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Studien: AGMT_CMML 1 |  AGMT_CML 1 | 

 


AGMT_CMML 1

Coordinating Investigator: Prof. Dr. Josef Thaler/ OA Dr. Sonja Burgstaller
Fallzahl: 30
Start: Q1 2010 | Ende: Q1 2015
Status: geschlossen


A Phase I/II Study of Lenalidomide in Patients with Chronic Myelomonocytic Leukemia

Studiendesign

This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. A total of 30 patients is planned to be included. Pretreatment is permitted.

Studienziele

Phase I trial:
Primary objectives:
The primary objective of the phase I trial is to determine the MTD (maximum tolerated dose) of lenalidomide.
Secondary objectives:
Secondary objectives include the evaluation of safety and tolerability.

Phase II trial:
Primary objectives:
The primary objective of the phase II trial is to determine the hematologic response achieved with lenalidomide administered in subjects at the MTD determined in phase I.
Secondary objectives:
The secondary objectives focus on achieving transfusion independence and cytogenetic response. In addition, progression free survival and overall survival will be
determined.

Einschlusskriterien (Auszug)

CMML according to the WHO diagnostic criteria
All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
No prior use of lenalidomide.



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AGMT_CML 1

Coordinating Investigator: Univ.-Prof. Dr. Josef Thaler / OA Dr. Sonja Burgstaller
Fallzahl: 12
Start: 15.07.2013 | Ende: 31.12.2015
Status: recruiting


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)

Studiendesign

This is a phase 1, open label pilot study of adding P1101 to treatment with imatinib in patients with CML in chronic phase. Patients are eligible, if a molecular remission 4.5 or below has not been achieved with imatinib therapy alone after at least 18 months of therapy. Only patients achieving a CHR and a CCyR at study entry will be included. P1101 will be added in a dose of 50µg subcutaneously every 14 days. In the absence of a dose limiting toxicity (DLT), i.e. haematological toxicity ≥ grade 2, non haematological toxicity ≥ grade 3, after 12 weeks of therapy, P1101 will be increased to 100µg subcutaneously every 14 days (refer to 6.2.). In the absence of a DLT after another 12 weeks of therapy, treatment will be continued with the same dose level for further 12 months. A dose of 100µg every 14 days is considered as maximum dose.
Imatinib will be continued at the same dose level as before study entry.


Studienziele

Primary objective:
to determine the safety and tolerability of the addition of P1101 to the currently established dose of imatinib.
Secondary objective:
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.

Einschlusskriterien (Auszug)

• Patients ≥ 18 years of age
• BCR-ABL positive chronic myeloid leukaemia in hronic 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

Öffentliche Downloads

AGMT_CML 1 Poster
Poster am OeGHO 2017



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