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Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies


Phase 2
N/A
70 Years
Open (Enrolling)
Both
Blood Cancer, Leukemia

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Trial Information

Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies


Inclusion Criteria:



(A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom
allogeneic NST is warranted. Specific disease categories include: indolent advanced stage
Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin
Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxysmal Nocturnal
Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other
selected malignancies/disorders may also be considered but must be approved by the
transplant team and the Principal Investigator.

(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing
medical conditions or prior therapy are considered to be at high risk for regimen-related
toxicity associated with conventional myeloablative transplants.

(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with
one antigen mismatched donors can be considered but only after discussion with the
transplant team and the Principal Investigator.

(D) Patient must be competent to give consent.

Exclusion Criteria:

(A) Patients with progressive hematolymphoid malignancies despite conventional therapies,
or acute leukemias not in complete remission.

(B) Uncontrolled CNS involvement with disease

(C) Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment

(D) Females who are pregnant

(E) Organ dysfunction defined as follows:

- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure

- Pulmonary: DLCO <40% predicted

- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or
transaminases >4x the upper limit of normal

- Renal: creatinine clearance <50 cc/min (24 hour urine collection)

(F) Karnofsky performance score < 60%

(G) Patients with poorly controlled hypertension on multiple antihypertensives

(H) Documented fungal disease that is progressive despite treatment

(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be
evaluated on a case by case basis

(J) 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Unknown

Safety Issue:

Yes

Principal Investigator

Robert Lowsky

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT153

NCT ID:

NCT00185640

Start Date:

March 2003

Completion Date:

June 2016

Related Keywords:

  • Blood Cancer
  • Leukemia
  • Leukemia
  • Hematologic Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317