We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185640
First Posted: September 16, 2005
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Lowsky, Stanford University
September 12, 2005
September 16, 2005
December 1, 2016
October 3, 2017
October 3, 2017
March 2003
April 2014   (Final data collection date for primary outcome measure)
Acute Graft vs Host Disease (GvHD) [ Time Frame: 100 days post-transplant ]

The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.

Skin manifestations Skin Stages

  • 0: No rash
  • 1: Maculopapular (MP) rash <25% of body surface area
  • 2: MP rash on 25-50% of body surface area
  • 3: Generalized erythroderma (ED)
  • 4: Generalized ED with bullous formation and desquamation

Liver Stages (Bilirubin in mg/dL)

  • 0: <2
  • 1: 2-3
  • 2: 3.01-6
  • 3: 6.01-15.0
  • 4: >15

Gastrointestinal (GI) Stages (diarrhea)

  • 0: None or < 500 mL/day
  • 1: 500-999 mL/day
  • 2: 1000-1499 mL/day
  • 3: >1500 mL/day
  • 4: Severe abdominal pain, with or without ileus

Glucksberg Overall grade

  • Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.
  • Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
  • Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
  • Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
Not Provided
Complete list of historical versions of study NCT00185640 on ClinicalTrials.gov Archive Site
  • Acute Graft vs Host Disease (GvHD), All Evaluable [ Time Frame: 100 days post-transplant ]

    The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.

    Skin manifestations Skin Stages

    • 0: No rash
    • 1: Maculopapular (MP) rash <25% of body surface area
    • 2: MP rash on 25-50% of body surface area
    • 3: Generalized erythroderma (ED)
    • 4: Generalized ED with bullous formation and desquamation

    Liver Stages (Bilirubin in mg/dL)

    • 0: <2
    • 1: 2-3
    • 2: 3.01-6
    • 3: 6.01-15.0
    • 4: >15

    Gastrointestinal (GI) Stages (diarrhea)

    • 0: None or < 500 mL/day
    • 1: 500-999 mL/day
    • 2: 1000-1499 mL/day
    • 3: >1500 mL/day
    • 4: Severe abdominal pain, with or without ileus

    Glucksberg Overall grade

    • Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.
    • Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80
    • Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60
    • Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40
  • Incidence of Relapse [ Time Frame: 3 years ]
    Reports the overall rate of disease relapse, occurring any time within 3 years after transplant
  • Overall Survival (OS) [ Time Frame: 3 and 5 years ]
  • Event-free Survival (EFS) [ Time Frame: 3 and 5 years ]
    Reports the proportion of subjects who neither died due to any cause nor experienced relapse.
  • Transplant-related Mortality [ Time Frame: 1 year ]
    Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.
Not Provided
Not Provided
Not Provided
 
Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
This study will evaluate if TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Blood Cancer
  • Leukemia
  • Drug: Cyclosporine
    starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL
    Other Names:
    • Cyclosporin
    • Cyclosporin A
  • Drug: Anti-Thymocyte Globulin
    1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT
    Other Names:
    • Thymoglobulin
    • ATG
  • Drug: mycophenolate mofetil
    Begins on day 0 after HCT at a dose of 15 mg/kg. Patients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.
    Other Names:
    • CellCept
    • MMF
  • Drug: Granulocyte-Colony Stimulating Factor
    Received on day 0
    Other Names:
    • Filgrastim
    • colony-stimulating factor 3
    • csf 3
    • G-CSF
    • GCSF
  • Radiation: Total Lymphoid Irradiation
    0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.
    Other Name: TLI
Experimental: Non-myeloablative transplantation
Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil .
Interventions:
  • Drug: Cyclosporine
  • Drug: Anti-Thymocyte Globulin
  • Drug: mycophenolate mofetil
  • Drug: Granulocyte-Colony Stimulating Factor
  • Radiation: Total Lymphoid Irradiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
January 2016
April 2014   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include:

    • Indolent advanced stage non-Hodgkin lymphomas
    • Mantle cell lymphoma
    • Chronic lymphocytic leukemia
    • Hodgkin disease (Hodgkin's lymphoma)
    • Acute leukemias in complete remission
    • Aplastic anemia
    • Paroxysmal nocturnal hemoglobinuria
    • Myelodysplastic or myeloproliferative syndromes.
    • Other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
  • Age > 50 years, or if < 50 years of age, considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy.
  • A fully human leukocyte antigen (HLA)-identical sibling or matched unrelated donor is available. Potential participants with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
  • Participant must be competent to give consent.

EXCLUSION CRITERIA:

  • Progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
  • Uncontrolled central nervous system (CNS) involvement with disease
  • Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
  • Pregnant
  • Cardiac ejection fraction < 30%
  • Uncontrolled cardiac failure
  • Pulmonary diffusing capacity (DLCO) < 40% predicted
  • Elevation of bilirubin to > 3 mg/dL
  • Transaminases > 4 x the upper limit of normal
  • Creatinine clearance < 50 cc/min (24-hour urine collection)
  • Karnofsky performance score < 60%
  • Poorly controlled hypertension on multiple antihypertensives
  • Documented fungal disease that is progressive despite treatment
  • HIV-positive. Other viral infections, ie, Hepatitis B- and C- positive, evaluated on a case-by-case basis
  • Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Sexes Eligible for Study: All
50 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00185640
IRB-11960
78998 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT153 ( Other Identifier: OnCore )
Yes
Not Provided
Plan to Share IPD: No
Robert Lowsky, Stanford University
Stanford University
Not Provided
Principal Investigator: Robert Lowsky Stanford University
Stanford University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP