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

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10024349Term: Leukemia myeloidSystem Organ Class: 100000004864; MedDRA version: 20.1Level: LLTClassification code 10024330Term: Leukemia acuteSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003124-44-DE
• Lead Sponsor: DKMS gemeinnützige GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-31
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

- 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.
or
- HLA-compatible unrelated donor (=9/10 antigens matched for HLA-A, -B, -C, -DRB1, and –DQB1) with completed confirmatory typing
or
- 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:
-AML that evolves from previously documented myelodysplastic syndrome (MDS), or after a Myeloproliferative Neoplasia (MPN) or
Diagnosis of therapy-related myeloid neoplasm (t-MN)or
-Non favourable risk AML according to ELN-criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

- 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.
- Uncontrolled infection at the time of enrollment.
- History of allogeneic transplantation.
- Manifestation of AML in the central nervous system.
- Pregnant or breast-feeding women.
- Men unable or unwilling to use adequate contraception methods from start of study treatment to minimum of six months after the last dose of chemotherapy.
-Women with childbearing potential except those who fulfill the following criteria: Post-menopausal or post-operative or continuous and correct application of a contraception method with a Pearl Index < 1 % or sexual abstinence or vasectomy of the sexual partner.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified