Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥ 18 ≤ 75 years old

CB unit transplantation (TNC> 2,0 x10^7/kg and > 4/6 loci HLA matched)

Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine

GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF

Disqualifiers

Positive serologic markers for human immunodeficiency virus (HIV)

Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

Trial population

Patients with no matched (\<7/8 HLA loci) sibling or unrelated donor, candidate to receive a transplant of a matched CB unit (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • CB transplantation

    Procedure/Surgery

    Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

hematopoietic reconstitution

number of days for neutrophil (\> 0.5x10\^9/L) and platelet (\> 20x10\^9/L) engraftment

Time frame
first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L

Secondary outcomes

1

immune reconstitution

number of CD4+cells at day 100

Time frame
day 100 from transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.