Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001567
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 uniformly disease progression requiring reinstitution of therapy was observed There appear 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 evaluate the safety and efficacy of long-term recombinant interferon-alpha IFN-Alpha in patients with hairy cell leukemia we opted to administer interferon continuously to patients who were initially responsive to this drug Of the 53 evaluable patients of the 56 entered on this study there was one complete remission 41 partial remissions 1 minor response 9 patients with stable disease and only 1 patient with disease progression Fourteen patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 92 years Thirty-four patients discontinued interferon for a variety of reasons the most common being the development of acquired interferon resistance in association with interferon antibodies The resistance to interferon was manifested early in the first 18 months of treatment except in two cases An important finding in this study is the continued slow but significant hematologic improvement in absolute granulocyte and platelet counts beyond 18 months of therapy thereby indicating that prolonged treatment results in continued benefit rather than the production of antibodies with subsequent development of interferon resistance Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with interferon longer follow-up will be necessary to determine if continuous therapy with interferon is better than intermittent therapy The optimal therapy for hairy cell leukemia remains open to discussion Although early reports suggested that 2-chlorodeoxyadenosine was curative additional studies with longer periods of follow up suggests that as many as 30 of patients will relapse This study provides the only instance where continuous long term treatment with interferon has been evaluated This provides an opportunity to evaluate the long term toxicity of chronic interferon therapy the long term efficacy of this treatment and to evaluate the potential benefits of long term interferon in preventing second malignancies a complication noted in about 15 of patients treated in other fashions
After their initial clinical evaluation patients were given 3 million units of recombinant IFN-Alpha subcutaneously daily for 4 to 6 months In responding patients maintenance therapy was given at a dose of three million units subcutaneously 3 times per week Responding patients have continued on therapy indefinitely
After their initial clinical evaluation patients were given 3 million units of recombinant IFN-Alpha subcutaneously daily for 4 to 6 months In responding patients maintenance therapy was given at a dose of three million units subcutaneously 3 times per week Responding patients have continued on therapy indefinitely
Detailed 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 evaluate the safety and efficacy of long-term recombinant interferon-alpha IFN-Alpha in patients with hairy cell leukemia we opted to administer interferon continuously to patients who were initially responsive to this drug Of the 53 evaluable patients of the 56 entered on this study there was one complete remission 41 partial remissions 1 minor response 9 patients with stable disease and only 1 patient with disease progression Fourteen patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 92 years Thirty-four patients discontinued interferon for a variety of reasons the most common being the development of acquired interferon resistance in association with interferon antibodies The resistance to interferon was manifested early in the first 18 months of treatment except in two cases An important finding in this study is the continued slow but significant hematologic improvement in absolute granulocyte and platelet counts beyond 18 months of therapy thereby indicating that prolonged treatment results in continued benefit rather than the production of antibodies with subsequent development of interferon resistance Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with interferon longer follow-up will be necessary to determine if continuous therapy with interferon is better than intermittent therapy The optimal therapy for hairy cell leukemia remains open to discussion Although early reports suggested that 2-chlorodeoxyadenosine was curative additional studies with longer periods of follow up suggest that as many as 30 of patients will relapse This study provides the only instance where continuous long term treatment with interferon has been evaluated This provides an opportunity to evaluate the long term toxicity of chronic interferon therapy the long term efficacy of this treatment and to evaluate the potential benefits of long term interferon in preventing second malignancies a complication noted in about 15 of patients treated in other fashions
After their initial clinical evaluation patients were given 3 million units of recombinant IFN-Alpha subcutaneously daily for 4 to 6 months In responding patients maintenance therapy was given at a dose of 3 million units subcutaneously 3 times per week Responding patients have continued on therapy indefinitely
After their initial clinical evaluation patients were given 3 million units of recombinant IFN-Alpha subcutaneously daily for 4 to 6 months In responding patients maintenance therapy was given at a dose of 3 million units subcutaneously 3 times per week Responding patients have continued on therapy indefinitely
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-C-0060 | None | None | None |