Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant

NCT02300571 | Unknown

• 1 other identifier: HDCTX 2013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study is proposed to observe the effect of high-dose, post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or mismatched donor.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Incidence of the observed GVHD rate and infections

  Evaluations through day 100 after transplantation will be performed with: 1. Complete blood count (CBC), including differential and platelet count per standard practice guidelines at the performance site. 2. Blood chemistries: including sodium, potassium, chloride, bicarbonate (HCO3) or total carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), creatinine, calcium, magnesium, phosphorus, total bilirubin, total protein, albumin, serum glutamic oxaloacetic transaminase (SGOT), lactic dehydrogenase (LDH), alkaline phosphatase per standard practice guidelines at the performance site. Tacrolimus whole blood concentrations weekly starting on day 6. CMV surveillance, Aspergillus surveillance will be performed per standard practice guidelines at the performance site. Evaluations after 100 days post-transplant will be completed per standard practice guidelines at each performance site.

  100 day

Secondary Outcomes (2)

• Overall survival

  1 years

• Progression-free survival

  1 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Hematological Malignancies Eligible to Allogeneic Hematopoietic Stem Cell Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical or partially mismatched donors

You may qualify if:

• Patient is scheduled for transplant of 'mobilized' peripheral blood stem cells (PBSC) from a genotypically HLA-unrelated or related identical or partially mismatched stem cell donor.
• Patient is ≥ 18 years and ≤ 65 years of age.
• Diagnosis of malignancy. Patients will be divided on the basis of their disease in low risk and high risk patients.
• High risk diseases: AML \> CR1, ALL \> CR1, CML in CP #2, AP or BP, non-Hodgkin's lymphoma \> CR2, Hodgkin's lymphoma \> CR2, other patient with refractory malignancy Low risk: multiple myeloma (all patients), AML in CR1, myelodysplastic syndrome beyond RA (including CMML) and ALL in CR1.
• Patient or legal guardian has signed/dated the informed consent form.
• Female patients must have a negative pregnancy test (blood or urine) unless they are prepuberal or surgically sterile.
• Estimated Creatinine Clearance ≥ 60 mL/min at time of consent.
• Total bilirubin is ≤ 1.5 times the upper limit of normal at time of consent.
• SGOT and SGPT are ≤ 2.0 times the upper limit of normal at time of consent.

You may not qualify if:

• Patient \> 65 years of age
• Patient has not signed/dated the informed consent form.
• Patient is receiving a T-cell depleted hematopoietic stem cell graft.
• Pregnant or lactating women
• Patient has an acute pulmonary infection suspected on the basis of abnormal chest x-ray.
• Patient has an active systemic infection not controlled with anti-microbial therapy.
• Patient is a known carrier of any of the Human Immune Deficiency Viruses (HIV-1 or others).

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (2)

Fondazione del Piemonte per l'Oncologia

Candiolo, 10060, Italy

RECRUITING

Ospedale Regina Margherita

Torino, 10126, Italy

NOT YET RECRUITING

Related Publications (2)

• Carnevale-Schianca F, Caravelli D, Gallo S, Becco P, Paruzzo L, Poletto S, Polo A, Mangioni M, Salierno M, Berger M, Pessolano R, Saglio F, Gottardi D, Rota-Scalabrini D, Grignani G, Fizzotti M, Ferrero I, Frascione PMM, D'Ambrosio L, Gaidano V, Gammaitoni L, Sangiolo D, Saglietto A, Vassallo E, Cignetti A, Aglietta M, Fagioli F. Post-Transplant Cyclophosphamide and Tacrolimus-Mycophenolate Mofetil Combination Governs GVHD and Immunosuppression Need, Reducing Late Toxicities in Allogeneic Peripheral Blood Hematopoietic Cell Transplantation from HLA-Matched Donors. J Clin Med. 2021 Mar 11;10(6):1173. doi: 10.3390/jcm10061173.

  PMID: 33799685 DERIVED

• Carnevale-Schianca F, Caravelli D, Gallo S, Coha V, D'Ambrosio L, Vassallo E, Fizzotti M, Nesi F, Gioeni L, Berger M, Polo A, Gammaitoni L, Becco P, Giraudo L, Mangioni M, Sangiolo D, Grignani G, Rota-Scalabrini D, Sottile A, Fagioli F, Aglietta M. Post-Transplant Cyclophosphamide and Tacrolimus-Mycophenolate Mofetil Combination Prevents Graft-versus-Host Disease in Allogeneic Peripheral Blood Hematopoietic Cell Transplantation from HLA-Matched Donors. Biol Blood Marrow Transplant. 2017 Mar;23(3):459-466. doi: 10.1016/j.bbmt.2016.12.636. Epub 2016 Dec 27.

  PMID: 28039079 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Massimo Aglietta, MD

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

• Franca Fagioli, MD

  Ospedale Regina Margherita

  STUDY CHAIR

• Fabrizio Carnevale-Schianca, MD

  Fondazione del Piemonte per l'Oncologia

  STUDY CHAIR

Central Study Contacts

Fabrizio Carnevale-Schianca, MD

CONTACT

+39011993; fabrizio.carnevale@ircc.it

Daniela Caravelli, MD

CONTACT

+39011993; daniela.caravelli@ircc.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

IT (2)