Clinical trial · Interventional
Unrelated Double Umbilical Cord Blood Units Transplantation
Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
NCT01015742CI-TRIAL-00007051unknownPhase 2 / Phase 3ClinicalTrials.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 purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stem cell Transplantation | Drug | Hematopoietic Cell Transplantation | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Stem cell Transplant using two unrelated umbilical cord blood units.
- interventionNames
- Drug: Stem cell Transplantation
Primary outcomes (1)
- measure
- To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
- timeFrame
- Until end of study
Secondary outcomes (4)
- measure
- Neutrophil and platelet engraftment
- timeFrame
- 1 year
- measure
- Severity of acute graft-vs-host disease(GvHD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Hematologically \& Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission * Aged 1 year to 50 years * Absence of HLA compatible related or other related donor. * Availability of suitable UCB units. * karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) : 80- 100 * Adequate renal function defined as:Serum creatinine \<1.5 x normal, * Adequate liver function defined as:Total bilirubin \<1.5 x normal, or SGOT (AST) or SGPT (ALT) \<3.0 x normal * Adequate cardiac function defined as: Ejection fraction \>50% by echocardiogram. * Adequate pulmonary function defined as:Uncorrected 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 Exclusion Criteria: * Age: \< 1year or \> 50 year * Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor * karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) \< 80 * HIV positive patients. * Female patients who are pregnant or breast feeding * Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant * Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection * Serious psychiatric/ psychological disorders * Absence of /inability to provide informed consent * Clinical or Paraclinical evidence of CNS or PNS involvement
References
Publications (0)
Data not yet available
No reference posted for this study.