Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies

• To evaluate the incidence and extent of chronic GVHD. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
• To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
• To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
• To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. [ Time Frame: Unknown ] [ Designated as safety issue: No ]

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

• Blood Cancer
• Leukemia

• Drug: cyclosporine
  3-5 mg/kg BID; IV or oral
  Other Names:

  • cyclosporin
  • cyclosporin A
• Drug: Thymoglobulin
  7.5-10 mg/kg; IV
  Other Name: Anti-thymocyte globulin
• Drug: mycophenolate mofetil
  15 mg/kg BID or Q 8 hours
  Other Names:

  • MMF
  • CellCept
• Drug: g-csf
  16 mcg/kg; SQ
  Other Names:

  • Granulocyte colony-stimulating factor
  • gcsf
  • colony-stimulating factor 3
  • csf 3

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.