Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2NCT00849147
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
A Phase 2 study testing Haploidentical Bone Marrow Transplantation and GVHD prophylaxis in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Leukemia, Myeloid, Acute, run by Medical College of Wisconsin at 17 sites in United States.
Trial summary
Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. 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?
- Haploidentical Bone Marrow Transplantation and GVHD prophylaxis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 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)
- Donor must be at least 18 years of age
- Human leucocyte antigen (HLA) typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and -DQB1 loci. A minimum match of 5/10 is required. An 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. The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.
- 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 13Show fewer
- Lymphoma
- Patients with adequate physical function as measured by the following:
- Heart: left ventricular ejection fraction at rest must be greater than or equal to 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 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) is greater than 40 mL/min/1.73m^2
- Pulmonary: 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.
- Performance status: Karnofsky/Lansky score greater than or equal to 60%
Who cannot join
- Have an HLA-matched, related, or 7 or 8/8 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bone Marrow Transplant Group of Georgia, Northside Hospital
Atlanta, Georgia, 30342
University of Maryland, Greenbaum Cancer Center
Baltimore, Maryland, 21201
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center (SKCCC)
Baltimore, Maryland, 21231
DFCI, Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Baylor University Medical Center
Dallas, Texas, 75246
Karmanos Cancer Institute, Children's Hospital of Michigan
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-0277
Kapi'olani Medical Center for Women and Children, University of Hawaii
Honolulu, Hawaii, 96826
University of California San Diego Medical Center
La Jolla, California, 92093
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8210
Fox Chase, Temple University
Philadelphia, Pennsylvania, 19111-2442
Oregon Health & Science University
Portland, Oregon, 97239-3098
Texas Transplant Institute
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow From Related Donors for Patients With Hematologic Malignancies (BMT CTN #0603)
Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant-one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow-in 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, a bone marrow transplant is another treatment option. In a bone marrow transplant procedure, healthy bone marrow is taken from a donor and transplanted into the patient. Bone marrow can be donated by a family member or an unrelated donor who has a similar type of bone marrow. Most bone marrow transplants are performed using a donor who is a perfect or close-to-perfect tissue match. However, for participants in this study, researchers have determined that a completely matched donor is unavailable within participants' families, and an unrelated donor match has not been found either. Participants do, however, have a family member who is a partial tissue match. Typically, people who are undergoing a bone marrow transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor bone marrow. In this study, participants will undergo a new type of bone marrow 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 bone marrow transplant that uses partially matched bone marrow donated by a family member as a treatment option for people with leukemia or lymphoma.
This study will enroll people with leukemia or lymphoma who have a family member with a partial tissue match. Participants will be admitted to the hospital and will first receive a type of chemotherapy called fludarabine, which will be given intravenously for 5 days. In addition, another type of chemotherapy, cyclophosphamide, will be given intravenously on the first and second day. After 5 days, participants will receive a small dose of radiation. The next day, participants will undergo the bone marrow transplant. The third and fourth day after the transplant, participants will receive high doses of cyclophosphamide to help prevent two complications, graft rejection, which occurs when the body's immune system rejects the donor bone marrow, and graft-versus-host disease (GVHD), which is an attack by the donor cells on the body's normal tissues. On the fifth day after the transplant, participants will receive two additional medications, tacrolimus and mycophenolate mofetil (MMF), to help prevent GVHD; some participants may receive cyclosporine instead of tacrolimus. Participants will receive MMF for about 5 weeks and tacrolimus for about 6 months. Also beginning on the fifth 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 remain in the hospital for approximately 2 to 3 months, but possibly longer if there are complications. 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. Follow-up study visits will occur 6 months and 1 year after the transplant. At Months 1, 2, 6, and 12 after the transplant, blood or bone marrow 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
- Haploidentical Bone Marrow Transplantation, GVHD prophylaxis
- Keywords
- Acute Lymphoblastic Leukemia/Lymphoma, Acute Myelogenous Leukemia, Mantel-Cell Lymphoma, Hematopoietic Transplant, Haplo-Identical Transplant, 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.
Haploidentical Bone Marrow TransplantationBiological
The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
- Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2
- Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5
- Total body irradiation (TBI): 200 centigray (cGy) on Day -1
Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor.
GVHD prophylaxisBiological
The GVHD prophylaxis regimen will consist of the following:
- Cy: 50 mg/kg IV on Days 3 and 4
- Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL
- Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID
- Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm^3 for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Haploidentical Bone Marrow Transplant | Experimental | Participants will receive a human leucocyte antigen (HLA) haploidentical bone marrow transplantation using a non-myeloablative preparative regimen, GVHD prophylaxis. Receives: Biological: Haploidentical Bone Marrow 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
Cumulative incidence of neutrophil recovery >500/μL at day +56
Measured: Measured at Days 28, 56, 90, and 100
Primary Graft Failure
Primary graft failure is defined as < 5% donor chimerism on all measurements.
