Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
Condition: Hodgkin's Lymphoma; Lymphoid Leukemia; Lymphoma; Leukemia; Myeloma; Acute Lymphocytic Leukemia; Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma; Chronic Myelogenous Leukemia; Myelodysplastic Syndromes; Recurrent Acute Myeloid Leukemia, Adult; Recurrent Hodgkin Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Recurrence
Intervention: mycophenolate mofetil; Sargramostim; Filgrastim
Intervention description: Given PO, by mouth, orally or IV, intravenous medication administration.; GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis.
Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF.; G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.
Intervention MeSH terms: Mycophenolic Acid; Molgramostim; Lenograstim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Donor Type (Matched Related Donor or Matched Unrelated Donor)

Summary:

      Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients
      receiving the investigational regimen.This is a randomized phase II clinical trial, comparing
      two different dosing schedules of mycophenolate mofetil for graft versus host disease (GVHD)
      prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and
      non-relapse mortality will be assessed. Adaptive randomization between two study arms will be
      performed based on T cell counts at day 60.
    

Eligibility criteria:

        Inclusion Criteria

          -  Any of the following high risk or recurrent hematological malignancies:

          -  Hodgkin lymphoma (HL)

          -  Non-Hodgkin lymphoma (NHL)

          -  Chronic lymphocytic leukemia (CLL)

          -  Multiple myeloma (MM)

          -  Acute myelogenous leukemia (AML)

          -  Acute lymphocytic leukemia (ALL)

          -  Chronic myelogenous leukemia (CML)

          -  Myelodysplastic syndrome (MDS)

             *Note: Determination that the malignancy is high risk will be made by the
             investigator.

          -  Investigator determination that the patient is an appropriate candidate for reduced
             intensity allogeneic SCT with the standard Massey Cancer Center-Virginia Commonwealth
             Health System Bone Marrow Transplant Massey Cancer Center Virginia Commonwealth
             University Health System Bone Marrow Transplant (MCC-VCUHS BMT) Program regimen
             employed in this trial

          -  Patients with or without previous myeloablative autologous transplant

          -  HLA-matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated
             (8/8 or 7/8 loci matched)

             *Note: Unrelated donors must be matched at HLA-A, -B, -C, and -DRB1 loci. However, a
             single locus mismatch will be acceptable in the event a more closely matched donor is
             not available.

          -  Age ≥ 40 to < 75 years; patients 18 to 39 years of age will be eligible only if the
             investigator has determined that the patient has comorbidity(ies) precluding
             conventional allogeneic transplantation with full intensity myeloablative conditioning

          -  Karnofsky Performance Status of 70-100%

          -  Negative serology for HIV

          -  Women who are not postmenopausal or have not undergone hysterectomy must have a
             documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines

          -  Ability to understand and the willingness to sign a written informed consent document
             *Note: The consent form must be signed and dated prior to initiation of SCT
             preparative treatments.

        Exclusion Criteria

          -  Previous therapeutic radiation therapy (RT) that exceeds critical structure tolerance
             doses as determined by a radiation oncologist

          -  Uncontrolled viral, fungal, or bacterial infection

          -  Active meningeal or central nervous system disease

          -  Previous therapy with rabbit anti-thymocyte globulin (ATG); previous treatment with
             equine ATG is allowed if more than 3 months ago

             *Note: Previous myeloablative autologous transplant is permitted but not required.

          -  Pregnancy or breastfeeding

          -  Medical, psychological, or social condition that, in the opinion of the investigator,
             may increase the patient's risk or limit the patient's adherence with study
             requirements