Phase 2
N=30
Cellular Therapy With Cord Blood Cells
Multiple Myeloma · Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00427557 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
May 2012
Primary outcome: Primary: Number of Participants With Engraftment — 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Melphalan (Drug); Umbilical Cord Blood (Procedure); Rituximab (Drug); Peripheral Blood Stem Cell Infusion (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Engraftment |
27 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Age up to 80 years.
- 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.
- 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.
- Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.
- Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic heart disease.
- Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion Capacity (DLCO) >40%.
- Serum creatinine <2.0 mg/dL. Serum bilirubin <3 * upper limit of normal, SGPT <4 * upper limit of normal.
Exclusion Criteria
- Patients with active CNS disease
- Positive Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- 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.
- Evidence of chronic, active hepatitis or cirrhosis, or HIV
Data sourced from ClinicalTrials.gov (NCT00427557). 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.