Fludarabine
DrugFludarabine 30 mg/m2 x 5 days
Other names: Fludara
NCT Number: NCT00802113
The sequential combination of myeloablative therapy and autologous stem cell transplantation (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).
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Notify MeUp to 55 year
All sexes
Interventional
Phase 1 / Phase 2
Children's Memorial Hospital in Chicago, Chicago, Illinois, United States
Lymphomas are the third most common group of cancers in children and adolescents in the United States. While Hodgkin's Disease (HD) has been described for many years, some subtypes of the non-Hodgkin's Lymphomas (NHL) have only recently been described. Non-Hodgkin's lymphomas traditionally have been classified as low, intermediate or high grade based on their clinical aggressiveness. More recently they have been divided into two major subgroups indolent and aggressive lymphomas by the current National Cancer Institute (NCI/PDQ) reference. Among children, aggressive histologies are prevalent including small non-cleaved cell lymphoma, lymphoblastic lymphoma, and diffuse large cell lymphoma. The most common histologic classifications of childhood non-Hodgkin's lymphoma over the past 30 years has included the morphological schema developed by Rappaport, the morphologically and immunologically based schema of Lukes and Collins, the Kiel classifications, the prognostic sub-groupings of the National Cancer Institute's Working Formulation, and the most recently developed classification that utilizes morphological, immunophenotypic and genetic information in the Revised European-American Lymphoma (REAL) classification.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient must have adequate organ function as below
Disease Status (Eligibility)
Exclusion criteria
Fludarabine 30 mg/m2 x 5 days
Other names: Fludara
Busulfan 3.2 mg/kg/day x 2 days
Other names: Busulfex
Anti-Thymocyte Globulin 2.0 mg/kg/day x 4 days
Other names: ATG
Time frame: Up to 1 year post-transplantation
Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies.
Time frame: Up to 1 year post-transplantation
Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy.
Time frame: Up to 1 year post-transplantation
Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms.
Time frame: Up to 1 year post-transplantation
Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured.
Time frame: Up to 1 year post-transplantation
Following MAC AutoSCT, the median time to platelet recovery will be measured.
Time frame: Up to 1 year post-transplantation
The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome.
Time frame: Up to 1 year post-transplantation
Status as subjects died post-AlloHCT
Columbia University
Other
Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma and Hodgkin's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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