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CompletedNCT01093586Updated Jan 23, 2019Results posted

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

A Phase 2 interventional study of double-unit umbilical cord blood transplantation and cytogenetic analysis in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Megakaryoblastic Leukemia (M7), sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 12 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
12 Years to 64 Years
Sex
All
01

Study summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) 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 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. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.

SECONDARY OBJECTIVES:

  1. To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
  2. To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
  3. To determine the probability of overall survival and disease free survival at one and two years.
  4. To describe the incidence of disease recurrence at one and two years in patients post UCBT.
  5. To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
  6. To determine the incidence of day 100 and 180 treatment related mortality.
  7. To determine the incidence of serious infectious complications in the first year after transplant.
  8. To determine the incidence of donor-derived neutrophil and platelet recovery.
  9. To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1.

TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.

02

Conditions studied

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Erythroleukemia (M6a)
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Adult Pure Erythroid Leukemia (M6b)
  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Childhood Acute Lymphoblastic Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Burkitt Lymphoma
  • Childhood Acute Erythroleukemia (M6)
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Megakaryocytic Leukemia (M7)
  • Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Childhood Acute Monoblastic Leukemia (M5a)
  • Childhood Acute Monocytic Leukemia (M5b)
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • de Novo Myelodysplastic Syndromes
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Nodal Marginal Zone B-cell Lymphoma
  • Previously Treated Myelodysplastic Syndromes
  • Prolymphocytic Leukemia
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Relapsing Chronic Myelogenous Leukemia
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Secondary Myelofibrosis
  • Splenic Marginal Zone Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia
  • T-cell Adult Acute Lymphoblastic Leukemia
  • T-cell Childhood Acute Lymphoblastic Leukemia
  • T-cell Large Granular Lymphocyte Leukemia
  • Waldenstrom Macroglobulinemia
03

In context

Leukemia, Megakaryoblastic, Acute

172 studies on the registry are indexed under Leukemia, Megakaryoblastic, Acute; none are open to participants now.

This study's enrollment of 14 is below the median of 45 across 137 interventional studies indexed under Leukemia, Megakaryoblastic, Acute.

Browse Leukemia, Megakaryoblastic, Acute studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Browse Case Comprehensive Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients will be diagnosed with one of the following hematological : acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
  • AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
  • AML--Second remission (CR2) or subsequent remission
  • AML--Relapse/Persistent Disease with \< 20% bone marrow blasts
  • ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14)
  • ALL--Second remission (CR2) or subsequent remission
  • ALL--Relapse/Persistent Disease with \< 20% bone marrow blasts
  • Non-Hodgkin Lymphoma--Induction failure or relapse and sensitive to most recent chemotherapy
  • MDS--Low or Intermediate-1 International Prognostic Scoring System (IPSS) score with: life-threatening cytopenia(s); and/or red cell or transfusion dependence
  • MDS--ANC \< 500, recurrent infections, PRBC transfusions > 2 units/month, poor risk cytogenetics, platelet transfusion dependence
  • MDS--Intermediate-2 or High IPSS score
  • CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase inhibitors (i.e. imatinib, dasatinib, etc.)
  • CML--CP2 or subsequent chronic phase, including chronic phase achieved after induction therapy for blast crisis
  • Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by a consensus of the physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee
  • Myeloproliferative and lymphoproliferative disorders--must have evidence of disease acceleration to be a candidate for umbilical cord blood transplant; myeloproliferative disorders eligible for transplant include chronic myelomonocytic leukemia (CMML) with high IPSS score and myelofibrosis
  • Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative disorders eligible for transplant include chronic lymphocytic leukemia, prolymphocytic leukemia, and large granular lymphocytic leukemia
  • Good performance status: >= 70 % or 0-1
  • Calculated >= 60 mL/min, or measured creatinine clearance >= 60 mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal dysfunction
  • Hepatic Transaminases \< 4 x upper limit normal (); total \< 2.5 mg/dL, unless the patient has a history of benign congenital hyperbilirubinemia (Gilbert's syndrome)
  • Normal cardiac function by echocardiogram or radionuclide scan, ( > 45%); if the left ventricular ejection fraction is between 40-50%, clearance by an adult cardiologist is required
  • Pulmonary function tests demonstrating > 60% of predicted for age
  • Adults must have a DLCOva > 60% normal
  • For patients unable to complete pulmonary function tests clearance by an adult pulmonologist is required
  • Patients will be eligible for the clinical trial under the following conditions: they do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a 6/6 HLA-identical matched unrelated adult donor; OR a matched related donor transplant is not in the best interest of the patient (i.e., patient's condition precludes waiting on the donor, too much time to prepare the donor, the donor is ineligible due to medical reasons, or in the case of high risk disease a related donor is not appropriated (syngeneic transplant); the decision must be agreed upon by the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee; OR their condition precludes waiting to search and find a donor in the National Marrow Donor Registry

