Phase 2
Completed N=33
Reduced Intensity Double Umbilical Cord Blood Transplantation
Source: ClinicalTrials.gov NCT01408563 ↗Enrolled (actual)
33
Serious AEs
32.3%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With a Clinically Significant Infection — 12; 14; 5 Participants
Summary
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.
Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Clinically Significant Infection |
12; 14; 5 | — |
| SECONDARY Median Time to Neutrophil Engraftment |
24 | — |
| SECONDARY Median Time to Platelet Engraftment |
52 | — |
| SECONDARY Number of Participants With Primary Graft Failure |
8 | — |
| SECONDARY Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days |
16 | — |
| SECONDARY The Rate of Chronic GVHD |
21 | — |
| SECONDARY 100-day Treatment Related Mortality |
9.7 | — |
| SECONDARY Immune Reconstitution - Median CD4 Count at 12 Months |
362.4 | — |
| SECONDARY Relapse-free Survival |
49 | — |
| SECONDARY Overall Survival |
55 | — |
| SECONDARY 1 Year Relapse Rate |
20 | — |
| SECONDARY Rate of Post-transplant Lymphoma |
— | — |
| SECONDARY Median Thrombopoietin Levels After Transplant |
2500 | — |
Eligibility Criteria
Inclusion Criteria
- Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
- Appropriate candidate for reduced intensity regimen, according to the treating physician
- Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
- Able to comply with the requirements for care after allogeneic stem cell transplantation
Exclusion Criteria
- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
- Renal disease
- Hepatic disease
- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV-positive
- Uncontrolled infection
- Pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01408563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.