EUCTR2021-004730-11-AT
Active, not recruiting
Phase 1
A prospective, controlled, single-arm pilot study on treosulfan, fludarabine, and cyclophosphamide (TreoFC) as conditioning treatment before haploidentical hematopoietic stem cell transplantation for older patients with acute myeloid leukemia or myelodysplastic syndrome
ConditionsConditioning therapy before haploidentical hematopoietic stem cell transplantationMedDRA version: 22.0Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Conditioning therapy before haploidentical hematopoietic stem cell transplantation
- Sponsor
- Medical University of Vienna
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with acute myeloid leukemia (AML) according to WHO 2016 (AML in complete remission at transplant, i.e., blast counts \<5% in bone marrow) or myelodysplastic syndrome according to WHO 2016 (MDS with blast counts \<20 % in bone marrow during disease history) indicated for haploidentical HSCT but considered to be at increased risk for standard conditioning therapies according to the following criteria:
- •patients aged \=50 years at transplant and/or
- •patients with an HCT\-CI score \>2 \[according to Sorror et al., 2005]
- •2\.Availability of a haploidentical (HLA match \=5/10\) first\- or second\-degree related donor. Donor selection is based on molecular high\-resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low\-resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA\- A, B, and C gene loci.
- •3\.Adult patients of both gender, age 18\-70 years
- •4\.Karnofsky Index \=60 %
- •5\.Written informed consent
- •6\.Men capable of reproduction and women of childbearing potential must be willing to consent to use a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or vasectomized partner while on treatment and for at least 6 months thereafter
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.Availability of matched sibling donor eligible for stem cell donation
- •2\.Patients with acute promyelocytic leukemia with t(15;17\)(q22;q12\) and in CR1
- •3\.Patients considered contraindicated for HSCT due to severe concomitant illness (within 3 weeks before scheduled day \-6\):
- •patients with severe renal impairment like patients on dialysis or prior renal transplantation or S\-creatinine \>3\.0 x ULN or calculated creatinine\-clearance \< 60 ml/min
- •patients with severe pulmonary impairment, DLCOsb (Hb\-adjusted)/or FEV1 \<50 % or severe dyspnoea at rest or requiring oxygen supply
- •patients with severe cardiac impairment diagnosed by echocardiography and LVEF \<40 %
- •patients with severe hepatic impairment indicated by hyperbilirubinemia \>3x ULN or ALT/AST \>5 x ULN
- •4\.Active malignant involvement of the CNS
- •5\.HIV\-positivity, active non\-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
- •6\.Previous allogeneic HSCT
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Aquablation Pilot Study for the treatment of Benign Prostatic Hyperplasia.ACTRN12613000167763PROCEPT BioRobotics Corporation30
Not yet recruiting
Phase 2
A Clinical Study to Evaluate the Efficacy of Siddha Medicines in Bronchial AsthmaCTRI/2024/03/064944Central Council for Research in Siddha, Ministry of Ayush, Govt. of India40
Completed
Not Applicable
A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasisISRCTN51850035Department of Health50
Active, not recruiting
Not Applicable
sing Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsMultiple SclerosisMedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2013-001439-34-DEGenzyme Corporation1,000
Active, not recruiting
Phase 1
sing Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsMultiple SclerosisTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2013-001439-34-ESGenzyme Corporation1,001