Exclusion criteria

Exclusion Criteria:

  • Female patients who are pregnant or breast-feeding
  • or HTLV-1 positivity
  • Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
  • Active extramedullary leukemia, including CNS disease
  • Prior hematopoietic stem cell transplant (autologous or allogeneic)
  • Uncontrolled infection
  • Patient has an identical related bone marrow donor or a 6/6 HLA-identical matched unrelated donor
  • Any patient who is unable to provide or comply with the requirements of the protocol
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Arm I

    PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.

    Procedure: double-unit umbilical cord blood transplantation · Other: cytogenetic analysis · Procedure: bone marrow aspiration · Other: fluorescence in situ hybridization · Drug: busulfan · Drug: cyclophosphamide · Drug: anti-thymocyte globulin · Drug: methylprednisolone · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: flow cytometry · Procedure: allogeneic hematopoietic stem cell transplantation

Interventions

  • Proceduredouble-unit umbilical cord blood transplantation

    Undergo transplantation

  • Othercytogenetic analysis

    Correlative studies

  • Procedurebone marrow aspiration

    Correlative studies

  • Otherfluorescence in situ hybridization

    Correlative studies

    Also known as: fluorescence in situ hybridization (FISH)

  • Drugbusulfan

    Given orally

    Also known as: BSF, BU, Misulfan, Mitosan, Myeloleukon, Myelosan

  • Drugcyclophosphamide

    Given IV

    Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana, Enduxan

  • Druganti-thymocyte globulin

    Given IV

    Also known as: ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin

  • Drugmethylprednisolone

    Given IV

    Also known as: A-MethaPred, Depo-Medrol, Medrol, MePRDL, Solu-Medrol, Wyacort

  • Drugcyclosporine

    Given IV

    Also known as: 27-400, ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune

  • Drugmycophenolate mofetil

    Given orally or IV

    Also known as: Cellcept, MMF

  • Otherflow cytometry

    Correlative studies

  • Procedureallogeneic hematopoietic stem cell transplantation

    Undergo transplantation

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Number of participants alive at 180 days post engraftment.

    Time frame: On day +180

Secondary outcomes

  1. Hematologic Engraftment

    Number of participants that were able to complete engraftment by day 42.

    Time frame: On day +42

  2. Overall Survival

    Number of participants that were alive.

    Time frame: At 1 year

  3. Overall Survival

    Number of participants that were alive.

    Time frame: At 2 years

  4. Disease Free

    Number of participants that were disease free

    Time frame: At 1 year

  5. Disease Free

    Number of participants that were disease free

    Time frame: At 2 years

  6. Recurrence or Relapse

    Number of subjects that had disease recurrence

    Time frame: one year in patients post UCBT

  7. Recurrence or Relapse

    Number of subjects that had disease recurrence

    Time frame: two years post transplant

  8. Transplant Related Mortality

    Number of subjects that died because of transplant

    Time frame: On day 100 post transplant

  9. Transplant Related Mortality

    Number of subjects that died because of transplant

    Time frame: On day 180 post transplant

  10. Occurrence of Serious Infections

    Number of participants that had infections

    Time frame: 1 year

  11. Immune Reconstitution

    Immunodificency panel to see recovery of immune system. Number of participants that recovered.

    Time frame: Periodically for 2 years

  12. Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0

    Number of participants that experienced toxicity related to the transplant

    Time frame: by day +42

  13. Incidence of Acute Graft-versus-host Disease (GVHD)

    Number of participants that had acute GVHD

    Time frame: At 100 days

  14. Incidence of Chronic GVHD

    Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)

    Time frame: At 1 year

07

Results

Posted Jan 4, 2019

Participant flow

Participants recruited from medical hospital from 9/2007 thru 2/2013.

Participant flow — Overall Study
MilestoneArm I
Started14
Completed11
Not completed3
Withdrew: Failed to engraft3

Outcome measures

PrimaryOverall Survival

Number of participants alive at 180 days post engraftment.

Time frame:
On day +180
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsArm I
Overall Survival8
SecondaryHematologic Engraftment

Number of participants that were able to complete engraftment by day 42.

Time frame:
On day +42
Reported as:
Count of participants · Participants
Hematologic Engraftment
ParticipantsArm I
Hematologic Engraftment10
SecondaryOverall Survival

Number of participants that were alive.

