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Recruiting Phase 2 NCT03850366

HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib

Trial Parameters

Condition Hematological Malignancy
Sponsor Henry Ford Health System
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2016-03-08
Completion 2028-01-01
Interventions
Bortezomib

Brief Summary

Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib

Eligibility Criteria

Inclusion Criteria: * 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified * Candidate for stem cell transplant in a malignant hematological condition * Karnofsky Performance Scale 0-1 * Available donor able to undergo a Peripheral blood stem cells collection * Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults. * Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula) * Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin. * Left ventricle ejection fraction \> 40%. * Patient or patient's legal representative, parent(s) or guardian should provide written informed consent. Exclusion Criteria: * Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable d

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