Acute LeukemiaNCT03016806
Umbilical Cord Blood Transplantation From Unrelated Donors
An observational study of Acute Leukemia and Immune Deficiency Disorder, run by University of Rochester at 1 site in United States.
Trial summary
This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Read more about this study
- Who is it for?
- Ages 2 months to 75 years
- Conditions the study is for
- Acute Leukemia, Immune Deficiency Disorder, Congenital Hematological Disorder
- What is being tested?
- Total Body Irradiation 1200 cGy, Total Body Irradiation 200 cGy and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:
- Congenital and Other Non-malignant Disorders:
- Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
- Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
- Metabolic disorders (e.g. Hurler's Syndrome)
- Severe aplastic anemia
Show all 38Show fewer
- High-Risk Leukemia:
- Acute Myelogenous Leukemia
- Refractory to standard induction therapy (more than 1 cycle required to achieve remission)
- Recurrent (in CR ≥ 2)
- Treatment-related AML or MDS
- Evolved from myelodysplastic syndrome
- Presence of FLT3 abnormalities
- FAB M6 or M7
- Adverse cytogenetics
- Myelodysplastic Syndrome
- Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:
- Refractory to standard induction therapy (time to CR >4 weeks)
- Recurrent (in CR ≥ 2)
- WBC count >30,000/mcL at diagnosis
- Age >30 at diagnosis
- Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.
- Chronic Myelogenous Leukemia in accelerated phase or blast crisis
- Biphenotypic or undifferentiated leukemia
- Burkitt's leukemia or lymphoma
- Lymphoma:
- Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT
- Marginal zone or follicular lymphoma that is progressive after at least two prior therapies
- Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT
- Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status
- Adequate organ function:
- Cardiac - LVEF >45%, or shortening fraction >25%, Absence of congestive heart failure or conduction disturbances with high risk for sudden death
- Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;
- Renal - serum Cr < 1.5 times the upper limit of normal for age or GFR ≥ 50 ml/min/1.73m2
- Hepatic - total bilirubin level < 2 times the upper limit of normal (except for patients with Gilbert's syndrome or hemolysis); if the primary disease process is causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5 times upper limit of normal.
- Performance Status Karnofsky or Lansky score ≥ 70%.
- Informed Consent must be obtained prior to initiating conditioning therapy.
- Receipt of viable cord blood product(s), single or dual, must be confirmed with the stem cell processing laboratory prior to initiating conditioning therapy.
Who cannot join
- Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant
- Autologous HSCT < 6 months prior to proposed UCB transplant
- Pregnant or breast feeding
- Current uncontrolled infection
- Evidence of HIV infection or positive HIV serology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wilmot Cancer Institute
Rochester, New York, 14642
Omar Aljitawi, MD, 585-275-4099, omar_aljitawi@urmc.rochester.edu
About this study
This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals.
II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy.
III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts.
IV. Document the overall survival, disease-free-survival, and rates of relapse for UCB transplant recipients.
OUTLINE: This is an observational study.
Patients undergo a conditioning regimen per standard of care at the discretion of the treating provider, followed by a planned UCB transplantation on study. Patients also have their medical records reviewed for engraftment data on study.
