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RecruitingNCT03818334Updated Feb 1, 2019

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

A Phase 2/3 interventional study of Cyclophosphamide and ATG in Bone Marrow Transplant Complications, Graft Versus Host Disease and Infection Viral, sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Open to participants aged 1 Year to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Hospital Israelita Albert Einstein · Phase 2/3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2021, 4 years 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2018; still recruiting 7 years 11 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
1 Year to 75 Years
Sex
All
01

Study summary

This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).

02

Conditions studied

  • Bone Marrow Transplant Complications
  • Graft Versus Host Disease
  • Infection Viral
  • Engraft Failure
  • Immunologic Suppression

Keywords

  • Bone Marrow Transplantation
  • Hematological Malignancies
  • Post-Cy
03

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

This study's planned enrollment of 50 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and Women of Any Age
  • Indication for an HSCT without matched sibling donor
  • Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)
  • Hematological malignancy

Exclusion criteria

Exclusion Criteria:

  • Acute leukemias not in complete response (that is > 5% blast in the bone marrow)
  • Chemorefractory lymphoproliferative disease
  • Active uncontrolled infection
  • HCT-CI > 3
  • Severe organic disfunction (heart ejection fraction \< 45%, glomerular filtration rate \< 50 mL.hour, pulmonary DLCO \< 50%)
  • Previous allogeneic bone marrow transplantation
  • Contraindication to cyclophosphamide or ATG
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Post Cyclophosphamide

    Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35

    Drug: Cyclophosphamide

  • Active comparator
    Thymoglobulin (ATG)

    Thymoglobulin (ATG) total dose 5 mg/Kg from day -4 until day -1 AND Calcineurin Inhibitor from day +5 AND Methotrexate on days +1, +3, +6 and +11

    Drug: ATG

Interventions

  • DrugCyclophosphamide

    Cyclophosphamide 1000 mg/flask

    Also known as: Cytoxan

  • DrugATG

    Antihuman T-Lymphocyte Immune Globulin 25 mg/flask

    Also known as: Thymoglobulin

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time to last follow-up or death

    Time frame: 4 years

Secondary outcomes

  1. Progression free survival

    Time until last follow-up, death or disease relapse

    Time frame: 4 years

  2. Acute Graft Versus Host Disease

    Time until acute GvHD development

    Time frame: 4 years

  3. Chronic Graft Versus Host Disease

    Time until chronic GvHD development

    Time frame: 4 years

  4. Treatment Related Mortality

    Time until death related to HSCT complications

    Time frame: 4 years

Other outcomes

  1. Graft Failure Incidence

    ANC \< 500/microL after 42 days after graft infusion

    Time frame: 2 years

  2. Time Until Neutrophil Engraftment

    Time to ANC \> 500/microL for three consecutive days

    Time frame: 2 years

  3. Time Until Platelet Engraftment

    Time to platelet count \> 50,000/microL, without transfusion in the last 7 days

    Time frame: 2 years

  4. Immunological Reconstitution

    Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)

    Time frame: Days +60, +100 and +180

  5. Days hospitalized

    Days admitted to the hospital

    Time frame: First 100 days after graft infusion

07

Study locations

1 of 1 sites recruiting
  • Hospita Israelita Albert Eintein
    São Paulo, SP 05652-900, Brazil
    Recruiting
08

