Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma
Condition: Mantle Cell Lymphoma; Diffuse Large Cell Lymphoma; Burkitts Lymphoma; T Cell Lymphomas; Acute Myeloid Leukemia/Acute Lymphoblastic Leukemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: cellular immunotherapy
Intervention description: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Lymphoma; Mantle cell; DLBCL; DLBC; Diffuse large B cell; T cell; AML; ALL

Summary:

      The study of whether an infusion of blood cells called lymphocytes from a donor can stimulate
      the immune system to fight your leukemia/lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of hematological malignancy consisting of the following
             leukemias/lymphomas:

          -  Mantle cell lymphoma with Ki-67>30%

          -  Diffuse Large Cell Lymphoma

          -  Burkitts Lymphoma

          -  Systemic T Cell Lymphomas

          -  Acute Myeloid Leukemia

          -  Acute Lymphoblastic Leukemia

          -  Recurrence or progression of hematological malignancy after at least 1 prior standard
             treatment with progression within 6 months from last treatment.

          -  No curative treatment option is available.

             -> 4-weeks since prior chemotherapy or radiation to cellular therapy infusion.
             (Hydroxyurea may be utilized up to 48 hours prior to initiation of treatment on this
             protocol).

          -  Age equal to or greater than 18 years.

          -  Patients with a history of invasive second malignancy unless disease free for > 5
             years.

          -  Patients must have an expected life expectancy of at least 2 months at the time of
             initiation of treatment.

          -  No active systemic infection.

          -  Patients who have relapsed after standard autologous stem cell infusion are eligible
             as long as they meet all inclusion criteria and no exclusion criteria. These patients
             must be out more than 6 months from cell infusion to be eligible for enrollment.

          -  DLCO > 40% with no symptomatic pulmonary disease.

          -  LVEF > 40% by MUGA or echocardiogram.

          -  Creatinine < 2.0 mg/dl. Total bilirubin less than 1.5x the upper limit of normal
             (ULN), AST < 3x ULN.

          -  Non-pregnant and willing to use appropriate birth control during the duration of the
             study period.

        Exclusion Criteria:

          -  Evidence of HIV infection.

          -  Any uncontrolled severe, concurrent illness which in the opinion of the treating
             physician would make this protocol treatment unreasonably hazardous for the patient.

          -  Oxygen dependent obstructive pulmonary disease.

          -  Failure to demonstrate adequate compliance with medical therapy and follow-up.

          -  Significant medical or psychiatric illness that would impair the ability to
             participate in protocol therapy.

          -  For women of reproductive potential, refusal to use effective form of contraception.

          -  Previous allogeneic stem cell transplant

          -  Patients who have had previous purine analog (fludarabine, pentostatin, 2-CDA)
             -Patients with chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL),
             multiple myeloma, and indolent lymphoma (follicular lymphoma, marginal zone lymphoma)

          -  Patients with HLA antibodies to donor HLA type.