Acute Lymphoblastic LeukemiaPhase 2NCT00723099
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Cyclosporine in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Fred Hutchinson Cancer Center at 6 sites in United States.
Trial summary
This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's… Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma
- What is being tested?
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Cyclosporine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Jun 2008to 31 Jul 2018
- 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients > 70 may be considered if performance status > 80% or Eastern Cooperative Oncology Group (ECOG) =< 1 and comorbidity score < 3; these patients must be discussed with the principal investigator (PI), Rachel Salit prior to enrollment
- Adequate cardiac function defined as absence of decompensated congestive heart failure, or uncontrolled arrhythmia and:
- Left ventricular ejection fraction >= 35% or
- Fractional shortening > 22%
- Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements
- Adequate hepatic function; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
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- Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine clearance > 40 ml/min (pediatrics)
- All adults with a creatinine > 1.2 or a history of renal dysfunction must have estimated creatinine clearance > 40 ml/min
- Performance status score: Karnofsky (for adults) >= 60 or ECOG 0-2; Lansky (for children) score >= 50
- If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease
- Second hematopoietic cell transplant: Must be >= 3 months after prior myeloablative transplant
- Patients who have received < 2 cycles of multiagent chemotherapy and patients who have received no multiagent chemotherapy within the 3 months previous to umbilical cord blood transplant (UCBT) as well as patients experiencing graft failure following previous allogeneic transplant
- Acute myeloid leukemia/acute lymphoblastic leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia: Must have < 5% morphologic marrow blasts in an evaluable marrow (> 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with the approval of the PI or designee
- Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors; at time of transplant, patients must have < 5% blasts in an evaluable marrow (> 25% of normal cellularity for age) by morphology within the bone marrow
- Myelodysplastic syndrome (MDS): Any subtype; morphologic blasts must be less than 5% in an evaluable marrow (> 25% of normal cellularity for age); if blasts are 5% or more, patient requires induction chemotherapy pre-transplant to reduce blast count to less than 5%; patients who have a hypocellular marrow in the absence of excess blasts that is related to the underlying disease or as a result of treatment for MDS may also be eligible with the approval of the PI or designee
- Large-cell lymphoma and aggressive T-cell lymphoma: With chemotherapy sensitive disease that has failed autologous transplant or patients who are ineligible for an autologous transplant; chemotherapy sensitive disease is defined as >= 50% reduction in the size of the tumor with the chemotherapy regimen immediately preceding transplant
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory to fludarabine (fludarabine phosphate) or fail to have a complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. cladribine [2-CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog)
- Hodgkin disease: Must have received and failed frontline therapy
- Follicular lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, and indolent T-cell lymphomas: Must have progressed with the most recent remission duration being < 6 months; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless they have bulky disease and an estimated tumor doubling time of less than one month
- Multiple myeloma: Must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative hematopoietic cell transplant (HCT) is permitted
- Myeloproliferative syndromes
- DONOR: Cord blood (CB) donor selection will be based on institutional guidelines and in general should be selected to optimize both human leukocyte antigen (HLA) match and cell dose; additionally, CB grafts shall consist of one or two CB donors based on, but not exclusively determined by, cell dose (total nucleated cell [TNC]/kg and CD34/kg), HLA matching and disease status and indication for transplant; attending preference will be allowed for single versus double unit as well as the degree of mismatching based on patient specific factors, as long as the following minimum criteria are met:
- HLA matching
- Minimum requirement: The CB graft(s) must be matched at a minimum at 4/6 HLA-A, B, DRB1 loci with the recipient. Therefore 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match is allowed
- HLA-matching determined by high-resolution typing is allowed per institutional guidelines as long as the minimum criteria are met
- Selection of two CB units is mandatory when a single cord blood unit does not meet the following criteria:
- Match grade 6/6; TNC Dose >= 2.5 x 10^7/kg
- Match grade 5/6 or 4/6; TNC dose >= 4.0 (+/- 0.5) x 10^7/kg
- If two CB units are used, the total cell dose of the combined units must be at least 3.0 x 10^7 TNC per kilogram recipient weight based on pre-cryopreservation numbers, with each CB unit containing a MINIMUM of 1.5 x 10^7 TNC/kg
- The minimum recommended CD34/kg cell dose should be 2 x 10^5 CD34/kg, total dose from a single or combined double
- The unmanipulated CB unit(s) will be Food and Drug Administration (FDA) licensed or will be obtained under a separate investigational new drug (IND), such as the National Marrow Donor Program (NMDP) Protocol 10-CBA conducted under BB IND-7555 or another IND sponsored by (1) a participating institution or (2) an investigator at FHCRC or one of the participating institutions
- FHCRC only: Up to 5% of cord blood product, when ready for infusion, may be withheld for research purposes as long as thresholds for infused TNC dose are met; threshold for double unit transplantation is >= 3.0 x 10^7/kg; these products will be used to conduct studies involving the immunobiology of double cord transplantation and kinetics of engraftment
Who cannot join
- Patients with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
- Uncontrolled viral or bacterial infection at the time of study enrollment
- Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
- Active central nervous system malignancy
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- Patients who have received >= 2 cycles of multiagent chemotherapy within the 3 months previous to UCBT; patients who have had previous autologous transplant within 12 months of UCBT are excluded regardless of history of recent treatment
- DONOR: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram recipient weight
- DONOR: Any cord blood units without the full maternal testing and negative results for hepatitis A, B, C, HIV, and human T-lymphotropic virus (HTLV-1) viruses; any additional available virology results on the unit itself will be reviewed but are not mandated, complete or always available; cord blood units are presumed to be cytomegalovirus (CMV) negative regardless of serologic testing due to passive transmission of maternal CMV antibodies
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
LDS Hospital
Salt Lake City, Utah, 84143
VA Puget Sound Health Care System
Seattle, Washington, 98101
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC)
This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
Read the detailed description
PRIMARY OBJECTIVES:
- Estimate probability of one year survival.
II. Demonstrate equivalent or improved engraftment rates with a non-anti-thymocyte globulin (ATG) based conditioning regimen. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host cluster of differentiation (CD)3 peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day 55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment (< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at count recovery and without relapse
SECONDARY OBJECTIVES:
- Six month non-relapse mortality.
II. Overall incidence of graft failure/rejection. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host CD3 peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day 55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment (< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at count recovery and without relapse
III. Kinetics of chimeric reconstitution.
IV. Incidence of neutrophil engraftment by day 42.
- Incidence of platelet engraftment by six months.
VI. Incidence of grade II-IV and III-IV acute graft-versus-host disease (GvHD) at day 100.
VII. Incidence of one year chronic GvHD.
VIII. Incidence of clinically significant infections at 6 months, 1 year, 2 years.
IX. Probability of one and two year survival.
- Incidence of one and two year relapse or disease progression.
XI. Fred Hutchinson Cancer Research Center (FHCRC) patients: Kinetics of immune reconstitution, with both functional and quantitative assays.
XII. FHCRC patients: Examination of possible immunologic factors leading to emergence of a dominant unit.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo a lower dose of total-body irradiation (TBI) on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to +180 and mycophenolate mofetil IV or orally (PO) every 8 hours on days 0 to +96.
After completion of study treatment, patients are followed periodically for up to 2 years.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Indolent Non-Hodgkin Lymphoma
- Being tested
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase, Lymphoma, Leukemia, Biphenotypic, Acute, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT
Undergo umbilical cord blood transplant
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
CyclosporineDrug
Also called 27-400, Ciclosporin, CsA, Cyclosporin
Given IV
Also called 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Also called Cellcept, MMF
Given IV or PO
Total-Body IrradiationRadiation
Also called Total Body Irradiation, Whole-Body Irradiation
Undergo TBI
Umbilical Cord Blood TransplantationProcedure or surgery
Also called Cord Blood Transplantation, UCB transplantation
Undergo umbilical cord blood transplant
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy, transplant) | Experimental | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo a lower dose of TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Cyclophosphamide; Drug: Cyclosporine; Drug: Fludarabine Phosphate; Other: Laboratory Biomarker Analysis; Drug: Mycophenolate Mofetil; Radiation: Total-Body Irradiation; Procedure: Umbilical Cord Blood Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Kaplan-Meier and cumulative incidence estimates will be used.
Measured: At 1 year
Secondary outcomes (8)
Median Time to ANC > 500
Measured: By day 55
Number of Participants With Graft Failure/Rejection
descriptive
Measured: By day 55
Time to Platelet Engraftment of > 20,000 Cells Per mm3
median and range
Measured: By 6 months
Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria
Measured: By day 100
Percent of Patients With Acute GVHD Grades III-IV
Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria
Measured: 100 days
Percent of Patients With Chronic GVHD
Kaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria.
Measured: At 2 years
Percent of Patients With Non-relapse Mortality
Kaplan-Meier and cumulative incidence estimates
Measured: 6 months
Percent of Patients With Non-relapse Mortality
Kaplan-Meier and cumulative incidence estimates
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study start25 Jun 2008
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
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.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rachel Salit, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723099
- Sponsor's protocol ID
- 2239.00
- Other IDs
- NCI-2009-01551, 2239, 2239.00, P30CA015704
- Status last verified
- Dec 2019
- First submitted
- 25 Jul 2008
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC)
- ClinicalTrials.gov ID
- NCT00723099
- Acronym / sponsor ID
- 2239.00
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Indolent Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jun 2008 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
Detailed description
PRIMARY OBJECTIVES:
- Estimate probability of one year survival.
II. Demonstrate equivalent or improved engraftment rates with a non-anti-thymocyte globulin (ATG) based conditioning regimen. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host cluster of differentiation (CD)3 peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day 55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment (< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at count recovery and without relapse
SECONDARY OBJECTIVES:
- Six month non-relapse mortality.
II. Overall incidence of graft failure/rejection. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host CD3 peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day 55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment (< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at count recovery and without relapse
III. Kinetics of chimeric reconstitution.
IV. Incidence of neutrophil engraftment by day 42.
- Incidence of platelet engraftment by six months.
VI. Incidence of grade II-IV and III-IV acute graft-versus-host disease (GvHD) at day 100.
VII. Incidence of one year chronic GvHD.
VIII. Incidence of clinically significant infections at 6 months, 1 year, 2 years.
IX. Probability of one and two year survival.
- Incidence of one and two year relapse or disease progression.
XI. Fred Hutchinson Cancer Research Center (FHCRC) patients: Kinetics of immune reconstitution, with both functional and quantitative assays.
XII. FHCRC patients: Examination of possible immunologic factors leading to emergence of a dominant unit.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo a lower dose of total-body irradiation (TBI) on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to +180 and mycophenolate mofetil IV or orally (PO) every 8 hours on days 0 to +96.
After completion of study treatment, patients are followed periodically for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy, transplant) | Experimental | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Drug: Cyclophosphamide, Drug: Cyclosporine, Drug: Fludarabine Phosphate, Other: Laboratory Biomarker Analysis, Drug: Mycophenolate Mofetil, Radiation: Total-Body Irradiation, Procedure: Umbilical Cord Blood TransplantationCONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo a lower dose of TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (32 listed)
- Patients > 70 may be considered if performance status > 80% or Eastern Cooperative Oncology Group (ECOG) =< 1 and comorbidity score < 3; these patients must be discussed with the principal investigator (PI), Rachel Salit prior to enrollment
- Adequate cardiac function defined as absence of decompensated congestive heart failure, or uncontrolled arrhythmia and:
- Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) > 30% predicted, and absence of oxygen (O2) requirements
- Adequate hepatic function; patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease will be excluded
- Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine clearance > 40 ml/min (pediatrics)
Key exclusion criteria (9 listed)
- Patients with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
- Uncontrolled viral or bacterial infection at the time of study enrollment
- Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
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 |
|---|---|---|
| Allogeneic Hematopoietic Stem Cell TransplantationAlso: Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCTUndergo umbilical cord blood transplant | Procedure or surgery | Treatment (chemotherapy, transplant) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Treatment (chemotherapy, transplant) |
| CyclosporineAlso: 27-400, Ciclosporin, CsA, CyclosporinGiven IV | Drug | Treatment (chemotherapy, transplant) |
| Fludarabine PhosphateAlso: 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, FludaraGiven IV | Drug | Treatment (chemotherapy, transplant) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (chemotherapy, transplant) |
| Mycophenolate MofetilAlso: Cellcept, MMFGiven IV or PO | Drug | Treatment (chemotherapy, transplant) |
| Total-Body IrradiationAlso: Total Body Irradiation, Whole-Body IrradiationUndergo TBI | Radiation | Treatment (chemotherapy, transplant) |
| Umbilical Cord Blood TransplantationAlso: Cord Blood Transplantation, UCB transplantationUndergo umbilical cord blood transplant | Procedure or surgery | Treatment (chemotherapy, transplant) |
Primary outcome
Overall Survival
Time frame: At 1 year
Kaplan-Meier and cumulative incidence estimates will be used.
8 secondary outcomes
Median Time to ANC > 500
Time frame: By day 55
Number of Participants With Graft Failure/Rejection
Time frame: By day 55
Time to Platelet Engraftment of > 20,000 Cells Per mm3
Time frame: By 6 months
Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
Time frame: By day 100
Percent of Patients With Acute GVHD Grades III-IV
Time frame: 100 days
Percent of Patients With Chronic GVHD
Time frame: At 2 years
Percent of Patients With Non-relapse Mortality
Time frame: 6 months
Percent of Patients With Non-relapse Mortality
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rachel Salit principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 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 Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide and Cyclosporine in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by Fred Hutchinson Cancer Center at 6 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 32 inclusion and 9 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 11 Oct 2019). 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 (time frame: At 1 year). 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 27 Dec 2019.