NCT00915811
Terminated
Phase 2
Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin
King's College Hospital NHS Trust1 site in 1 country20 target enrollmentJune 2007
Overview
- Phase
- Phase 2
- Intervention
- Fludarabine
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- King's College Hospital NHS Trust
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Treatment related mortality to Day 100
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling donors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient Selection
- •Availability of a HLA compatible sibling donor
- •Age \>18 years
- •Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
- •Poor risk acute myeloid leukaemia, de novo or transformed from MDS
- •Ineligibility for standard conditioning allograft due to age or co-existing morbidities
- •Donor selection
- •Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing.
Exclusion Criteria
- •Patient selection
- •Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
- •Hepatic disease, with AST \> 2 times normal.
- •Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted.
- •Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
- •Patients who have received previous treatment with Thymoglobuline
- •HIV-positive patients.
- •Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
- •Life expectancy severely limited by diseases other than MDS or MPD.
- •Serious concurrent untreated infection
Arms & Interventions
FBATG
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
Intervention: Fludarabine
FBATG
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
Intervention: Busulphan
FBATG
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
Intervention: Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme
FBATG
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
Intervention: Haematopoietic stem cell infusion
Outcomes
Primary Outcomes
Treatment related mortality to Day 100
Time Frame: Days 28, 56 and 100
Secondary Outcomes
- Incidence of single or multi-organ acute toxicity(Days 28, 56 and 100)
- Disease free survival/relapse risk(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Incidence of graft failure/rejection(Days 28, 56 and 100)
- Incidence of acute graft-versus-host disease(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Incidence of systemic infections(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- EBV activation(Fortnightly for first 6 weeks after transplantation and then weekly for the first 6 months.)
- Overall survival(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Early Phase 1
Fludarabine Based RIC for Bone Marrow Failure SyndromesBone Marrow Failure SyndromesNCT02928991Children's Hospital of Philadelphia25
Enrolling By Invitation
Phase 3
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic SyndromeAcute Myeloid Leukemia, AdultMyelodysplastic Syndrome(MDS)Allogeneic Hematopoietic Stem Cell TransplantationNCT05674539Wuhan Union Hospital, China200
Completed
Not Applicable
Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure DisordersAccelerated Phase Chronic Myelogenous LeukemiaAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaAplastic AnemiaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueFanconi AnemiaJuvenile Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaParoxysmal Nocturnal HemoglobinuriaPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Small Lymphocytic LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic LymphomaWaldenström MacroglobulinemiaNCT00856388Roswell Park Cancer Institute62
Unknown
Not Applicable
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell TransplantationMyelodysplastic SyndromeNCT01252784Cooperative Study Group A for Hematology20
Withdrawn
Phase 1
Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplant (HSCT) For LymphomaLymphomaNCT02724904Massachusetts General Hospital