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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHenry Ford Health System

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation

HIV positive; active hepatitis B or C

Patients with active uncontrolled infections.

Liver cirrhosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Bortezomib

    Drug

    GVHD prophylaxis

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: BortezomibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

engraftment rate

rate of neutrophil and platelet engraftment post stem cell transplant

Time frame
within 30 days post transplant

Secondary outcomes

Other outcomes

Sponsors and contacts

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