Trial Outcomes & Findings for Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia (NCT NCT00573378)
NCT ID: NCT00573378
Last Updated: 2023-01-25
Results Overview
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
TERMINATED
PHASE2
12 participants
3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)
2023-01-25
Participant Flow
Participant milestones
| Measure |
PEG-IFN-a2b
PEG-IFN-a2b: Patients receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Evaluable for Primary Outcome Measure
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
PEG-IFN-a2b
n=12 Participants
PEG-IFN-a2b: Patients receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week.
|
|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.
Outcome measures
| Measure |
PEG-IFN-a2b
n=1 Participants
PEG-IFN-a2b: Patients receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week.
|
|---|---|
|
Relapse-free Survival (RFS) Rate 1 Year After Discontinuation of the TKI and IFN
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 years (2 years of treatment with TKI and IFN + 1 year of follow-up)Population: Because there were no molecular remissions at 1 year post treatment discontinuation (measure #1), there was no basis for this analysis. There is no data to summarize.
To determine whether the addition of PEG-IFN-a2b to a TKI (imatinib or nilotinib) improves upon the quality of the molecular remission seen with TKI alone, as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) for the Bcr-Abl transcript.
Outcome measures
Outcome data not reported
Adverse Events
PEG-IFN-a2b
Serious adverse events
| Measure |
PEG-IFN-a2b
n=12 participants at risk
PEG-IFN-a2b: Patients receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week.
|
|---|---|
|
Renal and urinary disorders
Urethral obstruction
|
8.3%
1/12 • Number of events 1 • Throughout study treatment and for 30 days post discontinuation of study treatment (25 months). Patients will continue in follow up; however, AEs will no longer be collected.
Grade 3 and/or 4 serious adverse events (SAE) that are unexpected and definitely, probably or possibly related to protocol therapy are reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Dale L. Bixby, MD
University of Michigan Rogel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place