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

January 31, 2019 updated by: Andreza Alice Feitosa Ribeiro, Hospital Israelita Albert Einstein

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05652-900
        • Recruiting
        • Hospita Israelita Albert Eintein
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Cyclophosphamide 1000 mg/flask
Other Names:
  • Cytoxan
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
Antihuman T-Lymphocyte Immune Globulin 25 mg/flask
Other Names:
  • Thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 4 years
Time to last follow-up or death
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 4 years
Time until last follow-up, death or disease relapse
4 years
Acute Graft Versus Host Disease
Time Frame: 4 years
Time until acute GvHD development
4 years
Chronic Graft Versus Host Disease
Time Frame: 4 years
Time until chronic GvHD development
4 years
Treatment Related Mortality
Time Frame: 4 years
Time until death related to HSCT complications
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Failure Incidence
Time Frame: 2 years
ANC < 500/microL after 42 days after graft infusion
2 years
Time Until Neutrophil Engraftment
Time Frame: 2 years
Time to ANC > 500/microL for three consecutive days
2 years
Time Until Platelet Engraftment
Time Frame: 2 years
Time to platelet count > 50,000/microL, without transfusion in the last 7 days
2 years
Immunological Reconstitution
Time Frame: Days +60, +100 and +180
Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)
Days +60, +100 and +180
Days hospitalized
Time Frame: First 100 days after graft infusion
Days admitted to the hospital
First 100 days after graft infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Andreza A Feitosa Ribeiro, PhD, Hospital Israelita Albert Einstein
  • Study Chair: Nelson Hamerschlak, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2018

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2026

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (ACTUAL)

January 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGPP 3549-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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