Phase 2
N=73
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Aggressive Non-Hodgkin Lymphoma · Chronic Myelogenous Leukemia · Chronic Phase Chronic Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00723099 ↗Enrolled (actual)
73
Serious AEs
25.0%
Results posted
Oct 2019
Primary outcome: Primary: Overall Survival — 35 percent of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation (Procedure); Cyclophosphamide (Drug); Cyclosporine (Drug); Fludarabine Phosphate (Drug); Laboratory Biomarker Analysis (Other); Mycophenolate Mofetil (Drug); Total-Body Irradiation (Radiation); Umbilical Cord Blood Transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
35 | — |
| SECONDARY Median Time to ANC > 500 |
18 | — |
| SECONDARY Number of Participants With Graft Failure/Rejection |
3 | — |
| SECONDARY Time to Platelet Engraftment of > 20,000 Cells Per mm3 |
46 | — |
| SECONDARY Percent of Patients With Grade II-IV Acute Graft Versus Host Disease |
67 | — |
| SECONDARY Percent of Patients With Acute GVHD Grades III-IV |
12 | — |
| SECONDARY Percent of Patients With Chronic GVHD |
19 | — |
| SECONDARY Percent of Patients With Non-relapse Mortality |
38 | — |
| SECONDARY Percent of Patients With Non-relapse Mortality |
38 | — |
Summary
This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
Eligibility Criteria
Inclusion Criteria
- Patients > 70 may be considered if performance status > 80% or Eastern Cooperative Oncology Group (ECOG) = = 35% or
- Fractional shortening > 22%
- Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements
- Adequate hepatic function; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
- Adequate renal function defined as creatinine = 40 ml/min (pediatrics)
- All adults with a creatinine > 1.2 or a history of renal dysfunction must have estimated creatinine clearance > 40 ml/min
- Performance status score: Karnofsky (for adults) >= 60 or ECOG 0-2; Lansky (for children) score >= 50
- If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease
- Second hematopoietic cell transplant: Must be >= 3 months after prior myeloablative transplant
- Patients who have received 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with the approval of the PI or designee
- Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors; at time of transplant, patients must have 25% of normal cellularity for age) by morphology within the bone marrow
- Myelodysplastic syndrome (MDS): Any subtype; morphologic blasts must be less than 5% in an evaluable marrow (> 25% of normal cellularity for age); if blasts are 5% or more, patient requires induction chemotherapy pre-transplant to reduce blast count to less than 5%; patients who have a hypocellular marrow in the absence of excess blasts that is related to the underlying disease or as a result of treatment for MDS may also be eligible with the approval of the PI or designee
- Large-cell lymphoma and aggressive T-cell lymphoma: With chemotherapy sensitive disease that has failed autologous transplant or patients who are ineligible for an autologous transplant; chemotherapy sensitive disease is defined as >= 50% reduction in the size of the tumor with the chemotherapy regimen immediately preceding transplant
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory to fludarabine (fludarabine phosphate) or fail to have a complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. cladribine [2-CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog)
- Hodgkin disease: Must have received and failed frontline therapy
- Follicular lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, and indolent T-cell lymphomas: Must have progressed with the most recent remission duration being = 2.5 x 10^7/kg
- Match grade 5/6 or 4/6; TNC dose >= 4.0 (+/- 0.5) x 10^7/kg
- If two CB units are used, the total cell dose of the combined units must be at least 3.0 x 10^7 TNC per kilogram recipient weight based on pre-cryopreservation numbers, with each CB unit containing a MINIMUM of 1.5 x 10^7 TNC/kg
- The minimum recommended CD34/kg cell dose s
Data sourced from ClinicalTrials.gov (NCT00723099). 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.