- Conditions
- Acute Leukemia, Immune Deficiency Disorder, Congenital Hematological Disorder, Metabolism Disorder, Aplastic Anemia, Myelodysplastic Syndromes
- Being tested
- Total Body Irradiation 1200 cGy, Total Body Irradiation 200 cGy, Cyclophosphamide, Mesna, Cord Blood Infusion
- Medical subject headings
- Immunologic Deficiency Syndromes, Metabolic Diseases, Anemia, Aplastic, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Body Irradiation 1200 cGyRadiation
Also called TBI 1200 cGy
Total Body Irradiation 1200 cGy in 8 fractions
Total Body Irradiation 200 cGyRadiation
Also called TBI 200 cGy
Total Body Irradiation 200 cGy in one fraction
CyclophosphamideDrug
Also called Cy
50 mg/kg or 60 mg/kg
MesnaDrug
Also called Pre-Mesna
50 mg/kg or 60 mg/kg plus 10% loading dose
Cord Blood InfusionProcedure or surgery
Intravenous infusion of cord blood stem cells
BusulfanDrug
Also called Bu
0.8 mg/kg x 16 doses
FludarabineDrug
Also called Flu
30 mg/m2/day x 5 or 40 mg/m2/day x 5
MelphalanDrug
Also called Mel
140 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Full Intensity, TBI-based Conditioning | Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: TBI/Cy Receives: Radiation: Total Body Irradiation 1200 cGy; Drug: Cyclophosphamide; Drug: Mesna; Procedure: Cord Blood Infusion | |
| Full Intensity, Chemo-based Conditioning | Full Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients <5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients >/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: Bu/Cy Receives: Drug: Cyclophosphamide; Drug: Mesna; Procedure: Cord Blood Infusion; Drug: Busulfan | |
| Reduced Intensity Chemotherapy | Reduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel Receives: Procedure: Cord Blood Infusion; Drug: Fludarabine; Drug: Melphalan | |
| Non-Myeloablative Conditioning | Fludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose [to be completed 24 hours after Cyclophosphamide dose] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI Receives: Radiation: Total Body Irradiation 200 cGy; Drug: Cyclophosphamide; Drug: Mesna; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment of ANC and Platelets
The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.
Measured: 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]
Secondary outcomes (4)
Rate of non-engraftment and of secondary graft failure
The percentage of patients who fail to initially engraft ANC will be tabulated as well as the percentage of patients who have primary engraftment of ANC but whose graft fails as evidenced by pancytopenia, failure of bone marrow function and loss of donor chimerism following initial engraftment of ANC.
Measured: At 30 days, 100 days, 6 months and yearly from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Incidence of acute graft-versus-host disease
Routine physical exams, liver function tests, and clinical history of diarrhea and upper GI symptoms will be used to assess the presence of, the maximum severity of and the date of onset of Acute GvHD based on the criteria published by Przepioka et al., Bone Marrow Transplant 1995; 15(6):825-8 as used by the Center for International Blood \& Marrow Transplant Research. The percentage of patients developing symptoms of acute graft-versus-host disease will be tabulated.
Measured: At 30 days and 100 days after transplant from the date of transplant until the date of documented acute GvHD.
Incidence of chronic graft-versus-host disease
Assess the presence of and the maximum severity of and the date of onset of chronic GvHD based on Sullivan KM, Blood 1981;57-267 as used by the Cneter for International Blood \& Marrow Transplant Research.
Measured: At 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Disease-free survival
Document and update the length of time a subject survives without recurrence of the disease for which they were transplanted at 30 days, 100 days, 6 months and yearly following the infusion of cord blood stem cells for as long as the subjects survive and remain disease-free.
Measured: At 30 days, 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Aljitawi, University of Rochester
- Investigators
- Omar Aljitawi, MD, Principal investigator, Professor - Department of Medicine, Hematology/Oncology (SMD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016806
- Sponsor's protocol ID
- UBMT 15029
- Status last verified
- Oct 2025
- First submitted
- 26 Dec 2016
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Transplantation From Unrelated Donors
- ClinicalTrials.gov ID
- NCT03016806
- Acronym / sponsor ID
- UBMT 15029
- Conditions
- Acute Leukemia, Immune Deficiency Disorder, Congenital Hematological Disorder, Metabolism Disorder, Aplastic Anemia, Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).
Detailed description
PRIMARY OBJECTIVES:
- Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals.
II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy.
III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts.
IV. Document the overall survival, disease-free-survival, and rates of relapse for UCB transplant recipients.
OUTLINE: This is an observational study.
