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

Primary Purpose

Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cyclophosphamide
ATG
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Marrow Transplant Complications focused on measuring Bone Marrow Transplantation, Hematological Malignancies, Post-Cy

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospita Israelita Albert EinteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Post Cyclophosphamide

Thymoglobulin (ATG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival
Time to last follow-up or death

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2019
Last Updated
January 31, 2019
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT03818334
Brief Title
Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral, Engraft Failure, Immunologic Suppression
Keywords
Bone Marrow Transplantation, Hematological Malignancies, Post-Cy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post Cyclophosphamide
Arm Type
Experimental
Arm Description
Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35
Arm Title
Thymoglobulin (ATG)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
Cyclophosphamide 1000 mg/flask
Intervention Type
Drug
Intervention Name(s)
ATG
Other Intervention Name(s)
Thymoglobulin
Intervention Description
Antihuman T-Lymphocyte Immune Globulin 25 mg/flask
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time to last follow-up or death
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Time until last follow-up, death or disease relapse
Time Frame
4 years
Title
Acute Graft Versus Host Disease
Description
Time until acute GvHD development
Time Frame
4 years
Title
Chronic Graft Versus Host Disease
Description
Time until chronic GvHD development
Time Frame
4 years
Title
Treatment Related Mortality
Description
Time until death related to HSCT complications
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Graft Failure Incidence
Description
ANC < 500/microL after 42 days after graft infusion
Time Frame
2 years
Title
Time Until Neutrophil Engraftment
Description
Time to ANC > 500/microL for three consecutive days
Time Frame
2 years
Title
Time Until Platelet Engraftment
Description
Time to platelet count > 50,000/microL, without transfusion in the last 7 days
Time Frame
2 years
Title
Immunological Reconstitution
Description
Total lymphocyte count as well as its subsets (CD4, CD8, CD19, CD56)
Time Frame
Days +60, +100 and +180
Title
Days hospitalized
Description
Days admitted to the hospital
Time Frame
First 100 days after graft infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreza A Feitosa Ribeiro
Phone
+5511992512523
Email
andreza.ribeiro@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreza A Feitosa Ribeiro, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelson Hamerschlak, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Study Chair
Facility Information:
Facility Name
Hospita Israelita Albert Eintein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirele Santos
Phone
+112151-0305
Email
mirele.santos@einstein.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

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