Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2NCT00864227
Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)
A Phase 2 study testing Hematopoietic Umbilical Cord Blood Stem Cell Transplantation and GVHD prophylaxis in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Leukemia, Myeloid, Acute, run by Medical College of Wisconsin at 16 sites in United States.
Trial summary
A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma
- What is being tested?
- Hematopoietic Umbilical Cord Blood Stem Cell Transplantation and GVHD prophylaxis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2008to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be 21 to 70 years old; participants 1 to 21 years old are also eligible if they are ineligible for BMT CTN #0501 (NCT00412360)
- Each unit must supply a minimum of 1.5 x 10^7/kg pre-cryopreserved nucleated cell dose
- Participants must have two partially human leucocyte antigen (HLA)-matched umbilical cord blood units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0 to 2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. Each unit must be a 4 to 6 HLA-A, B, and DRB1 antigen matched to each other, not necessarily at the same loci as with the recipient. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 for this study. An adult unrelated donor search is not required for a person to be eligible for this study if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6 to 8 weeks from referral to transplant center or low likelihood of finding a matched, unrelated donor.
- Must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of chemotherapy)
- Acute leukemias (includes T lymphoblastic lymphoma) in the second or subsequent complete remission (CR)
- Burkitt's lymphoma in the second or subsequent CR
Show all 12Show fewer
- Lymphoma
- Patients with adequate physical function, as measured by the following:
- Heart: left ventricular ejection fraction at rest greater than 35%, or shortening fraction greater than 25%
- Liver: bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than or equal to five times the upper limit of normal
- Kidney: serum creatinine within normal range for age, or if serum creatinine is outside the normal range for age, then kidney function (creatinine clearance or glomerular filtration rate (GFR) greater than 40 mL/min/1.73m^2
- Lungs: forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusing capacity (DLCO) greater than 50% predicted (corrected for hemoglobin). If unable to perform pulmonary function tests, then oxygen (O2) saturation must be greater than 92% on room air.
Who cannot join
- Have an HLA-matched, related, or 7 or 8/8 HLA allele matched (HLA-A, -B, -Cw, -DRB1) related donor able to donate
- Had an autologous hematopoietic stem cell transplant in the 3 months before study entry
- Pregnant or breastfeeding
- Evidence of HIV infection or known HIV positive serology
- Current uncontrolled bacterial, viral, or fungal infection (i.e., currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
- Prior allogeneic hematopoietic stem cell transplant
- History of primary idiopathic myelofibrosis
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Dana-Farber Cancer Institute (DFCI), Brigham & Women's Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute (DFCI), Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio State, Arthur G. James Cancer Hospital
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010
University of Florida College of Medicine, Shands
Gainesville, Florida, 32610-3633
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
University of Kansas Hospital
Kansas City, Kansas, 66160
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-5156
University of Minnesota
Minneapolis, Minnesota, 55455
Weill Cornell Medical College, NY Presbyterian Hospital
New York, New York, 10065
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University, Medical College of Virginia (MCV) Hospital
Richmond, Virginia, 23298
Texas Transplant Institute
San Antonio, Texas, 78229
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624
About this study
Official title: A Multi-Center, Phase II Trial of Non-Myeloablative Conditioning (NST) and Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies (BMT CTN #0604)
A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.
Read the detailed description
Leukemia and lymphoma are types of blood cancers. Chemotherapy is a common treatment option for people with these types of cancers, but if the cancer does not respond well to chemotherapy, or if the cancer returns, people may need to consider other options. A bone marrow transplant, which is a type of stem cell transplant in which healthy bone marrow is donated to a patient by a related or unrelated donor, is commonly used to treat leukemia and lymphoma. Recently, stem cell transplants using umbilical cord blood have become a viable option to treat these types of cancers. Traditionally, umbilical cord blood, which is the blood left over in the placenta after a baby is born, has been disposed of with the placenta. However, over the past few years, doctors have begun to collect and freeze the umbilical cord blood cells so that they may be used in stem cell transplant procedures at a later time.
Typically, people who are undergoing a stem cell transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor stem cells. In this study, participants will undergo a new type of stem cell transplant called a nonmyeloablative transplant, which is a reduced intensity method of transplantation that does not require high doses of chemotherapy. The purpose of the study is to examine the safety and effectiveness of a nonmyeloablative stem cell transplant that uses umbilical cord blood as a treatment option for people with leukemia or lymphoma.