Measured: Measured at Day 67
Secondary Graft Failure
Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.
Measured: Measured at Day 100
Platelet Recovery
Platelet Recovery to 20K
Measured: Measured at Days 56, 90, and 100
Platelet Recovery
Platelet Recovery to 50K
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 of the times to relapse/recurrence, to death or to last follow-up.
Measured: Measured at Year 1
Treatment-related Mortality (TRM)
Measured: Measured at 6 months and 1 year
Infections
Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJun 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
- 55 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
- NCT00849147
- Sponsor's protocol ID
- BMTCTN0603
- Other IDs
- U01HL069294, 5U24CA076518
- Status last verified
- Dec 2022
- First submitted
- 20 Feb 2009
- Last updated
- 4 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow From Related Donors for Patients With Hematologic Malignancies (BMT CTN #0603)
- ClinicalTrials.gov ID
- NCT00849147
- Acronym / sponsor ID
- BMTCTN0603
- 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, Haplo-Identical Transplant, Non-Myeloablative Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 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
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant-one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow-in 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, a bone marrow transplant is another treatment option. In a bone marrow transplant procedure, healthy bone marrow is taken from a donor and transplanted into the patient. Bone marrow can be donated by a family member or an unrelated donor who has a similar type of bone marrow. Most bone marrow transplants are performed using a donor who is a perfect or close-to-perfect tissue match. However, for participants in this study, researchers have determined that a completely matched donor is unavailable within participants' families, and an unrelated donor match has not been found either. Participants do, however, have a family member who is a partial tissue match. Typically, people who are undergoing a bone marrow transplant receive high doses of chemotherapy before the transplant to prepare their bodies to accept the donor bone marrow. In this study, participants will undergo a new type of bone marrow 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 bone marrow transplant that uses partially matched bone marrow donated by a family member as a treatment option for people with leukemia or lymphoma.
This study will enroll people with leukemia or lymphoma who have a family member with a partial tissue match. Participants will be admitted to the hospital and will first receive a type of chemotherapy called fludarabine, which will be given intravenously for 5 days. In addition, another type of chemotherapy, cyclophosphamide, will be given intravenously on the first and second day. After 5 days, participants will receive a small dose of radiation. The next day, participants will undergo the bone marrow transplant. The third and fourth day after the transplant, participants will receive high doses of cyclophosphamide to help prevent two complications, graft rejection, which occurs when the body's immune system rejects the donor bone marrow, and graft-versus-host disease (GVHD), which is an attack by the donor cells on the body's normal tissues. On the fifth day after the transplant, participants will receive two additional medications, tacrolimus and mycophenolate mofetil (MMF), to help prevent GVHD; some participants may receive cyclosporine instead of tacrolimus. Participants will receive MMF for about 5 weeks and tacrolimus for about 6 months. Also beginning on the fifth 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 remain in the hospital for approximately 2 to 3 months, but possibly longer if there are complications. 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. Follow-up study visits will occur 6 months and 1 year after the transplant. At Months 1, 2, 6, and 12 after the transplant, blood or bone marrow 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 |
|---|---|---|
| Haploidentical Bone Marrow Transplant | Experimental | Biological: Haploidentical Bone Marrow Transplantation, Biological: GVHD prophylaxisParticipants will receive a human leucocyte antigen (HLA) haploidentical bone marrow 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 (13 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)
- Donor must be at least 18 years of age
- Human leucocyte antigen (HLA) typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and -DQB1 loci. A minimum match of 5/10 is required. An 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. The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.
- 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 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 |
|---|---|---|
| Haploidentical Bone Marrow TransplantationThe transplant preparative regimen is listed below. The - sign is the number of days before the transplant. * Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2 * Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5 * Total body irradiation (TBI): 200 centigray (cGy) on Day -1 Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor. | Biological | Haploidentical Bone Marrow Transplant |
| GVHD prophylaxisThe GVHD prophylaxis regimen will consist of the following: * Cy: 50 mg/kg IV on Days 3 and 4 * Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL * Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID * Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm^3 for 3 consecutive days | Biological | Haploidentical Bone Marrow Transplant |
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 67
Secondary Graft Failure
Time frame: Measured at Day 100
Platelet Recovery
Time frame: Measured at Days 56, 90, and 100
Platelet Recovery
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
Infections
Time frame: Measured at Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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: Yes. Results 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
17 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 Haploidentical Bone Marrow Transplantation and GVHD prophylaxis in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma and Leukemia, Myeloid, Acute, run by Medical College of Wisconsin at 17 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 13 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 7 Sep 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 NCT00849147, 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 4 Jan 2023.