Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Condition: Leukemia
MeSH terms: Hematologic Neoplasms
Intervention: allogeneic hematopoietic stem cell transplantation; CliniMACS
Intervention description: Undergo allogeneic hematopoietic stem cell transplant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: CliniMACS-CD34 Reagent System; Acute Leukemia; Myelodysplastic syndrome; Non Hodgkins Lymphoma; Hodgkins Disease; Multiple Myeloma; 12-016

Summary:

      The purpose of this study is to find out if getting a blood stem cell transplant with donor
      stem cells given over several days is better than getting a blood stem cell transplant with
      donor stem cells given over 1 day. We want to find out which procedure over will result in
      improved recovery of blood and immune function after transplant. When donor stem cells are
      given over various days in mice, the blood and immune system recovery is quicker.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are considered candidates for an allogeneic stem cell transplantation as
             treatment for any of the following hematologic disorders:

          -  Acute Leukemia

          -  Myelodysplastic syndrome

          -  Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic
             leukemia, or chronic myelogenous leukemia)

          -  Non Hodgkins Lymphoma

          -  Hodgkins Disease

          -  Multiple Myeloma

          -  Age includes from birth to < 75 years old.

          -  Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > 70%

          -  Patients must have adequate organ function measured by:

          -  Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 40%

          -  Hepatic: < 5x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital
             benign hyperbilirubinemia.

          -  Renal: serum creatinine <1.5 mg/dl or if serum creatinine is outside the normal range,
             then CrCl > 40 ml/min (measured or calculated/estimated)

          -  Pulmonary: asymptomatic or if symptomatic, DLCO > 40% of predicted (corrected for
             hemoglobin).

        Exclusion Criteria:

          -  Female patients who are pregnant or breast-feeding.

          -  Active viral, bacterial or fungal infection

          -  Patient seropositive for HIV-I/II; HTLV -I/II

          -  Presence of leukemia in the CNS

          -  Candidate for a protocol of higher priority. For the purpose of this study, the
             following protocols will be considered of higher priority: 10-051

        Donor Inclusion Criteria:

          -  HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts
             or 1-2 HLA allele disparate donor for CD34 selected grafts).

          -  Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION
             FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual,
             document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm

          -  Donor must have adequate peripheral venous catheter access for leukapheresis or must
             agree to placement of a central catheter.

          -  Wt >25kg

        Donor Exclusion Criteria:

          -  Evidence of active infection (including urinary tract infection, or upper respiratory
             tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and
             HBV DNA negative.

          -  Medical or physical reason which makes the donor unlikely to tolerate or cooperate
             with growth factor therapy and leukapheresis.

          -  Factors which place the donor at increased risk for complications from leukapheresis
             or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary
             artery disease requiring therapy).

          -  Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age
             must avoid becoming pregnant while on the study