Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Antecedent hematological disease (e.g., myelodysplasia (MDS))
Treatment-related
Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)
Participants must be in CR1, CR2, CR3 or CRi
Disqualifiers
Creatinine clearance < 40ml/min (Cockcroft-Gault)
Bilirubin > 2X institutional upper limit of normal unless Gilbert syndrome
AST (SGOT) > 3X institutional upper limit of normal
ALT (SGPT) > 3X institutional upper limit of normal
Trial design
Design model
Single group
Treatments tested in this trial
Haplo-Identical / Cord Blood Transplant
Biological/VaccineCord Blood Unit Selection Cord Blood Unit Selection should be consistent with published guidelines5 with the understanding that the goal cell dose is 1x105 CD34 cells/kg in this protocol. ABO matching and donor specific antibodies should be taken into account in the selection of the CB unit. Haplo-Donor Selection Haplo-identical siblings and younger male donors are preferred. ABO matching, CMV compatibility, and donor specific antibodies should be taken into account in the selection of the donor.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Haplo-Identical / Cord Blood TransplantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival(PFS) at 6 months after transplant
Kaplan-Meier method will be used to estimate the PFS
Time frame
6 months after transplantSecondary outcomes
1
Progression free survival at 1 year after transplant
Kaplan-Meier method will be used to estimate the PFS
Time frame
1 year after transplant2
Progression free survival at 2 years after transplant
Kaplan-Meier method will be used to estimate the PFS
Time frame
2 years after transplant3
Progression free survival at 3 years after transplant
Kaplan-Meier method will be used to estimate the PFS
Time frame
3 years after transplant4
Non-relapse mortality at 1 year after transplant
Time frame
1 year after transplantSponsors and contacts
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Source ClinicalTrials.gov