This study will enroll people with leukemia or lymphoma. Participants will be admitted to the hospital and will first receive a type of chemotherapy called cyclophosphamide, which will be given intravenously on the sixth day before the transplant. In addition, another type of chemotherapy, fludarabine, will be given intravenously each day for 5 days before the transplant. Three days before the transplant, participants will receive cyclosporine and mycophenolate mofetil (MMF), to help prevent the body from rejecting the stem cells and to help decrease the risk of developing a complication called graft-versus-host-disease (GVHD), which is an attack by the donor cells on the body's normal tissues. Some participants may receive tacrolimus instead of cyclosporine. After 6 days, participants will receive a small dose of radiation. The next day, participants will undergo the umbilical cord blood stem cell transplant.
Participants will remain in the hospital for approximately 2 to 3 months total, but possibly longer if there are complications. Beginning on the first day after the transplant, participants will receive daily injections of a growth factor called granulocyte-colony stimulating factor (G-CSF), which is a natural protein that increases the white blood cell count; G-CSF will be continued until a participant's white blood cell count is normal again. Participants will continue to receive MMF for 30 days and cyclosporine or tacrolimus for 180 days after the transplant. While participants are in the hospital, blood samples will be collected regularly to evaluate the response and possible side effects to treatment, including GVHD. If necessary, participants will receive platelet and red blood cell transfusions. At follow-up study visits 6 months and 1 year after the transplant, blood samples will be obtained. Study researchers will keep track of participants' medical condition through phone calls or mailings to participants and their doctors once a year for the rest of the participants' lives.
- Conditions
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
- Being tested
- Hematopoietic Umbilical Cord Blood Stem Cell Transplantation, GVHD prophylaxis
- Keywords
- Acute Lymphoblastic Leukemia/Lymphoma, Acute Myelogenous Leukemia, Mantel-Cell Lymphoma, Hematopoietic Transplant, Umbilical Cord Blood (UCB), Non-Myeloablative Transplant
- Medical subject headings
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Umbilical Cord Blood Stem Cell TransplantationBiological
The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
- Fludarabine: 40 mg/m^2 intravenously (IV) on Days -6, -5, -4, -3, and -2
- Cyclophosphamide: 50 mg/kg IV on Day -6
- Total body irradiation: 200 centigray (cGy) on Day -1
GVHD prophylaxisBiological
GVHD prophylaxis regimen will consist of:
- Cyclosporine: beginning on Day -3 with the dose adjusted to maintain a level of 200-400 mg/mL
- MMF: 1 gram IV three times a day (TID) if greater than 50 kg, or 15 mg/kg IV TID if less than 50 kg beginning on Day -3; continued until Day 30 or 7 days after engraftment, whichever day is later
Day 0 is the day of the infusion of the umbilical cord blood graft units, which will be obtained from partially HLA-matched unrelated donors.
Beginning on Day 1, participants will receive G-CSF 5 mcg/kg/day until absolute neutrophil count (ANC) is greater than or equal to 2,000/mm^3 for three consecutive measurements, each on different days.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood Transplantation | Experimental | Participants will receive a double unit Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen, GVHD prophylaxis. Receives: Biological: Hematopoietic Umbilical Cord Blood Stem Cell Transplantation; Biological: GVHD prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 180 Days From the Time of Transplant
Measured: Measured at Month 6 and Year 1
Secondary outcomes (11)
Neutrophil Recovery
Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.
Measured: Measured at Days 28, 56, 90, and 100
Primary Graft Failure
Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.
Measured: Measured at Day 100
Secondary Graft Failure
Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.
Measured: Measured at Day 100
Platelet Recovery to 20K
Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.
Measured: Measured at Days 56, 90, and 100
Donor Cell Engraftment
Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.
Measured: Measured at Day 56
Acute Graft-versus-host Disease (GVHD)
Measured: Measured at Day 100
Chronic GVHD
Measured: Measured at Year 1
Progression-free Survival
Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.
Measured: Measured at Year 1
Treatment-related Mortality (TRM)
Measured: Measured at 6 months and 1 year
Incidence of Infections
Number of participants that experienced at least one infection.
Measured: Measured at Year 1
Platelet Recovery to 50K
Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.
Measured: Measured at Days 56, 90, and 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Precursor B-Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Mary Horowitz, MD, MS, Study director, Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864227
- Sponsor's protocol ID
- BMTCTN0604
- Other IDs
- U01HL069294, 5U24CA076518
- Status last verified
- Dec 2022
- First submitted
- 17 Mar 2009
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Findings will be published in a manuscript.
