Phase 2
N=105
Randomized Double Cord Blood Transplant Study
Leukemia, Lymphocytic, Acute · Leukemia, Myelocytic, Acute · Leukemia, Myeloid, Chronic · Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00067002 ↗Enrolled (actual)
105
Serious AEs
12.4%
Results posted
May 2019
Primary outcome: Primary: Time To Neutrophil Engraftment — 17; 15 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Expanded allogeneic cord blood (CB) (Procedure); One Unmanipulated and One Expanded Cord Blood Unit (Procedure); Rituxan (Drug); Melphalan (Drug); Thiotepa (Drug); Fludarabine (Drug); Cyclophosphamide (Drug); Mesna (Drug); Total body irradiation (TBI) (Radiation)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time To Neutrophil Engraftment |
17; 15 | — |
| PRIMARY Number of Participants With Engraftment |
45; 44 | — |
| SECONDARY Rate of Acute Graft Versus Host Disease (GVHD) |
29; 24 | — |
| SECONDARY Rate of Chronic GVHD |
16; 20; 10; 14; 9; 13 | — |
| SECONDARY Number of Participants Severity of Acute GVHD by Treatment Arm |
20; 15; 6; 2; 19; 27 | — |
Summary
The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.
Eligibility Criteria
Inclusion Criteria
- Disease-Specific Eligibility Requirements: Patients must have one of the following hematologic malignancies: 1. Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) 2. Acute Lymphoblastic Leukemia (ALL) 3. Chronic Myelogenous Leukemia (CML) 4. Non-Hodgkin's Lymphoma (NHL) 5. Hodgkin's Disease (HD) 6. Chronic Lymphocytic Leukemia (CLL) 7. Chronic eosinophilic leukemia or Philadelphia chromosome negative CML.
- Greater than 1 month old and = 12 years), or Lansky Play-Performance Scale (age =1 month = 12 years), or Lansky Play-Performance Scale (age = 1 month = 12 years), or Lansky Play-Performance Scale (age = 1 month <=50 years. 4. Organ function requirements: a. Left ventricular ejection function of at least 50%. b. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. c. Creatinine < 1.6 mg/dL. d. SGPT <= 2.0 x normal.
Exclusion Criteria
- HIV positive.
- Pregnancy.
- Serious medical Condition.
- Patients with signs & symptoms leading to positive lumbar puncture (malignant cells in the CSF) or to documented metastatic parenchymal disease are ineligible for this study.
- Availability of appropriate, willing, HLA-matched related donor.
Data sourced from ClinicalTrials.gov (NCT00067002). 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.