Patients undergo a conditioning regimen per standard of care at the discretion of the treating provider, followed by a planned UCB transplantation on study. Patients also have their medical records reviewed for engraftment data on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full Intensity, TBI-based Conditioning | – | Radiation: Total Body Irradiation 1200 cGy, Drug: Cyclophosphamide, Drug: Mesna, Procedure: Cord Blood InfusionFull Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: TBI/Cy |
| Full Intensity, Chemo-based Conditioning | – | Drug: Cyclophosphamide, Drug: Mesna, Procedure: Cord Blood Infusion, Drug: BusulfanFull Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients <5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients >/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses [to be completed 24 hours after final Cyclophosphamide dose] followed by Cord Blood Infusion Other names: Bu/Cy |
| Reduced Intensity Chemotherapy | – | Procedure: Cord Blood Infusion, Drug: Fludarabine, Drug: MelphalanReduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel |
| Non-Myeloablative Conditioning | – | Radiation: Total Body Irradiation 200 cGy, Drug: Cyclophosphamide, Drug: Mesna, Drug: FludarabineFludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose [to be completed 24 hours after Cyclophosphamide dose] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI |
Who may qualify
- Ages
- 2 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (38 listed)
- Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:
- Congenital and Other Non-malignant Disorders:
- Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
- Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
- Metabolic disorders (e.g. Hurler's Syndrome)
Key exclusion criteria (5 listed)
- Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant
- Autologous HSCT < 6 months prior to proposed UCB transplant
- Pregnant or breast feeding
- Current uncontrolled infection
- Evidence of HIV infection or positive HIV serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Body Irradiation 1200 cGyAlso: TBI 1200 cGyTotal Body Irradiation 1200 cGy in 8 fractions | Radiation | Full Intensity, TBI-based Conditioning |
| Total Body Irradiation 200 cGyAlso: TBI 200 cGyTotal Body Irradiation 200 cGy in one fraction | Radiation | Non-Myeloablative Conditioning |
| CyclophosphamideAlso: Cy50 mg/kg or 60 mg/kg | Drug | Full Intensity, Chemo-based Conditioning, Full Intensity, TBI-based Conditioning, Non-Myeloablative Conditioning |
| MesnaAlso: Pre-Mesna50 mg/kg or 60 mg/kg plus 10% loading dose | Drug | Full Intensity, Chemo-based Conditioning, Full Intensity, TBI-based Conditioning, Non-Myeloablative Conditioning |
| Cord Blood InfusionIntravenous infusion of cord blood stem cells | Procedure or surgery | Full Intensity, Chemo-based Conditioning, Full Intensity, TBI-based Conditioning, Reduced Intensity Chemotherapy |
| BusulfanAlso: Bu0.8 mg/kg x 16 doses | Drug | Full Intensity, Chemo-based Conditioning |
| FludarabineAlso: Flu30 mg/m2/day x 5 or 40 mg/m2/day x 5 | Drug | Non-Myeloablative Conditioning, Reduced Intensity Chemotherapy |
| MelphalanAlso: Mel140 mg/m2 | Drug | Reduced Intensity Chemotherapy |
Primary outcome
Engraftment of ANC and Platelets
Time frame: 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]
The date of engraftment of ANC is the first of 3 consecutive days of ANC of 500 or higher based on daily CBC and Differential Counts. The date of engraftment of platelets is the first of three consecutive days of platelet counts of 20,000 or higher in the absence of platelet transfusions for a t least 7 days prior.
4 secondary outcomes
Rate of non-engraftment and of secondary graft failure
Time frame: At 30 days, 100 days, 6 months and yearly from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Incidence of acute graft-versus-host disease
Time frame: At 30 days and 100 days after transplant from the date of transplant until the date of documented acute GvHD.
Incidence of chronic graft-versus-host disease
Time frame: At 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Disease-free survival
Time frame: At 30 days, 100 days, 6 months and yearly after transplant from the date of transplant until the date of documented graft failure or the subject's death up to 120 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar Aljitawi, MD principal investigator
Professor - Department of Medicine, Hematology/Oncology (SMD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Immune Deficiency Disorder, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Aljitawi, MD (585-275-4099, omar_aljitawi@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment of ANC and Platelets (time frame: 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.