readout_NCT00001567_2024-06-14.pdf

4.5 MB

NCT00001567_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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