Description:
In this phase I pilot study, it is planned to investigate the feasibility and safety of
adding an interferon therapy to an preexisting imatinib treatment in patients with chronic
phase chronic myeloid leukaemia. The participating patients have already reached a response
during their imatinib therapy (CCyR) but have still a detectable disease (no molecular
response MR 4.5 or better).
Title
- Brief Title: Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
- Official Title: Phase 1 Study to Evaluate the Feasibility and Efficacy of the Addition of P1101 (PEG-Proline-Interferon Alpha-2b) to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response (MR 4.5 or BCR-ABL Transcripts Not Detectable)
Clinical Trial IDs
- ORG STUDY ID:
AGMT_CML 1
- SECONDARY ID:
2013-000115-24
- NCT ID:
NCT01933906
Conditions
- Chronic Phase Chronic Myeloid Leukemia
Interventions
Drug | Synonyms | Arms |
---|
P1101 | PEG-Proline-Interferon alpha-2b | P1101 |
Purpose
In this phase I pilot study, it is planned to investigate the feasibility and safety of
adding an interferon therapy to an preexisting imatinib treatment in patients with chronic
phase chronic myeloid leukaemia. The participating patients have already reached a response
during their imatinib therapy (CCyR) but have still a detectable disease (no molecular
response MR 4.5 or better).
Trial Arms
Name | Type | Description | Interventions |
---|
P1101 | Experimental | P1101 50µg s.c. will be administered every 2 weeks in addition to preexisting imatinib treatment. In the absence of dose limiting toxicities after 12 weeks, the dose will be escalated to 100µg every 2 weeks.
Maximum treatment duration will not expand 18 months. | |
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years of age
- BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as
first line therapy
- CHR, CCyR after at least 18 months of imatinib treatment
- Adequate organ function, defined as the following:
- total bilirubin < 1.5 x ULN,
- AST and ALT < 2.5 x ULN,
- creatinine < 1.5 x ULN,
- ANC > 1.5 x 109/L,
- platelets > 100 x 109/L
- Written, voluntarily signed informed consent
Exclusion Criteria:
- CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
- Patient has received any other investigational treatment within 28 days before study
entry
- Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
- ECOG performance status ≥ 3
- Patients with a primary of a different histological origin than the study indication
(unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell
epithelioma or squamous cell carcinoma of the skin)
- Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated
respiratory, cardiac, hepatic or renal disease etc.)
- Acute chronic infections
- Known autoimmune disease (e.g. collagen disease, polyarthritis, immune
thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune
disorder)
- Female patients who are pregnant or breast-feeding
- Known diagnosis of HIV
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number and seriousness of adverse events to evaluate safety and tolerability |
Time Frame: | 30 months |
Safety Issue: | |
Description: | The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib. |
Secondary Outcome Measures
Measure: | Efficacy (Number of patients achieving an improvement of remission status) |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Secondary objective is to determine the rate of achievement of ≥ 1 log reduction from the initial BCR-ABL transcript level at study entry and the achievement of molecular remission 4.5 or undetectable BCR-ABL transcripts. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Arbeitsgemeinschaft medikamentoese Tumortherapie |
Trial Keywords
- CML
- Chronic myeloid leukemia
- Chronic myeloid leukaemia
- PEG-Proline-Interferon-alpha 2b
- Interferon
- P1101
- Imatinib
Last Updated
January 4, 2019