Publications
Brunstein CG, Fuchs EJ, Carter SL, Karanes C, Costa LJ, Wu J, Devine SM, Wingard JR, Aljitawi OS, Cutler CS, Jagasia MH, Ballen KK, Eapen M, O'Donnell PV; Blood and Marrow Transplant Clinical Trials Network. Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood. 2011 Jul 14;118(2):282-8. doi: 10.1182/blood-2011-03-344853. Epub 2011 Apr 28.
PubMed 21527516Eapen M, O'Donnell P, Brunstein CG, Wu J, Barowski K, Mendizabal A, Fuchs EJ. Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Oct;20(10):1485-92. doi: 10.1016/j.bbmt.2014.05.015. Epub 2014 May 23.
PubMed 24862638
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase II Trial of Non-Myeloablative Conditioning (NST) and Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies (BMT CTN #0604)
- ClinicalTrials.gov ID
- NCT00864227
- Acronym / sponsor ID
- BMTCTN0604
- Conditions
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
- Keywords
- Acute Lymphoblastic Leukemia/Lymphoma, Acute Myelogenous Leukemia, Mantel-Cell Lymphoma, Hematopoietic Transplant, Umbilical Cord Blood (UCB), Non-Myeloablative Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Posted 28 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.
Detailed description
Leukemia and lymphoma are types of blood cancers. Chemotherapy is a common treatment option for people with these types of cancers, but if the cancer does not respond well to chemotherapy, or if the cancer returns, people may need to consider other options. A bone marrow transplant, which is a type of stem cell transplant in which healthy bone marrow is donated to a patient by a related or unrelated donor, is commonly used to treat leukemia and lymphoma. Recently, stem cell transplants using umbilical cord blood have become a viable option to treat these types of cancers. Traditionally, umbilical cord blood, which is the blood left over in the placenta after a baby is born, has been disposed of with the placenta. However, over the past few years, doctors have begun to collect and freeze the umbilical cord blood cells so that they may be used in stem cell transplant procedures at a later time.
Typically, people who are undergoing a stem cell transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor stem cells. In this study, participants will undergo a new type of stem cell transplant called a nonmyeloablative transplant, which is a reduced intensity method of transplantation that does not require high doses of chemotherapy. The purpose of the study is to examine the safety and effectiveness of a nonmyeloablative stem cell transplant that uses umbilical cord blood as a treatment option for people with leukemia or lymphoma.
This study will enroll people with leukemia or lymphoma. Participants will be admitted to the hospital and will first receive a type of chemotherapy called cyclophosphamide, which will be given intravenously on the sixth day before the transplant. In addition, another type of chemotherapy, fludarabine, will be given intravenously each day for 5 days before the transplant. Three days before the transplant, participants will receive cyclosporine and mycophenolate mofetil (MMF), to help prevent the body from rejecting the stem cells and to help decrease the risk of developing a complication called graft-versus-host-disease (GVHD), which is an attack by the donor cells on the body's normal tissues. Some participants may receive tacrolimus instead of cyclosporine. After 6 days, participants will receive a small dose of radiation. The next day, participants will undergo the umbilical cord blood stem cell transplant.
Participants will remain in the hospital for approximately 2 to 3 months total, but possibly longer if there are complications. Beginning on the first day after the transplant, participants will receive daily injections of a growth factor called granulocyte-colony stimulating factor (G-CSF), which is a natural protein that increases the white blood cell count; G-CSF will be continued until a participant's white blood cell count is normal again. Participants will continue to receive MMF for 30 days and cyclosporine or tacrolimus for 180 days after the transplant. While participants are in the hospital, blood samples will be collected regularly to evaluate the response and possible side effects to treatment, including GVHD. If necessary, participants will receive platelet and red blood cell transfusions. At follow-up study visits 6 months and 1 year after the transplant, blood samples will be obtained. Study researchers will keep track of participants' medical condition through phone calls or mailings to participants and their doctors once a year for the rest of the participants' lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood Transplantation | Experimental | Biological: Hematopoietic Umbilical Cord Blood Stem Cell Transplantation, Biological: GVHD prophylaxisParticipants will receive a double unit Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen, GVHD prophylaxis. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must be 21 to 70 years old; participants 1 to 21 years old are also eligible if they are ineligible for BMT CTN #0501 (NCT00412360)
- Each unit must supply a minimum of 1.5 x 10^7/kg pre-cryopreserved nucleated cell dose
- Participants must have two partially human leucocyte antigen (HLA)-matched umbilical cord blood units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. This may include 0 to 2 antigen mismatches at each A or B (at the antigen level) or DRB1 (at the allele level) loci. Each unit must be a 4 to 6 HLA-A, B, and DRB1 antigen matched to each other, not necessarily at the same loci as with the recipient. All typing will be done using molecular typing. Though molecular level typing will be available, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1 for this study. An adult unrelated donor search is not required for a person to be eligible for this study if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6 to 8 weeks from referral to transplant center or low likelihood of finding a matched, unrelated donor.