Time frame:
At 1 year
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsArm I
Overall Survival6
SecondaryOverall Survival

Number of participants that were alive.

Time frame:
At 2 years
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsArm I
Overall Survival4
SecondaryDisease Free

Number of participants that were disease free

Time frame:
At 1 year
Reported as:
Count of participants · Participants
Disease Free
ParticipantsArm I
Disease Free4
SecondaryDisease Free

Number of participants that were disease free

Time frame:
At 2 years
Reported as:
Count of participants · Participants
Disease Free
ParticipantsArm I
Disease Free4
SecondaryRecurrence or Relapse

Number of subjects that had disease recurrence

Time frame:
one year in patients post UCBT
Reported as:
Count of participants · Participants
Recurrence or Relapse
ParticipantsArm I
Recurrence or Relapse2
SecondaryRecurrence or Relapse

Number of subjects that had disease recurrence

Time frame:
two years post transplant
Reported as:
Count of participants · Participants
Recurrence or Relapse
ParticipantsArm I
Recurrence or Relapse2
SecondaryTransplant Related Mortality

Number of subjects that died because of transplant

Time frame:
On day 100 post transplant
Reported as:
Count of participants · Participants
Transplant Related Mortality
ParticipantsArm I
Transplant Related Mortality2
SecondaryTransplant Related Mortality

Number of subjects that died because of transplant

Time frame:
On day 180 post transplant
Reported as:
Count of participants · Participants
Transplant Related Mortality
ParticipantsArm I
Transplant Related Mortality6
SecondaryOccurrence of Serious Infections

Number of participants that had infections

Time frame:
1 year
Reported as:
Count of participants · Participants
Occurrence of Serious Infections
ParticipantsArm I
Occurrence of Serious Infections13
SecondaryImmune Reconstitution

Immunodificency panel to see recovery of immune system. Number of participants that recovered.

Time frame:
Periodically for 2 years

No measurements were reported for this outcome.

SecondaryToxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0

Number of participants that experienced toxicity related to the transplant

Time frame:
by day +42
Reported as:
Count of participants · Participants
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
ParticipantsArm I
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.08
SecondaryIncidence of Acute Graft-versus-host Disease (GVHD)

Number of participants that had acute GVHD

Time frame:
At 100 days
Reported as:
Count of participants · Participants
Incidence of Acute Graft-versus-host Disease (GVHD)
ParticipantsArm I
Incidence of Acute Graft-versus-host Disease (GVHD)11
SecondaryIncidence of Chronic GVHD

Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)

Time frame:
At 1 year
Reported as:
Count of participants · Participants
Incidence of Chronic GVHD
ParticipantsArm I
Incidence of Chronic GVHD1

Adverse events

Collected over Adverse Events were collected from participant start on study to going off study up to a period of 2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I11/14 (78.6%)9/14 (64.3%)—
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventArm I
HypoxiaRespiratory, thoracic and mediastinal disorders4/14
DiarrheaGastrointestinal disorders3/14
Death not associated with CTCAE term - Multi-organ failureGeneral disorders3/14
Death not associated with CTCAE term - Death NOSGeneral disorders2/14
Infection with normal ANC or Grade 1 or 2 neutrophilsProduct Issues2/14
Supraventricular and nodal arrhythmia - Sinus tachycardiaCardiac disorders1/14
Hemorrhage, pulmonary/upper respiratory - NoseRespiratory, thoracic and mediastinal disorders1/14
Bilirubin (hyperbilirubinemia)Hepatobiliary disorders1/14
HypotensionCardiac disorders1/14
Bone marrow cellularity - Primary graft failureBlood and lymphatic system disorders1/14

Baseline characteristics

Age, Customized
Age, Customized(Participants)Arm I
10-19 yrs2
20-29 yrs2
30-39 yrs3
40-49 yrs5
50-59 yrs2
Sex: Female, Male
Sex: Female, Male(Participants)Arm I
Female8
Male6
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I
Hispanic or Latino0
Not Hispanic or Latino13
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White11
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Arm I
United States14
08

Study locations

1 site
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2019, 3 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2010
First posted
Mar 26, 2010
Start
Sep 2007
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Results first posted
Jan 4, 2019
Last update
Jan 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01093586
Lead sponsor
Case Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Mar 26, 2010
Start date
Sep 2007
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Jan 4, 2019
Last update
Jan 23, 2019

Study contacts

Brenda Cooper, MD
principal investigator · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Busulfan · Cyclophosphamide · Antilymphocyte Serum · Methylprednisolone · Cyclosporine · Mycophenolic Acid

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