Back to resultsA Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies
Primary Purpose
Chronic Myelogenous Leukemia, Malignant Melanoma, Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pegylated Interferon Alfa-2a
Recombinant Interferon Alfa 2a
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria:
- Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
- CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study
Exclusion Criteria:
- Pregnant or lactating women
- Refusal to use adequate contraceptive measures among men and women of childbearing potential
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interferon Alfa-2A in Cancer Participants
Arm Description
Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years).
Outcomes
Primary Outcome Measures
Number of Participants With Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.
Secondary Outcome Measures
Number of Participants With Overall Tumor Response
Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02829775
Brief Title
A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies
Official Title
Extension Protocol for Patients With Chronic Myelogenous Leukemia, Malignant Melanoma or Renal Cell Carcinoma That Have Responded to Treatment With Pegylated-Interferon α-2a or Roferon-A® in Prior Clinical Studies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, Malignant Melanoma, Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interferon Alfa-2A in Cancer Participants
Arm Type
Experimental
Arm Description
Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years).
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Participants will maintain the same dose they were receiving in the parent protocol.
Intervention Type
Drug
Intervention Name(s)
Recombinant Interferon Alfa 2a
Other Intervention Name(s)
Roferon-A
Intervention Description
Participants will maintain the same dose they were receiving in the parent protocol.
Primary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.
Time Frame
Baseline up to approximately 3 years
Secondary Outcome Measure Information:
Title
Number of Participants With Overall Tumor Response
Description
Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.
Time Frame
Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study
Exclusion Criteria:
Pregnant or lactating women
Refusal to use adequate contraceptive measures among men and women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Sofia
ZIP/Postal Code
1757
Country
Bulgaria
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
Lucknow
ZIP/Postal Code
226 014
Country
India
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Kosice
ZIP/Postal Code
040 66
Country
Slovakia
City
Durban
ZIP/Postal Code
4091
Country
South Africa
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies
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