Clinical trial · Interventional
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders
NCT00801931CI-TRIAL-00037826terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant, and to quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant and non-malignant disorders.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Immunodeficiencies | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Horse Antithymocyte Globulin | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Phenytoin | Drug | — | UNRESOLVED |
| Rabbit Antithymocyte Globulin | Drug | — | UNRESOLVED |
| Thiotepa |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- A: Full Intensity with TBI
- description
- Patients will start their pre-conditioning regimen on Day -8. Fractionated total body irradiation (TBI) will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5 and-4, Cyclophosphamide on Days -3 and -2 and- rabbit antithymocyte globulin on Days -4, -3, -2 and -1.The double cord blood infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/mycophenolate mofetil (MMF).
- interventionNames
- Radiation: Total Body Irradiation
- Drug: Cyclophosphamide
- Drug: Rabbit Antithymocyte Globulin
- Drug: Thiotepa
- type
- EXPERIMENTAL
- label
- B: Full intensity without TBI
- description
- Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with double cord blood infusion on Day 0. Granulocyte-macrophage colony-stimulating factor (GM-CSF) hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Patients will be eligible for double cord blood stem cell transplant (TNC ≥ 4x107/kg of two combined units) if available single cord blood has TNC ≤4.0 x 107/kg and they lack a matched (5-6/6) family donor, a 10/10 unrelated adult donor, and/or if their disease status required emergent stem cell transplant and they could not wait 2-3 months for searching for a matched unrelated adult donor. * Adequate renal function defined as:Serum creatinine \<1.5 x normal, or Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>60 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range. * Adequate liver function defined as:Total bilirubin \<1.5 x normal, or serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase (ALT)) \<3.0 x normal * Adequate cardiac function defined as:Shortening fraction \>27% by echocardiogram, or Ejection fraction \>47% by radionucleotide angiogram or echocardiogram. * Adequate pulmonary function defined as:Uncorrected diffusing capacity of the lungs for carbon monoxide (DLCO) 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air. Eligibility for Moderate Intensity, Reduced Intensity Regimen and Fanconi's Anemia (Regimens C, D and E) * Adequate renal function defined as: Serum creatinine \<2.0 x normal, or Creatinine clearance or radioisotope GFR 40 ml/min/m2 or \>40 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range. * Adequate liver function defined as:Total bilirubin \<2.5 x normal, or SGOT (AST) or SGPT (ALT) \<5.0 x normal * Adequate cardiac function defined as:Shortening fraction of \>25% by echocardiogram, or Ejection fraction \>40% by radionucleotide angiogram or echocardiogram. * Adequate pulmonary function defined as:Uncorrected DLCO \>35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air. Exclusion Criteria: * Females who are pregnant or breast-feeding * Patients with documented uncontrolled infection at the time of study entry
References
Publications (0)
Data not yet available
No reference posted for this study.