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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2016-01-31

Brief Summary

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To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

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Detailed Description

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This study evaluated whether 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.

Conditions

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Blood Cancer Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-myeloablative transplantation

Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.

Group Type EXPERIMENTAL

Cyclosporine

Intervention Type DRUG

Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL

Anti-thymocyte globulin (ATG)

Intervention Type DRUG

1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.

Filgrastim

Intervention Type DRUG

* Donors mobilized with 16 µg/kg/day filgrastim.
* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day

Total Lymphoid Irradiation (TLI)

Intervention Type RADIATION

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.

Interventions

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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

Intervention Type DRUG

Anti-thymocyte globulin (ATG)

1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily.

Intervention Type DRUG

Filgrastim

* Donors mobilized with 16 µg/kg/day filgrastim.
* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day

Intervention Type DRUG

Total Lymphoid Irradiation (TLI)

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.

Intervention Type RADIATION

Other Intervention Names

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Cyclosporin Cyclosporin A Thymoglobulin CellCept Neupogen Granulocyte-colony stimulating factor (G-CSF; GCSF) colony-stimulating factor 3 (CSF-3)

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No