N/A
Completed N=87
Combined Haploidentical-Cord Blood Transplantation for Adults and Children
Source: ClinicalTrials.gov NCT00943800 ↗Enrolled (actual)
87
Serious AEs
27.6%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants With Neutrophil Engraftment — 85.1 percentage of patients
Summary
The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Neutrophil Engraftment |
85.1 | — |
| SECONDARY Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) |
16.1; 3.4 | — |
| SECONDARY Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years |
43.7; 32.9 | — |
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.
- Relapsed or refractory acute leukemia (myeloid or lymphoid)
- Acute leukemia in first remission at high-risk for recurrence
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- Multiple myeloma
- Myelodysplastic syndrome
- Chronic myeloproliferative disease
- Hemoglobinopathies
- Aplastic anemia
Exclusion Criteria
- Zubrod performance status > 2
- Life expectancy is severely limited by concomitant illness
- Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
- Estimated Creatinine Clearance 2.0 mg/dl or SGPT >3 x upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
- HIV-positive
- Patient is pregnant
- Patient or guardian not able to sign informed consent
Data sourced from ClinicalTrials.gov (NCT00943800). 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.