Evaluation of the impact of remission induction chemotherapy prior to allogeneic stem cell transplantation in relapsed and poor-response patients with AML - ETAL3-ASAP

DKMS gemeinnützige GmbH0 sites308 target enrollmentJuly 31, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2014

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

DKMS gemeinnützige GmbH

•\- Signed written informed consent.
•\- Male and female patients of 18 to 75 years of age.
•\- Diagnosis of AML according to WHO criteria.
•\- Patient is fit for aggressive induction chemotherapy and transplantation by assessment of an experienced hematologist.
•\- No known history of chronic pulmonary disease and absence of dyspnea. Otherwise, documented diffusion lung capacity for carbon monoxide (DLCO) \=40% (adjusted for hemoglobin, if available) and FEV1/FVC \= 50%.
•\- HLA\-identical sibling.
•\- HLA\-compatible unrelated donor (\=9/10 antigens matched for HLA\-A, \-B, \-C, \-DRB1, and –DQB1\) with completed confirmatory typing
•\- Two unrelated donors with \>90% probability of 9/10 match for HLA\-A, \-B, \-C, \-DRB1, and –DRQB1, according to OptiMatch® list.
•\- Relapse patients: First AML relapse, defined as \=5% bone marrow blasts and / or extramedullary AML manifestation.
•\- Poor\-responders: with \=5% bone marrow blasts after the first cycle of induction therapy, and one of the following subtypes/risk groups of AML:

•\- Acute promyelocytic leukemia (APL).
•WBC count of \=50 GPt/L at study inclusion.
•\- For poor\-responder patients the first cycle of induction therapy contained HDAC, defined as cytarabine at single\-doses of \>1g/ m2\.
•\- Patient has received more than 440 mg/m2 daunorubicin equivalents
•\- Severe organ dysfunction, defined as any of the following:
•Left ventricular ejection fraction \<50%.
•Patients who receive supplementary continuous oxygen.
•Serum bilirubin \>1\.5 x ULN (if not considered Gilbert\-Syndrome), or ASAT/ALAT \>5 x ULN.
•Estimated GFR \< 50 ml/min.
•\- Treatment with any investigational drug within 10 days before study entry.