Chronic Myelogenous Leukemia, Malignant Melanoma, Renal Cell Carcinoma
Conditions
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).
Interventions
DRUGPegylated Interferon Alfa-2a
Participants will maintain the same dose they were receiving in the parent protocol.
DRUGRecombinant Interferon Alfa 2a
Participants will maintain the same dose they were receiving in the parent protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Baseline up to approximately 3 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Tumor Response | Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years) | 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. |
Countries
Bulgaria, Canada, India, Russia, Slovakia, South Africa, Spain
Participant flow
Recruitment details
A total of 9 participants were recruited in the study: 8 participants from study NO16006 (NCT02736721) and 1 participant from study NO16007 (NCT number not available).
Participants by arm
| Arm | Count |
|---|---|
| Interferon Alfa-2A in Cancer Participants Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years). | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Disease remission | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Interferon Alfa-2A in Cancer Participants |
|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 18.3 |
| Gender Female | 2 Participants |
| Gender Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
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.
Time frame: Baseline up to approximately 3 years
Population: All participants who were recruited in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interferon Alfa-2A in Cancer Participants | Number of Participants With Serious Adverse Events (SAEs) | 1 participants |
Secondary
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.
Time frame: Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)
Population: All participants who were recruited in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interferon Alfa-2A in Cancer Participants | Number of Participants With Overall Tumor Response | CR | 9 participants |
| Interferon Alfa-2A in Cancer Participants | Number of Participants With Overall Tumor Response | PR | 0 participants |