Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Myeloid

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Leukemia, Biphenotypic, Acute

Leukemia, Lymphoid

Leukemia, Myeloid, Acute

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Disease Attributes

Myeloid Leukemia

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Acute Leukemia of Ambiguous Lineage

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Bendamustine Hydrochloride

Mycophenolic Acid

Tacrolimus

Busulfan

Antineoplastic Agents, Alkylating

Immunosuppressive Agents

Immunologic Factors

Alkylating Agents

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days; Days -7 through -6: Bendamustine 130 mg/m2 iv x 2 days; Days -5 through -3: Busulfan 1 mg/kg po qid x 3 days; Days +3 through +4: Cyclophosphamide 50 mg/kg iv x 2 days; Days +5 through +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days; Days +5 through +150: Tacrolimus 0.03 mg/kg/day with further correction by concentration

30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT

130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT

1 mg/kg po qid x 3 days, Days -5 through -3

45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35

Mycophenolate Mofetil

0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml.

Tacrolimus 5Mg Cap

Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft.

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Request for sharing data with the study plan for the data will be evaluated under common conditions by Pavlov University Ethical Committee.

Proportion of patients with primary and secondary graft failure defined by the absence of donor chimerism

Toxicity assessment is based on NCI CTC AE 5.0 grades. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2016. Transplant-associated microangiopathy incidence assessment is based on Cho et al. criteria. All toxicity measurements will be aggregated as severity scores.

Proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease

Cumulative incidence of patients with acute GVHD II-IV grade

Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria.

Cumulative incidence of patients with mortality without hematological relapse of malignancy

Kaplan-Meier estimate of death from all causes

Kaplan-Meier estimate of death or relapse

Cumulative incidence of patients with relapse

Spots Global Cancer Trial Database for tacrolimus 5mg cap