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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 148 AML


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

A phase Ib feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AML


Status

open


Members

HOVON



Study details



Type of study

Prospective Phase I/II study


Echelon level

Level A


Type of monitoring for this study

Site evaluation visits


Target number of patients

30


Date of first EC&CA submission

22-Dec-2017


Date of activation

16-Jul-2018


Approved by

NL:CCMO 17-01-2018
NL: METC EUR 14-05-2018


Study objectives

Primary objective:
To asses the safety and feasibility of post-transplant panobinostat combined with midostaurin in patients with adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in terms of dose limiting toxicity.

Secondary objectives:
To assess feasibility in terms of completion of the protocol treatment
♦ To assess efficacy in terms of:
Complete hematological remission (with full peripheral blood recovery) rate at 3, 6 and 12 months post alloHSCT.
Immunological remission (residual disease assessed by multicolor flowcytometry) at 6 months post alloHSCT
Relapse/progression rate as assessed after cycle 1, 3, 5 and 7 and at 12 months post alloHSCT, or at approx. 3, 6 and 12 months post alloHSCT in case of early termination of protocol treatment.
Overall survival (OS) from alloHSCT
Progression free survival (PFS) from alloHSCT with relapse (for patients in CR) and progression (for patients in PR) and death from any cause as events
Engraftment and chimerism at 3, 6 and 12 months post alloHSCT

♦ To assess toxicity in terms of:
The incidence and nature of (serious) adverse events
The incidence and severity of acute and chronic GvHD up to 12 months post alloHSCT
NRM up to 12 months post alloHSCT
Number and percentage of registered patients starting protocol treatment
Number and percentage of patients receiving post-transplant epigenetic therapy after alloHSCT


2. Patient eligibility criteria



Inclusion criteria

• Adult patients (18-70 years of age)
• AML (except acute promyelocytic leukemia, AML M3 and bcr/abl positive AML) according to WHO 2016 classification (Appendix A) or RAEB with IPSS-R ≥ 1.5 with high mutant to wild-type allelic ratio of FltFLT3-ITD
• First allogeneic HSCT scheduled within the next 2 months upon having achieved hematological remission (< 5% blasts at the bone marrow level)
• Matched sibling or matched unrelated donor (i.e. 10/10 or 9/10 HLA-matched) or haploidentical donor
• Using one of the following conditioning regimens:
Fludarabine/Cyclophosphamide/TBI 2 Gy in combination with post-Tx cyclophosphamide (TPT-CY) only
Fludarabine/Busulfan or Melphalan/Fludarabine/TBI or fludarabin/TBI 8 Gy with post-transplant cyclophosphamide.
• Strategies for GvHD prophylaxis:
HLA-matched donors:
PT-CY + CSA
Haploidentical donors:
PT-CY + CSA + MMF
• No history of significant cardiac disease and absence of active symptoms, otherwise documented left ventricular EF > 40%
• Negative serum pregnancy test for female patients of childbearing potential, at registration
• Female patients of childbearing potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
• Written informed consent


Exclusion criteria

• Known HIV or HCV positivity
• History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma “in situ” of the cervix or breast
• Pregnant or breast-feeding female patients


3. Registration (& randomization) of patients



Registration

Registration
Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top




4. Participating parties



5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
0
NL-Rotterdam-Erasmus MC - Centrum
2

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Patient Information & IC form (NL)



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