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Trial record 1 of 4 for:    ANDREZA | Brazil
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Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03818334
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Andreza Alice Feitosa Ribeiro, Hospital Israelita Albert Einstein

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).

Condition or disease Intervention/treatment Phase
Bone Marrow Transplant Complications Graft Versus Host Disease Infection Viral Engraft Failure Immunologic Suppression Drug: Cyclophosphamide Drug: ATG Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

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 Name: 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 Name: Thymoglobulin

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 4 years ]
    Time to last follow-up or death

Secondary Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03818334

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Contact: Andreza A Feitosa Ribeiro +5511992512523

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Hospita Israelita Albert Eintein Recruiting
São Paulo, SP, Brazil, 05652-900
Contact: Mirele Santos    +112151-0305   
Sponsors and Collaborators
Hospital Israelita Albert Einstein
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Principal Investigator: Andreza A Feitosa Ribeiro, PhD Hospital Israelita Albert Einstein
Study Chair: Nelson Hamerschlak, PhD Hospital Israelita Albert Einstein

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Responsible Party: Andreza Alice Feitosa Ribeiro, Assistant Physician specialist in Hematopoietic Stem Transplantation, Principal Investigator, Hospital Israelita Albert Einstein Identifier: NCT03818334    
Other Study ID Numbers: SGPP 3549-18
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreza Alice Feitosa Ribeiro, Hospital Israelita Albert Einstein:
Bone Marrow Transplantation
Hematological Malignancies
Additional relevant MeSH terms:
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Virus Diseases
Hematologic Neoplasms
Graft vs Host Disease
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists