Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT01760655|
Recruitment Status : Recruiting
First Posted : January 4, 2013
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Blastic Phase Chronic Myelogenous Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Childhood Burkitt Lymphoma Childhood Chronic Myelogenous Leukemia Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Childhood Myelodysplastic Syndromes Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Myelomonocytic Leukemia Chronic Phase Chronic Myelogenous Leukemia Cutaneous B-cell Non-Hodgkin Lymphoma de Novo Myelodysplastic Syndromes Essential Thrombocythemia Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Juvenile Myelomonocytic Leukemia Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Polycythemia Vera Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Refractory Cytopenia With Multilineage Dysplasia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Waldenström Macroglobulinemia||Drug: Fludarabine phosphate Drug: Thiotepa Radiation: Total body irradiation Biological: Therapeutic allogeneic lymphocytes Drug: Cyclophosphamide Procedure: Allogeneic hematopoietic stem cell transplantation (HSCT) Procedure: Peripheral blood stem cell transplantation Drug: Tacrolimus Drug: Mycophenolate mofetil||Phase 2|
1. To compare the rate of disease-free survival (DFS) at 1 year post hematopoietic stem cell transplant (HSCT) in patients undergoing HSCT treated on this successor Thomas Jefferson University (TJU) 2 Step reduced intensity conditioning (RIC) haploidentical regimen and compare it with that of the initial 2 Step RIC regimen.
- To assess the 100 day regimen-related mortality (RRM) in patients undergoing HSCT on this treatment protocol.
- To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen.
- To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.
- To assess overall survival at 1 and 3 years past HSCT in patients treated on this trial.
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -15 to -12, thiotepa IV over 2 hours on days -15 to -13, donor lymphocyte infusion (DLI) on day -6, and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total-body irradiation (TBI) on day -10.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV twice daily (BID) on days -1 to 28.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic Malignancies|
|Actual Study Start Date :||December 24, 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Treatment (RIC and stem cell transplant)
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -15 to -12, thiotepa IV over 2 hours on days -15 to -13, donor lymphocyte infusion (DLI) on day -6, and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28.
Drug: Fludarabine phosphate
Other Names:Drug: Thiotepa
Other Names:Radiation: Total body irradiation
Other Name: TBIBiological: Therapeutic allogeneic lymphocytes
Undergo donor lymphocyte infusion
Other Names:Drug: Cyclophosphamide
Other Names:Procedure: Allogeneic hematopoietic stem cell transplantation (HSCT)
Undergo allogeneic PBSCTProcedure: Peripheral blood stem cell transplantation
Undergo allogeneic PBSCT
Other Names:Drug: Tacrolimus
Other Names:Drug: Mycophenolate mofetil
- Disease-free survival (DFS) [ Time Frame: 1 year ]The primary null hypothesis is that 1 year DFS rate is at most 35%. 35% is the rounded number (actual 36%) representing the DFS at 1 year of patients treated on the initial TJU 2 Step RIC HSCT trial and consistent with the outcome of patients treated on similar protocols outside of our institution.
- Overall survival [ Time Frame: 1 year and 3 years ]
- Incidence of Regimen Related Toxicity [ Time Frame: Up to 1 year ]Graded according to the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0
- Immune reconstitution [ Time Frame: Up to 1 year ]
- Incidence and degree of GVHD [ Time Frame: Up to 1 year ]
- Engraftment rates [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760655
|Contact: Dolores Grosso, RN, CRNP, DNP||215-955-8874|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Dolores Grosso, RN, CRNP, DNP 215-955-8874|
|Principal Investigator: Dolores Grosso, RN, CRNP, DNP|
|Principal Investigator: Neal Flomenberg, MD|
|Sub-Investigator: S. Onder Alpdogan, MD|
|Sub-Investigator: Matthew Carabasi, MD|
|Sub-Investigator: Joanne Filicko-O'Hara, MD|
|Sub-Investigator: Margaret Kasner, MD|
|Sub-Investigator: William O'Hara, PharmD|
|Sub-Investigator: Ubaldo Outschoorn Martinez, MD|
|Sub-Investigator: John Wagner, MD|
|Sub-Investigator: Mark Weiss, MD|
|Principal Investigator:||Dolores Grosso, RN, CRNP, DNP||Thomas Jefferson University|
|Principal Investigator:||Neal Flomenberg, MD||Thomas Jefferson University|