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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluBuBe | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| - Incidence of primary and secondary graft failure | Proportion of patients with primary and secondary graft failure defined by the absence of donor chimerism | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| - Incidence of HSCT-associated adverse events (safety and toxicity) | 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. | 125 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RM Gorbacheva Research Institute | Saint Petersburg | 197022 | Russia |
Request for sharing data with the study plan for the data will be evaluated under common conditions by Pavlov University Ethical Committee.
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| Bendamustine Hydrochloride |
| Drug |
130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT |
|
| Busulfan | Drug | 1 mg/kg po qid x 3 days, Days -5 through -3 |
|
| Cyclophosphamide | Drug | 50 mg/kg iv x 2 days, Days +3 through +4 |
|
| Mycophenolate Mofetil | Drug | 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35 |
|
| Tacrolimus 5Mg Cap | Drug | 0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml. |
|
| - Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence | Proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease | [ Time Frame: 100 days ] [ Designated as safety issue: Yes ] |
| - Incidence of acute GVHD grade II-IV | Cumulative incidence of patients with acute GVHD II-IV grade | 125 days |
| - Incidence of moderate and severe chronic GVHD | Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria. | 365 days |
| - Non-relapse mortality analysis | Cumulative incidence of patients with mortality without hematological relapse of malignancy | 2 years |
| - Overall survival analysis | Kaplan-Meier estimate of death from all causes | 2 years |
| - Event-free survival analysis | Kaplan-Meier estimate of death or relapse | 2 years |
| - Relapse rate analysis | Cumulative incidence of patients with relapse | 2 years |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015456 | Leukemia, Biphenotypic, Acute |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D000069461 | Bendamustine Hydrochloride |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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