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Hematopoietic Stem Cell Transplantation
allogeneic hematopoietic stem cell transplantation for Leukemia
N/A
Waitlist Available
Led By Joseph Rosenthal, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed hematological or lymphatic malignancy
Patients with specific types of leukemia in certain remission stages or with poor risk factors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from transplant up to day 180 post-transplant
Awards & highlights
Study Summary
This trial is studying four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant to see how well they work in treating patients with relapsed or refractory hematologic cancer.
Who is the study for?
This trial is for patients with advanced blood cancers like leukemia, lymphoma, and myelodysplastic syndrome who have recovered from previous intense chemotherapy. They must have specific genetic markers or be in a certain phase of their disease to qualify. Participants need functioning major organs, no HIV or active infections, and must not be pregnant.Check my eligibility
What is being tested?
The study tests how well four different chemo regimens work with or without total-body irradiation before an umbilical cord blood transplant. The goal is to see if these treatments can help the patient's bone marrow recover and produce healthy cells while preventing immune rejection.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion of stem cells, organ inflammation due to immune response against normal cells, increased risk of infection from immunosuppressants like cyclosporine and mycophenolate mofetil, as well as typical chemo-related issues such as nausea, fatigue, hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer affects my blood or lymphatic system.
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My leukemia is in remission or has poor risk factors.
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I have two partially matched cord blood units available for my treatment.
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My condition is a relapse of myelodysplastic syndromes or non-Hodgkin lymphoma with bone marrow involvement.
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I have chronic lymphocytic leukemia that hasn't responded to treatment and can't undergo high-dose chemotherapy due to other health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from transplant up to day 180 post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from transplant up to day 180 post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Secondary outcome measures
Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Regimen IV (Fludarabine, Melphalan)Experimental Treatment7 Interventions
Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
Group II: Regimen III (TBI, Cyclophosphamide, Fludarabine)Experimental Treatment8 Interventions
Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
Group III: Regimen II (Busulfan, Fludarabine, Melphalan)Experimental Treatment8 Interventions
Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
Group IV: Regimen I (FTBI, Cyclophosphamide, Fludarabine)Experimental Treatment8 Interventions
Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine phosphate
2007
Completed Phase 2
~360
Busulfan
2008
Completed Phase 3
~1120
Filgrastim
FDA approved
Cyclophosphamide
1995
Completed Phase 3
~3770
Cyclosporine
1997
Completed Phase 3
~1830
Melphalan
2008
Completed Phase 3
~1500
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
total-body irradiation
2000
Completed Phase 3
~1250
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
umbilical cord blood transplantation
2008
Completed Phase 3
~1120
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,606 Total Patients Enrolled
82 Trials studying Leukemia
4,974 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,353 Total Patients Enrolled
1,515 Trials studying Leukemia
384,569 Patients Enrolled for Leukemia
Joseph Rosenthal, MDPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
4 Previous Clinical Trials
96 Total Patients Enrolled
2 Trials studying Leukemia
81 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am still recovering from intense chemotherapy.My cancer affects my blood or lymphatic system.My leukemia is in remission or has poor risk factors.My heart, lungs, and kidneys meet the specific health criteria required.I have a history of cancer.I haven't had cancer in the last 5 years, except for skin cancer.I have two partially matched cord blood units available for my treatment.I don't have a fully matched family or unrelated bone marrow donor.I am infected with HIV-1.I have an ongoing infection that is not under control.My condition is a relapse of myelodysplastic syndromes or non-Hodgkin lymphoma with bone marrow involvement.I have chronic lymphocytic leukemia that hasn't responded to treatment and can't undergo high-dose chemotherapy due to other health issues.I have had a condition where lymphocytes are produced in excessive amounts.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen I (FTBI, Cyclophosphamide, Fludarabine)
- Group 2: Regimen II (Busulfan, Fludarabine, Melphalan)
- Group 3: Regimen III (TBI, Cyclophosphamide, Fludarabine)
- Group 4: Regimen IV (Fludarabine, Melphalan)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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