Lymphoma, Non-Hodgkin Clinical Trial
— Haplo/CordOfficial title:
Phase II Study: HSCT Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
This study is a means of providing transplantation to those patients who would be a stem
cell transplant candidate who do not have an appropriate donor.
The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide
earlier engraftment without the need for long term immunosuppression.
This study tests a new method of bone marrow transplantation called combined
haploidentical-cord blood transplantation. In this procedure, some of the blood forming
cells (the stem cells) from a partially human leukocyte antigen (HLA) matched
(haploidentical) related donor are collected from the blood, as well as cells from an
umbilical cord are transplanted into the patient (the recipient) after administration of a
"conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes
radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the
cancer cells and suppress the recipient's immune system to allow the transplanted cells to
take (grow).
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients between 18 and 65 years old - Patient has a related family member(haploidentical) or unrelated which is 5 of 10 HLA identical match. Standard Risk - Acute myelogenous leukemia: CR1 with high risk cytogenetics or molecular abnormalities such as FLT-3 ITD, or CR2 with a first remission that must have lasted > 1 year. - Acute Lymphocytic Leukemia: CR1, in order to be standard risk must NOT have Philadelphia Chromosome. - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory to fludarabine or fail to have a complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog). - Chronic myelogenous leukemia: resistant to or intolerant of TKI, in CP1 or CP2, or with a mutation that suggests resistance to TKI. - Myelodysplastic Syndrome: RA, RARS, must be IPSS = INT-2, Blasts <5%. High Risk Patients: - Acute myelogenous leukemia: Patients with CR2 are considered high risk if they have high risk cytogenetics, or molecular abnormalities or CR1 lasted for less than 1 year. Any evidence of active disease or no blasts in an acellular marrow. - Acute Lymphocytic Leukemia: CR1- with Ph+ disease, CR2/+ with any cytogenetics. Any evidence of active disease. - Chronic myelogenous leukemia- CP2/+, AP1/+, resistant or intolerant to TKI. - Hodgkin's or Non Hodgkin's lymphoma- Disease recurrence following an autologous transplant, or high risk disease not thought to benefit from autologous transplant. - Chronic lymphocytic leukemia- that is resistant to fludarabine, and never has been in remission or with stable disease/progressive disease - Multiple myeloma: Must have had prior treatment. Patients in CR2 or greater can be considered, must have already failed autologous transplant Previous autologous transplant,must have been greater than 6 months prior to undergoing this transplant. - Myelodysplastic syndrome: RAEB - Other Myeloproliferative disorders including myelofibrosis, spent phase p Vera,Essential thrombocytosis,CMML. Exclusion Criteria: - Patients <18 years old Disease related criteria - APML, presence of t(15,17) in first CR - Patients with good risk AML, for example t(8;21), or inv 16, or normal cytogenetics with FLT-3-ITD negative, NPM-1 positive disease in 1st CR - MDS IPSS < INT-2 Miscellaneous Criteria - Recipients who have a matched related sibling or unrelated donor - If recipient has evidence of anti-HLA antibodies directed against cord or haplo-donor as determined byflowPRA. Underlying health criteria: - Zubrod performance status > 2 (see Appendix E) - Life expectancy is limited to less than 8 weeks by concomitant illness - Patients with severely decreased LVEF (EF < 40%) - Impaired pulmonary function tests (PFT's) (FVC, FEV1, DLCO < 45% predicted) - Estimated Creatinine Clearance <50 ml/min - Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal - Evidence of chronic active hepatitis or cirrhosis - HIV-positive - Patient is pregnant - Patient or guardian not able to provide informed consent |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata. | 3 years | No | |
Secondary | Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant | NOT analyzed since there was only patient and no relapse was observed till patient passed away | 2 years | No |
Secondary | Time to Neutrophil Engraftment: To Assess the Incidence of Neutrophil Engraftment From Day of Transplant | time to neutrophil recovery after transplant | 100 days | No |
Secondary | Time to Platelet Engraftment: To Assess the Incidence of Platelet Engraftment From Day of Transplant, | 100 days | No | |
Secondary | Time to Acute GVHD: We Will Assess the Incidence and Severity of Grades II-IV and Grades III-IV Acute GVHD From Day of Transplant. | 100 days | No | |
Secondary | Transplant Related Mortality (TRM): TRM is Death Occurring in Patients in Continuous Complete Remission. | 1 year | Yes | |
Secondary | Disease-free Survival:Death or Relapse Will be Considered Events for This Endpoint. | 3 years | No |
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