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NCT Number: NCT03818334

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

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).

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Key information

Conditions

Bone Marrow Transplant Complications Engraft Failure Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunologic Suppression Infection Viral Infections Neoplasms Neoplasms by Site Virus Diseases

Age range

1 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospita Israelita Albert Eintein

São Paulo, 05652-900, Brazil

Location status: Recruiting

Location contact

Mirele Santos

CONTACT

[email protected]

+112151-0305

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Cyclophosphamide

Drug

Cyclophosphamide 1000 mg/flask

Other names: Cytoxan

ATG

Drug

Antihuman T-Lymphocyte Immune Globulin 25 mg/flask

Other names: Thymoglobulin

Primary outcomes

  1. Overall Survival

    Time frame: 4 years

    Time to last follow-up or death

Secondary outcomes

  1. Progression free survival

    Time frame: 4 years

    Time until last follow-up, death or disease relapse

  2. Acute Graft Versus Host Disease

    Time frame: 4 years

    Time until acute GvHD development

  3. Chronic Graft Versus Host Disease

    Time frame: 4 years

    Time until chronic GvHD development

  4. Treatment Related Mortality

    Time frame: 4 years

    Time until death related to HSCT complications

Other outcomes

  1. Graft Failure Incidence

    Time frame: 2 years

    ANC < 500/microL after 42 days after graft infusion

  2. Time Until Neutrophil Engraftment

    Time frame: 2 years

    Time to ANC > 500/microL for three consecutive days

  3. Time Until Platelet Engraftment

    Time frame: 2 years

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

  4. Immunological Reconstitution

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

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

  5. Days hospitalized

    Time frame: First 100 days after graft infusion

    Days admitted to the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Andreza A Feitosa Ribeiro

CONTACT

[email protected]

+5511992512523

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Jan 28, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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