References and documents

Publications

  • Finke J, Schmoor C, Bethge WA, Ottinger HD, Stelljes M, Zander AR, Volin L, Heim DA, Schwerdtfeger R, Kolbe K, Mayer J, Maertens JA, Linkesch W, Holler E, Koza V, Bornhauser M, Einsele H, Bertz H, Grishina O, Socie G; ATG-Fresenius Trial Group. Prognostic factors affecting outcome after allogeneic transplantation for hematological malignancies from unrelated donors: results from a randomized trial. Biol Blood Marrow Transplant. 2012 Nov;18(11):1716-26. doi: 10.1016/j.bbmt.2012.06.001. Epub 2012 Jun 17. PubMed 22713691 ↗
  • Bacigalupo A, Lamparelli T, Barisione G, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Sacchi N, van Lint MT, Bosi A; Gruppo Italiano Trapianti Midollo Osseo (GITMO). Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation. Biol Blood Marrow Transplant. 2006 May;12(5):560-5. doi: 10.1016/j.bbmt.2005.12.034. PubMed 16635791 ↗
  • Devillier R, Labopin M, Chevallier P, Ledoux MP, Socie G, Huynh A, Bourhis JH, Cahn JY, Roth-Guepin G, Mufti G, Desmier D, Michallet M, Fegueux N, Ciceri F, Baron F, Blaise D, Nagler A, Mohty M. Impact of antithymocyte globulin doses in reduced intensity conditioning before allogeneic transplantation from matched sibling donor for patients with acute myeloid leukemia: a report from the acute leukemia working party of European group of Bone Marrow Transplantation. Bone Marrow Transplant. 2018 Apr;53(4):431-437. doi: 10.1038/s41409-017-0043-y. Epub 2018 Jan 12. PubMed 29330391 ↗
  • Saber W, Opie S, Rizzo JD, Zhang MJ, Horowitz MM, Schriber J. Outcomes after matched unrelated donor versus identical sibling hematopoietic cell transplantation in adults with acute myelogenous leukemia. Blood. 2012 Apr 26;119(17):3908-16. doi: 10.1182/blood-2011-09-381699. Epub 2012 Feb 10. PubMed 22327226 ↗
  • Mehta RS, Saliba RM, Chen J, Rondon G, Hammerstrom AE, Alousi A, Qazilbash M, Bashir Q, Ahmed S, Popat U, Hosing C, Khouri I, Shpall EJ, Champlin RE, Ciurea SO. Post-transplantation cyclophosphamide versus conventional graft-versus-host disease prophylaxis in mismatched unrelated donor haematopoietic cell transplantation. Br J Haematol. 2016 May;173(3):444-55. doi: 10.1111/bjh.13977. Epub 2016 Mar 7. PubMed 26947769 ↗
  • Rashidi A, Slade M, DiPersio JF, Westervelt P, Vij R, Romee R. Post-transplant high-dose cyclophosphamide after HLA-matched vs haploidentical hematopoietic cell transplantation for AML. Bone Marrow Transplant. 2016 Dec;51(12):1561-1564. doi: 10.1038/bmt.2016.217. Epub 2016 Aug 15. PubMed 27526282 ↗
  • Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bondarenko SN, Afanasyev BV. Graft-versus-Host Disease Prophylaxis in Unrelated Peripheral Blood Stem Cell Transplantation with Post-Transplantation Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. Biol Blood Marrow Transplant. 2016 Jun;22(6):1037-1042. doi: 10.1016/j.bbmt.2016.03.004. Epub 2016 Mar 10. PubMed 26970381 ↗
  • Kanakry CG, Bolanos-Meade J, Kasamon YL, Zahurak M, Durakovic N, Furlong T, Mielcarek M, Medeot M, Gojo I, Smith BD, Kanakry JA, Borrello IM, Brodsky RA, Gladstone DE, Huff CA, Matsui WH, Swinnen LJ, Cooke KR, Ambinder RF, Fuchs EJ, de Lima MJ, Andersson BS, Varadhan R, O'Donnell PV, Jones RJ, Luznik L. Low immunosuppressive burden after HLA-matched related or unrelated BMT using posttransplantation cyclophosphamide. Blood. 2017 Mar 9;129(10):1389-1393. doi: 10.1182/blood-2016-09-737825. Epub 2017 Jan 3. PubMed 28049637 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03818334
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
Andreza Alice Feitosa Ribeiro (Assistant Physician specialist in Hematopoietic Stem Transplantation, Principal Investigator, Hospital Israelita Albert Einstein) — Principal investigator
First posted
Jan 28, 2019
Start date
Nov 6, 2018
Primary completion
Nov 1, 2021 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Feb 1, 2019

Study contacts

Andreza A Feitosa Ribeiro
Contact
andreza.ribeiro@einstein.br
+5511992512523
Andreza A Feitosa Ribeiro, PhD
principal investigator · Hospital Israelita Albert Einstein
Nelson Hamerschlak, PhD
study chair · Hospital Israelita Albert Einstein

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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