Clinical trial NCT03818334: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Bone Marrow Transplant Complications
Graft Versus Host Disease
Infection Viral
Engraft Failure
Immunologic Suppression
Keywords: Bone Marrow Transplantation
Hematological Malignancies
Post-Cy
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Overall Survival
timeFrame: 4 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 4 years
measure: Acute Graft Versus Host Disease
timeFrame: 4 years
measure: Chronic Graft Versus Host Disease
timeFrame: 4 years
measure: Treatment Related Mortality
timeFrame: 4 years
Other outcomes:
measure: Graft Failure Incidence
timeFrame: 2 years
measure: Time Until Neutrophil Engraftment
timeFrame: 2 years
measure: Time Until Platelet Engraftment
timeFrame: 2 years
measure: Immunological Reconstitution
timeFrame: Days +60, +100 and +180
measure: Days hospitalized
timeFrame: First 100 days after graft infusion
Locations:
city: São Paulo
country: Brazil
facility: Hospita Israelita Albert Eintein
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Andreza A Feitosa Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Nelson Hamerschlak, PhD
role: STUDY_CHAIR
References:
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