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New treatment option for Bone Marrow Transplant Complications
Official title Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
ClinicalTrials.gov ID: NCT03818334
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for bone marrow transplant complications.
Also referred to as Cytoxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.