Clinical trial · Interventional
Cellular Therapy With Cord Blood Cells
Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NCT00427557CI-TRIAL-00006999completedPhase 2Results 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 goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.
Conditions
Conditions (3)
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 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Peripheral Blood Stem Cell Infusion | Other | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Umbilical Cord Blood | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cellular Therapy with Cord Blood Cells
- description
- Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
- interventionNames
- Drug: Fludarabine
- Drug: Melphalan
- Procedure: Umbilical Cord Blood
- Drug: Rituximab
- Other: Peripheral Blood Stem Cell Infusion
Primary outcomes (1)
- measure
- Number of Participants With Engraftment
- timeFrame
- Baseline to 100 days post-engraftment
- description
- Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L; assessed from baseline to 100 days post-engraftment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with multiple myeloma (MM), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HL), or chronic lymphocytic leukemia (CLL) in greater than first complete remission who are candidates for a non-ablative or reduced intensity conditioning regimen. 2. Age up to 80 years. 3. A related or unrelated donor who is HLA-matched at HLA, A, B, C, DR and DQ loci is acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the BMT program). Donor must be willing to donate peripheral blood or bone marrow progenitor cells. 4. Available cord blood unit must contain a minimum of 1.5 \* 10\^7 total nucleated cells per kg, and be at least a 4/6 HLA match with patient. 5. Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%. 6. Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic heart disease. 7. Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion Capacity (DLCO) \>40%. 8. Serum creatinine \<2.0 mg/dL. Serum bilirubin \<3 \* upper limit of normal, SGPT \<4 \* upper limit of normal. Exclusion Criteria: 1. Patients with active CNS disease 2. Positive Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 3. Serious medical or psychiatric illness likely to interfere with participation in this clinical study, including but not limited to active uncontrolled infection, uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major depression, or mania. 4. Evidence of chronic, active hepatitis or cirrhosis, or HIV
References
Publications (0)
Data not yet available
No reference posted for this study.