TriangleNCT01408563 · REGISTRY CONDITION SEARCH
Reduced Intensity Double Umbilical Cord Blood Transplantation
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2019-01-23
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With a Clinically Significant Infection
Median Time to Neutrophil Engraftment
Median Time to Platelet Engraftment
Number of Participants With Primary Graft Failure
Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
The Rate of Chronic GVHD
100-day Treatment Related Mortality
Immune Reconstitution - Median CD4 Count at 12 Months
Relapse-free Survival
Overall Survival
1 Year Relapse Rate
Rate of Post-transplant Lymphoma
Median Thrombopoietin Levels After Transplant
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate * Appropriate candidate for reduced intensity regimen, according to the treating physician * Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant * Able to comply with the requirements for care after allogeneic stem cell transplantation Exclusion Criteria: * Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction * Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease * Renal disease * Hepatic disease * Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation * HIV-positive * Uncontrolled infection * Pregnant or breast-feeding
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- All patients receive same therapy
- intervention Names
- Drug: Fludarabine
- Drug: Melphalan
- Radiation: Total Body Radiation
- Biological: Cord Blood
- label
- Fludarabine/Melphalan/TBI
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Fludarabine/Melphalan/TBI
- description
- 30 mg/m2/day IV x 6 days
- name
- Fludarabine
- other Names
- Fludara
- type
- DRUG
- arm Group Labels
- Fludarabine/Melphalan/TBI
- description
- 100 mg/m2/day IV x 1 day
- name
- Melphalan
- type
- DRUG
- arm Group Labels
- Fludarabine/Melphalan/TBI
- description
- 200 cGy on Day 0
- name
- Total Body Radiation
- type
- RADIATION
- arm Group Labels
- Fludarabine/Melphalan/TBI
- description
- 2 cord blood units IV
- name
- Cord Blood
- type
- BIOLOGICAL
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 33
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
- measure
- Number of Participants With a Clinically Significant Infection
- time Frame
- 1 Year
- secondary Outcomes
- description
- The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment. neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count \> 500 neutrophils per microliter of blood.
- measure
- Median Time to Neutrophil Engraftment
- time Frame
- From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
- description
- The time to platelet engraftment is measured from the time of transplantation until the time of first documented platelet engraftment. Platelet engraftment is defined as a platelet count ≥ 20,000/µL for three consecutive measurements over three or more days. The first of the three days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 3 days or in the following 7 days after the day of engraftment, unless the platelet transfusion is being given specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal.
- measure
- Median Time to Platelet Engraftment
- time Frame
- From the time of transplantation, until the time of platelet engraftment, median duration of 52 days
- description
- Primary graft failure is defined as the failure to achieve an absolute neutrophil count (ANC) \>500/ µL by day 42, in the absence of relapse.
- measure
- Number of Participants With Primary Graft Failure
- time Frame
- From the time of transplantation until 42 days post transplantation
- description
- Acute GVHD is assessed using Consensus Criteria: Organ Classifications: * 0: No rash due to GVHD; Bilirubin \< 2 mg/dL; \< 500 mL diarrhea/ day * 1: Maculopapular rash \< 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum * 2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day * 3: Maculopapular rash \> 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day * 4: Generalized erythroderma with bullous formation; Bilirubin \> 15 mg/dL; Severe abdominal pain with or without ileus Overall Clinical Grade: * 0: No Stage 1-4 of any organ * I: Stage 1-2 rash and no liver or gut involvement * II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement * III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement * IV: Stage 4 skin rash, or Stage 4 liver involvement
- measure
- Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
- time Frame
- 100 Days
- description
- Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.
- measure
- The Rate of Chronic GVHD
- time Frame
- From the time of transplantation until the time of chronic GVHD onset, up to 1 year
- description
- The percentage of treatment related participant deaths within 100 days of receiving umbilical cord blood transplantation. All deaths in the absence of relapse of the primary malignancy will be considered treatment related mortality.
- measure
- 100-day Treatment Related Mortality
- time Frame
- 100 Days
- measure
- Immune Reconstitution - Median CD4 Count at 12 Months
- time Frame
- 1 Year
- description
- The percentage of participants that have not died or had disease progression by two years. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
- measure
- Relapse-free Survival
- time Frame
- 2 years
- description
- The percentage of participants alive at two years
- measure
- Overall Survival
- time Frame
- 2 years
- description
- The percentage of participants that relapsed within 12 months. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
- measure
- 1 Year Relapse Rate
- time Frame
- 1 year
- description
- The number of participants that were found to have lymphoma post-transplant.
- measure
- Rate of Post-transplant Lymphoma
- time Frame
- 2.5 years
- measure
- Median Thrombopoietin Levels After Transplant
- time Frame
- 30 Days
Full study description
- brief Summary
- This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
- detailed Description
- Subjects will receive their transplants as in-patients. * IV-Catheter * one or two IV catheters will be placed on the day of hospital admission * Conditioning * Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2) * Melphalan IV (day -1) * Total body radiation on day 0 (same day as transplant) * Immunosuppressive Therapy * Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient * Infusion of Cord Blood units * 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice