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TerminatedNCT00608517Updated May 20, 2014Results posted

Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

An interventional study of anti-thymocyte globulin and cyclophosphamide in Graft Versus Host Disease, Leukemia and Lymphoma, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 4 sites in United States. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2014-05-20.

Sponsored by Vanderbilt-Ingram Cancer Center · Not applicable, Interventional, and Treatment

Why this study was terminated
slow accrual
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
Up to 50 Years
Sex
All
01

Study summary

RATIONALE: Giving chemotherapy and total-body irradiation 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 a donor 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 tacrolimus and mycophenolate mofetil before and after transplant may stop this from happening.

PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated donors to serve as a source of stem cells for people needing a bone marrow transplant.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the safety (as assessed by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord stem cell transplantation in patients with hematological malignancies receiving graft-versus-host disease (GVHD) prophylaxis comprising tacrolimus and mycophenolate mofetil (MMF).

Secondary

  • To assess sustained donor engraftment, neutrophil recovery, platelet recovery, incidence and severity of acute graft-versus-host disease (GVHD) and chronic GVHD, relapse rate, 100-day all-cause mortality, overall survival, and immune reconstitution after single or double umbilical cord stem cell transplantation in patients with hematologic malignancies receiving graft-versus-host disease(GVHD) prophylaxis comprising tacrolimus and mycophenolate mofetil (MMF).

OUTLINE:

  • Conditioning: Patients receive myeloablative or reduced-intensity conditioning regimen according to age and prior treatment.

    • Myeloablative conditioning (pediatric patients): Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide IV over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
    • Myeloablative conditioning (adult patients 18-40 years old): Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
    • Reduced-intensity conditioning (patients over 40 and no more than 50 years old OR deemed ineligible for above myeloablative conditioning regimen due to previous treatment): Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
  • Umbilical cord blood transplantation (UCBT): All patients undergo single- or double-unit umbilical cord blood transplantation (UCBT)on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -2 to 180 followed by a tapering and mycophenolate mofetil IV or orally twice daily on days 0-100 followed by a tapering over the next 3 months. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0* and continuing until blood counts recover.

NOTE: *In adult patients receiving a reduced intensity transplant, G-CSF will be started when the total white cell count falls below 2.5 x 109/L.

After completion of study treatment, patients are followed monthly for 1 year and then every 2-4 months thereafter.

02

Conditions studied

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes

Keywords

  • graft versus host disease
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • blastic phase chronic myelogenous leukemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • nodal marginal zone B-cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult non-Hodgkin lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • previously treated myelodysplastic syndromes
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • refractory multiple myeloma
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III multiple myeloma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
  • Philadelphia chromosome positive childhood precursor acute lymphoblastic leukemia
  • refractory chronic lymphocytic leukemia
  • childhood myelodysplastic syndromes
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent adult T-cell leukemia/lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

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

04

Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patient and UCB Unit Selection:

Inclusion Criteria: General (Adults and Pediatrics)

Only one of the following should be present:

  • Acute leukemia (lymphocytic or myeloid or undifferentiated or biphenotypic) in complete remission 2 or beyond
  • Acute lymphocytic leukemia, Philadelphia chromosome positive in complete remission 1 or beyond
  • Acute myeloid leukemia in complete remission 1 if it has evolved from a myeloproliferative disorder (MPD) or myelodysplastic syndrome (MDS).
  • Acute leukemia in complete remission 1 if there is a failure to recover normal blood counts or the development of MDS following induction chemotherapy.
  • Therapy related acute leukemia in complete remission 1 or beyond
  • Chronic myeloid leukemia (CML) chronic phase-1 (imatinib failures, imatinib intolerance), or any CML beyond first chronic phase
  • Myelodysplastic syndromes (Intermediate -1 or higher risk by IPSS)
  • Therapy related MDS (irrespective of IPSS)
  • Multiple myeloma must have had prior chemotherapy or autologous transplant
  • Chronic lymphocytic leukemia must have failed two lines of conventional therapy but still chemosensitive to third line therapy.
  • Chemosensitive Non-Hodgkin's lymphoma or Hodgkin's lymphoma in CR or PR after failing induction therapy.
  • High risk acute leukemia/lymphoma eg Nk/T cell, HTLV associated leukemia/lymphoma, other T cell lymphoma/leukemia in first best response
  • For patients with acute leukemia-they must be in a remission (less than 5% leukemic marrow blasts) at time of study entry.

Inclusion Criteria (Adults - 18 years or older)

  • Karnofsky score of > 70%
  • Estimated creatinine clearance of > 60 ml/min
  • Left ventricular ejection fraction of >50%
  • Pulmonary function test with DLCO, FEV1 and FVC of >60%
  • Total bilirubin and SGOT of \< 3.0 x upper limits of normal
  • Note: Age 18- 40 years for adult myeloablative conditioning Age > 40 -50 years for adult reduced intensity conditioning

Inclusion Criteria (Pediatrics - 18 years and younger)

  • Karnofsky or Lansky score of > 70%
  • Estimated Creatinine clearance of > 60 ml/min
  • Left ventricular ejection fraction of >50%
  • Pulmonary function test with FEV1 and FVC of >60% (for patients >6 years of age)
  • Total bilirubin and SGOT of \< 3.0 x upper limits of normal
  • Note: All pediatric patients will receive myeloablative conditioning

Inclusion Criteria - Donor Issues

  • No available HLA identical or 1 antigen/allele mismatched (Class I-A, B or Class II DR locus) related donor

Inclusion Criteria: Umbilical Cord Blood Unit-HLA Typing

  • At least a HLA 4/6 match (Class I-A, B by low resolution, Class II-DR by high resolution) to recipient
  • For double UCB SCT each unit should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to recipient, and should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to each other

Inclusion Criteria: Umbilical Cord Blood Unit-Cell dose

  • For Single UCB SCT: the unit will have ≥ 3.5 X 107 NC/kg of recipient body weight (For pediatric patients a cell dose ≥ 3.0 X 107 NC/kg of recipient body weight is acceptable). Recipient body weight will be determined as per standard guidelines.
  • For Double UCB SCT: (done only if no single UCB unit ≥ 3.5 X 107 NC/kg of recipient body weight is available for adults, and ≥ 3.0 X 107 NC/kg of recipient body weight is available for pediatric patients )
  • The larger of the two units (UCB1) will have a minimum cell dose of 2.0 X 107 NC/kg of recipient body weight. The smaller of the two units (UCB2) will have a minimum of 0.5 X 107 NC/kg of recipient body weight.

The total cell dose UCB1 + UCB2 will be ≥ 2.5 X 107 NC/kg of recipient body weight.

-Adult patients eligible for a double UCB SCT but without an appropriate second UCB unit will be enrolled in the study if their single UCB unit contains ≥ 2.5 x 107 NC/kg recipient body weight.

Exclusion Criteria

  • Organ dysfunction as per standard guidelines. Unable to give informed consent (for adults only)
  • Pregnant or lactating
  • Sexually active individuals capable of becoming pregnant or causing a pregnancy who are unable or unwilling to use appropriate contraceptives.
  • Active use of illicit drugs as evidenced by a positive toxicology screen for a substance not prescribed by a medical professional just prior to initiating the preparative regimen
  • Actively smoking as evidenced by a positive nicotine screen just prior to initiating the preparative regimen
  • HIV positive
  • Patients with other unrelated malignancies will be excluded except:
  • diagnosis of skin cancer (squamous cell or basal cell)
  • diagnosis of cervical dysplasia (CIN I-III)
  • any other malignancy which is currently in remission and was treated with curative intent more than 5 years preceding study entry
  • In patients with secondary MDS or secondary acute leukemias-the previous non-hematopoietic neoplasm should be in remission but can be within 5 years of study entry
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Pediatric Myeloablative conditioning

    Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide IV over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.

    Biological: anti-thymocyte globulin · Drug: cyclophosphamide · Drug: methylprednisolone · Radiation: total-body irradiation

  • Experimental
    Adult Myeloablative conditioning

    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.

    Drug: cyclophosphamide · Drug: fludarabine phosphate · Radiation: total-body irradiation

  • Experimental
    Reduced-intensity conditioning

    Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.

    Drug: cyclophosphamide · Drug: fludarabine phosphate · Radiation: total-body irradiation

Interventions

  • Biologicalanti-thymocyte globulin

    Given IV

    Also known as: ATG

  • Drugcyclophosphamide

    Given IV

    Also known as: Cytoxin

  • Drugfludarabine phosphate

    Given IV

    Also known as: Fludara

  • Drugmethylprednisolone

    Given IV

    Also known as: Medrol

  • Radiationtotal-body irradiation

    Given daily for 1-4 days

06

What researchers measure

Primary outcomes

  1. Number of Participants With 100-day Non-relapse Mortality

    Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).

    Time frame: 100 days

Secondary outcomes

  1. Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells

    Recovery of the neutrophil portion of white blood cells and showing complete donor cells.

    Time frame: 42 days

  2. Number of Participants With Acute Graft-versus-host Disease (GVHD)

    Participants who exhibit acute GVHD.

