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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 I/II feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AML


Status

planned


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

28


Study objectives

Primary objective:
To determine the safety and feasibility of midostaurin in combination with a fixed dose of panobinostat for patients with a high allelic ratio FLT3-ITD positive AML with treatment starting within 65 days after allogeneic HSCT and continued for one year

Secondary objectives:
To assess efficacy in terms of complete hematological remission rate, residual disease response rate, overall and progression free survival, chimerism, immune recovery, and toxicities.


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



6. Instruction videos



7. Download documentation / forms




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