- Must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of chemotherapy)
- Acute leukemias (includes T lymphoblastic lymphoma) in the second or subsequent complete remission (CR)
Key exclusion criteria (7 listed)
- Have an HLA-matched, related, or 7 or 8/8 HLA allele matched (HLA-A, -B, -Cw, -DRB1) related donor able to donate
- Had an autologous hematopoietic stem cell transplant in the 3 months before study entry
- Pregnant or breastfeeding
- Evidence of HIV infection or known HIV positive serology
- Current uncontrolled bacterial, viral, or fungal infection (i.e., currently taking medication with evidence of progression of clinical symptoms or radiologic findings)
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 |
|---|---|---|
| Hematopoietic Umbilical Cord Blood Stem Cell TransplantationThe transplant preparative regimen is listed below. The - sign is the number of days before the transplant. * Fludarabine: 40 mg/m^2 intravenously (IV) on Days -6, -5, -4, -3, and -2 * Cyclophosphamide: 50 mg/kg IV on Day -6 * Total body irradiation: 200 centigray (cGy) on Day -1 | Biological | Umbilical Cord Blood Transplantation |
| GVHD prophylaxisGVHD prophylaxis regimen will consist of: * Cyclosporine: beginning on Day -3 with the dose adjusted to maintain a level of 200-400 mg/mL * MMF: 1 gram IV three times a day (TID) if greater than 50 kg, or 15 mg/kg IV TID if less than 50 kg beginning on Day -3; continued until Day 30 or 7 days after engraftment, whichever day is later Day 0 is the day of the infusion of the umbilical cord blood graft units, which will be obtained from partially HLA-matched unrelated donors. Beginning on Day 1, participants will receive G-CSF 5 mcg/kg/day until absolute neutrophil count (ANC) is greater than or equal to 2,000/mm^3 for three consecutive measurements, each on different days. | Biological | Umbilical Cord Blood Transplantation |
Primary outcome
Overall Survival at 180 Days From the Time of Transplant
Time frame: Measured at Month 6 and Year 1
11 secondary outcomes
Neutrophil Recovery
Time frame: Measured at Days 28, 56, 90, and 100
Primary Graft Failure
Time frame: Measured at Day 100
Secondary Graft Failure
Time frame: Measured at Day 100
Platelet Recovery to 20K
Time frame: Measured at Days 56, 90, and 100
Donor Cell Engraftment
Time frame: Measured at Day 56
Acute Graft-versus-host Disease (GVHD)
Time frame: Measured at Day 100
Chronic GVHD
Time frame: Measured at Year 1
Progression-free Survival
Time frame: Measured at Year 1
Treatment-related Mortality (TRM)
Time frame: Measured at 6 months and 1 year
Incidence of Infections
Time frame: Measured at Year 1
Platelet Recovery to 50K
Time frame: Measured at Days 56, 90, and 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21527516Brunstein CG, Fuchs EJ, Carter SL, Karanes C, Costa LJ, Wu J, Devine SM, Wingard JR, Aljitawi OS, Cutler CS, Jagasia MH, Ballen KK, Eapen M, O'Donnell PV; Blood and Marrow Transplant Clinical Trials Network. Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood. 2011 Jul 14;118(2):282-8. doi: 10.1182/blood-2011-03-344853. Epub 2011 Apr 28.
- Results publication: PubMed 24862638Eapen M, O'Donnell P, Brunstein CG, Wu J, Barowski K, Mendizabal A, Fuchs EJ. Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Oct;20(10):1485-92. doi: 10.1016/j.bbmt.2014.05.015. Epub 2014 May 23.
- Individual participant dataSharing planned: No. Findings will be published in a manuscript.
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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. This study is not recruiting at the moment.
Mary Horowitz, MD, MS study director
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hematopoietic Umbilical Cord Blood Stem Cell Transplantation and GVHD prophylaxis in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Leukemia, Myeloid, Acute, run by Medical College of Wisconsin at 16 sites 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 12 inclusion and 7 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: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival at 180 Days From the Time of Transplant (time frame: Measured at Month 6 and Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864227, which also lists 2 linked publications.
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 14 Dec 2022.