    Time frame: 100 days

  3. Number of Participants Who Relapsed at 1 Year

    Time frame: 1 year

  4. Number of Subjects With All-cause Mortality

    Death from any cause at 100 days

    Time frame: at 100 days

  5. Overall Survival

    Overall survival at 1 year

    Time frame: 1 year

  6. Number of Participants With Chronic Graft Versus Host Disease (GVHD)

    As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement

    Time frame: 100 days

07

Results

Posted Nov 10, 2010

Participant flow

Recruitment period = 9/23/2005 through 8/15/2008

Participant flow — Overall Study
MilestonePediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Started231
Completed131
Not completed100
Withdrew: Death100

Outcome measures

PrimaryNumber of Participants With 100-day Non-relapse Mortality

Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).

Time frame:
100 days
Reported as:
Number · participants
Number of Participants With 100-day Non-relapse Mortality
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Participants With 100-day Non-relapse Mortality100
SecondaryNumber of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells

Recovery of the neutrophil portion of white blood cells and showing complete donor cells.

Time frame:
42 days
Reported as:
Number · participants
Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells11—
SecondaryNumber of Participants With Acute Graft-versus-host Disease (GVHD)

Participants who exhibit acute GVHD.

Time frame:
100 days
Reported as:
Number · participants
Number of Participants With Acute Graft-versus-host Disease (GVHD)
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Participants With Acute Graft-versus-host Disease (GVHD)010
SecondaryNumber of Participants Who Relapsed at 1 Year
Time frame:
1 year
Reported as:
Number · participants
Number of Participants Who Relapsed at 1 Year
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Participants Who Relapsed at 1 Year000
SecondaryNumber of Subjects With All-cause Mortality

Death from any cause at 100 days

Time frame:
at 100 days
Reported as:
Number · participants
Number of Subjects With All-cause Mortality
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Subjects With All-cause Mortality100
SecondaryOverall Survival

Overall survival at 1 year

Time frame:
1 year
Reported as:
Number · participants
Overall Survival
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Overall Survival131
SecondaryNumber of Participants With Chronic Graft Versus Host Disease (GVHD)

As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement

Time frame:
100 days
Reported as:
Number · participants
Number of Participants With Chronic Graft Versus Host Disease (GVHD)
participantsPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
Number of Participants With Chronic Graft Versus Host Disease (GVHD)000

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pediatric Myeloablative Conditioning—0/2 (0%)0/2 (0%)
Adult Myeloablative Conditioning—1/3 (33.3%)2/3 (66.7%)
Reduced-intensity Conditioning—0/1 (0%)0/1 (0%)
Most frequent serious events
Most frequent serious events
EventPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
MRSEInfections and infestations0/21/30/1
Gram negative rods septicemiaInfections and infestations0/21/30/1
Most frequent other events
Showing 10 of 34
Most frequent other events
EventPediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity Conditioning
AnorexiaMetabolism and nutrition disorders0/22/30/1
Mucositis (functional/symptomatic)Gastrointestinal disorders0/22/30/1
Mucositis (clinical exam)Gastrointestinal disorders0/22/30/1
Catheter-related infection Grade 3-4 neutrophils (ANC < 1.0 x 10e9/L)Infections and infestations0/22/30/1
Infection with normal ANC or Grade 1-2 neutrophilsInfections and infestations0/22/30/1
HyperglycemiaMetabolism and nutrition disorders0/22/30/1
HyponatremiaMetabolism and nutrition disorders0/22/30/1
CystitisRenal and urinary disorders0/22/30/1
Infection with grade 3-4 neutrophils (ANC< 1.0 x 10e9/L)Infections and infestations0/21/30/1
Bladder infectionInfections and infestations0/21/30/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity ConditioningTotal
<=18 years2002
Between 18 and 65 years0314
>=65 years0000
Age, Continuous
Age, Continuous(years)Pediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity ConditioningTotal
Mean8 ± 131 ± 142 ± 131 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)Pediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity ConditioningTotal
Female1113
Male1203
Region of Enrollment
Region of Enrollment(participants)Pediatric Myeloablative ConditioningAdult Myeloablative ConditioningReduced-intensity ConditioningTotal
United States2316
08

Study locations

4 sites
  • Vanderbilt-Ingram Cancer Center - Cool Springs
    Nashville, Tennessee 37067-1631, United States
  • Vanderbilt-Ingram Cancer Center at Franklin
    Nashville, Tennessee 37067-5615, United States
  • Veterans Affairs Medical Center - Nashville
    Nashville, Tennessee 37212, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00608517
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Brian Engelhardt, MD (Assistant Professor of Medicine; Hematologist/Oncologist, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
Feb 6, 2008
Start date
Sep 2005
Primary completion
Mar 2008
Completion
May 2011
Results posted
Nov 10, 2010
Last update
May 20, 2014

Study contacts

Brian Engelhardt, MD
study chair · Vanderbilt-Ingram Cancer Center

Oversight

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

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This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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