Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath
Condition: Lymphoma; Myeloma; Leukemia; Myelodysplasia; Solid Tumors
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Campath Purged Non-myeloablative ASCT
Intervention description: Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.
Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
Intervention MeSH terms: Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Allogeneic Stem Cell Transplantation, Campath, HLA-Matched

Summary:

      Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though
      the potential toxicities of the procedure remain high. We and others have shown that a less
      toxic preparative regimen allows reliable allogeneic engraftment for allogeneic
      transplantation.

      The primary purpose of this treatment trial is to follow subjects undergoing allogeneic
      transplantation for long term outcomes. The regimen used has been tested in our prior phase I
      / II trial which has completed accrual. The issues of engraftment and rate of graft versus
      host disease have been answered and our success has led to this regimen being a standard
      approach for less toxic allogeneic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have their pathology reviewed and the diagnosis confirmed.

          -  Performance status must be Cancer and Leukemia Group B (CALGB) performance score 0, 1,
             or 2

          -  Subjects must have a 6/6 Human leukocyte antigen (HLA)-matched related donor who is
             evaluated and deemed able to provide peripheral blood progenitor cells (PBPC) and/or
             marrow by the transplant team.

          -  HIV antibody negative.

          -  Subjects must test negative serum beta-human chorionic gonadotropin (HCG) and must
             agree to use some form of adequate birth control during the periods they receive
             chemotherapy and any post-chemotherapy medications related to the transplant.

          -  Subjects must be >/=17 years of age

          -  Subjects must also have a resting multigated acquisition (MUGA) and/or ECHO and
             pulmonary function test (PFT) with diffusion capacity of lung (DLCO) performed before
             transplant and found to be acceptable according to the treating institution's
             guidelines. The required minimum standards include MUGA and/or ECHO showing an
             ejection fraction (EF) of 40% and PFTs showing DLCO of 40%. Those with an EF 40-50%,
             undergo cardiac evaluation and consultation. Also, those with DLCO 40-50%, undergo
             pulmonary evaluation and consultation.

          -  Specific populations for each disease category:

        A) Hematologic malignancies Those with high risk or relapsed hematologic malignancy
        (including myeloid and lymphoid leukemias and lymphomas, myeloma or myelomatous like
        diseases, myeloproliferative disease, myelodysplasia). Those with good risk disease (first
        remission acute myeloid leukemia (AML) with inv 16 M4 Eos, M3 AML with t(15;17); or t(8;21)
        in first remission are not eligible).

        B) Bone marrow failure

          1. Those specifically with idiopathic or secondary moderate, severe or very severe
             aplastic anemia (idiopathic or secondary) according to the accepted 'Camitta criteria'
             would be candidates.

          2. Those with diseases known to lead to severe marrow failure are eligible as well. These
             include those with myelofibrosis or paroxysmal nocturnal hemoglobinuria (PNH).

        C) Solid Tumors Subjects must have had a biopsy confirming disease recurrence (metastases)
        at some point in their history, unless the patient presented with metastatic disease, in
        which case the initial primary site biopsy is adequate.

          1. Subjects with renal cell cancer, or melanoma will be eligible for this approach at
             this time. Subjects will have had documented metastatic disease at some time in the
             past. Subjects who are in remission or with residual disease after prior therapy for
             their metastatic disease are eligible, as there is no accepted cure for these patients
             with metastatic disease.

          2. Breast Cancer- Subjects will have had documented metastatic disease at some time in
             the past. Subjects who are in remission or with residual disease after prior therapy
             for their metastatic disease are eligible. Subjects must have failed at least one
             chemotherapy regimen for their metastatic disease and 1 hormonal agent if they are
             receptor positive.

        Exclusion Criteria:

          1. pregnant or lactating women,

          2. patients with other major medical or psychiatric illnesses which the treating
             physician feels could seriously compromise tolerance to this protocol, and

          3. Leukemia patients in first remission with good risk cytogenetics for leukemia
             [t(15;17); t(8,22)]