Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
Condition: Hematologic Neoplasms; Multiple Myeloma; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Myelofibrosis
MeSH terms: Multiple Myeloma; Neoplasms; Hematologic Neoplasms; Hemoglobinuria; Primary Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal
Intervention: busulfan, and melphalan, and alemtuzumab
Intervention description: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).
intravenous melphalan 100 mg/m2 on day -3.
intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.
Intervention MeSH terms: Melphalan; Busulfan; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hematologic malignancies; lymphoma, leukemia, MDS (myelodysplastic syndrome); reduced-intensity preparative regimen; allogeneic peripheral blood stem cell transplant; myelofibrosis or other myeloproliferative syndromes

Summary:

      The purpose of this study is to look at whether the combination of lower-dose chemotherapy
      with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody
      medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so
      that those cells take hold and build a healthy new blood cell factory after transplant. The
      study will also look at the safety of the combination of drugs and of the transplant of
      peripheral blood stem cells from a healthy relative or an unrelated donor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior
             autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in
             first complete remission or first chronic phase; and/or presence of one or more
             medical conditions that would place the subject at high risk such as heart and kidney
             disease.

          -  Subjects with hematologic cancers must have received at least one previous course of
             chemotherapy or biological therapy. In other words, the subject cannot enroll in this
             trial for initial treatment of the disease.

          -  Availability of a healthy related or unrelated volunteer allogeneic donor.

        Exclusion Criteria:

          -  Eligible for another study or standard of care treatment that offers higher
             probability of cure or long-term control of subject's disease.

          -  Severe abnormal function of organs such as heart, kidneys, liver.

          -  Untreated or progressive central nervous system involvement by the disease.

          -  Subject is pregnant or breast-feeding.

          -  Performance score is below 50: at the least, requires considerable assistance and
             frequent medical care.

          -  Positive for the HIV [AIDS] virus

          -  Life expectancy less than 12 weeks with conventional treatments.

          -  For subjects capable of having children, refusal to practice birth control while on
             this study and for at least 12 months after PBSCT or after stopping post-transplant
             immunosuppressive treatments, whichever occurs later.