T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cytarabine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• One of the following diagnoses:

• Acute myelogenous leukemia (AML) meeting 1 of the following conditions:

• Failed to achieve first remission after an intensive induction regimen containing an anthracycline and cytarabine

• In second remission and not enrolled in a protocol for autologous bone marrow transplantation

• Failed to achieve or sustain second remission

• In first remission but at high risk of relapse because of 1 of the following factors:

• High-risk cytogenetic features (monosomy 7,5q-, trisomy 8, or t(9;22))

• AML secondary to treatment of a prior malignancy and without good-risk cytogenetic features of t(8;21), t(15;17), or inv 16

• AML secondary to myelodysplastic disease

• Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:

• In second remission with initial relapse occurring within 2 years of diagnosis

• In first complete remission with high-risk cytogenetics (t(9;22) or t(4;11))

• In third or subsequent remission

• Failed to achieve or sustain a second remission

• Chronic myelogenous leukemia (CML) in first or second chronic phase or accelerated phase

• Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve a remission within the first 4 weeks of induction therapy

• Juvenile CML

• Myelodysplastic syndrome

• Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine

• No CNS or skin involvement with leukemia

• No requirement for mediastinal irradiation

• No healthy, HLA-identical related donor of at least 1 year of age or matched unrelated donor available within 4-6 months

• Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor

• Willing and able to undergo general anesthesia for marrow donation and a 5-day course of filgrastim (G-CSF) with 2 daily leukaphereses

PATIENT CHARACTERISTICS:

Age:

• Under 50 (50 and over allowed on a case-by-case basis)

Performance status:

• Age 16 and over:

• Karnofsky 70-100%

• Under age 16:

• Lansky 50-100%

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2.0 mg/dL (in the absence of liver involvement)

• AST less than twice normal (in the absence of liver involvement)

Renal:

• Creatinine normal OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise

Pulmonary:

• Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin)

Other:

• No known hypersensitivity to mouse protein or chicken egg products

• No active viral, bacterial, or fungal infection

• HIV-1, HIV-2, HTLV-1, and HTLV-2 negative

• No other concurrent medical condition that would preclude transplantation

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics