Clinical trial · Interventional
Combined Haploidentical-Cord Blood Transplantation for Adults and Children
NCT00943800CI-TRIAL-00049648completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine, Busulfan, and ATG | Drug | — | UNRESOLVED |
| Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG) | Drug | — | UNRESOLVED |
| Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI) | Drug | — | UNRESOLVED |
| Stem Cells Collections | Procedure | — | UNRESOLVED |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Good Risks patients
- description
- For patients transplanted in remission.
- interventionNames
- Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
- Procedure: Stem Cell Transplant
- Procedure: Stem Cells Collections
- type
- EXPERIMENTAL
- label
- High Risk Patients eligible for radiation
- interventionNames
- Procedure: Stem Cell Transplant
- Procedure: Stem Cells Collections
- Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
- type
- EXPERIMENTAL
- label
- High Risk Patients not eligible for radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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. 1. Relapsed or refractory acute leukemia (myeloid or lymphoid) 2. Acute leukemia in first remission at high-risk for recurrence 3. Chronic myelogenous leukemia in accelerated phase or blast-crisis 4. Chronic myelogenous leukemia in chronic phase 5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma 6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features 7. Multiple myeloma 8. Myelodysplastic syndrome 9. Chronic myeloproliferative disease 10. Hemoglobinopathies 11. Aplastic anemia Exclusion Criteria: 1. Zubrod performance status \> 2 2. Life expectancy is severely limited by concomitant illness 3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's) 4. Estimated Creatinine Clearance \<50 ml/min 5. Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal 6. Evidence of chronic active hepatitis or cirrhosis 7. HIV-positive 8. Patient is pregnant 9. Patient or guardian not able to sign informed consent
References
Publications (2)
- RESULTLiu H, Rich ES, Godley L, Odenike O, Joseph L, Marino S, Kline J, Nguyen V, Cunningham J, Larson RA, del Cerro P, Schroeder L, Pape L, Stock W, Wickrema A, Artz AS, van Besien K. Reduced-intensity conditioning with combined haploidentical and cord blood transplantation results in rapid engraftment, low GVHD, and durable remissions. Blood. 2011 Dec 8;118(24):6438-45. doi: 10.1182/blood-2011-08-372508. Epub 2011 Oct 5. PMID 21976674
- DERIVEDvan Besien K, Hari P, Zhang MJ, Liu HT, Stock W, Godley L, Odenike O, Larson R, Bishop M, Wickrema A, Gergis U, Mayer S, Shore T, Tsai S, Rhodes J, Cushing MM, Korman S, Artz A. Reduced intensity haplo plus single cord transplant compared to double cord transplant: improved engraftment and graft-versus-host disease-free, relapse-free survival. Haematologica. 2016 May;101(5):634-43. doi: 10.3324/haematol.2015.138594. Epub 2016 Feb 11. PMID 26869630