Clinical Trials /

Nonmyeloablative Allogeneic Transplant

NCT01272817

Description:

Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Breast Carcinoma
  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma
  • Ovarian Carcinoma
  • Paroxysmal Nocturnal Hemoglobinuria
  • Renal Cell Carcinoma
  • Sarcoma
  • Thymoma
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Unknown status

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Nonmyeloablative Allogeneic Transplant
  • Official Title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

Clinical Trial IDs

  • ORG STUDY ID: IRB#13-6255
  • NCT ID: NCT01272817

Conditions

  • Aplastic Anemia
  • Paroxysmal Nocturnal Hemoglobinuria
  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Myelodysplastic Syndrome
  • Chronic Myelogenous Leukemia
  • Chronic Lymphocytic Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • Waldenstrom Macroglobulinemia
  • Breast Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Sarcoma
  • Ovarian Cancer
  • Thymoma

Purpose

Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

Trial Arms

NameTypeDescriptionInterventions
Cladribine + melphalanOtherCladribine + melphalan conditioning
    TLIOtherTotal lymphoid irradiation conditioning

      Eligibility Criteria

              Inclusion Criteria:
      
                1. Age > 55 years or
      
                2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
      
                3. Ability to cover the cost of the transplant, necessary medications, and
                   transportation/housing.
      
                4. Caregiver must be available while outpatient
      
              Guidelines for Cladribine-Melphalan-based conditioning:
      
                -  Bone Marrow Failure States Severe Aplastic Anemia (relapsed following
                   immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic
                   features or hemosiderosis)
      
                -  AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second
                   induction attempt)
      
                -  ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse
                   failing reinduction attempt)
      
                -  MDS (RAEB, RAEBiT, CMMoL)
      
                -  CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd
                   chronic or accelerated phase following gleevec therapy
      
                -  Hodgkin's lymphoma (first or greater relapse)
      
                -  Non-Hodgkin's Lymphoma
      
                -  Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR
                   Sensitive or refractory relapse
      
                -  Indolent Histology Second or greater relapse
      
                -  Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
      
                -  Multiple Myeloma (10% residual plasmacytosis following anthracycline-based
                   chemotherapy or residual disease following autologous transplant)
      
                -  Waldenstrom Macroglobulinemia (must have failed either purine analogue-based
                   chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)
      
              Guidelines for total lymphoid irradiation-based conditioning
      
                -  MDS (RA, RARS)
      
                -  CLL (Rai stage III or IV - must have received at least two different treatment
                   regimens in the past)
      
                -  Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
      
                -  Renal Cell Cancer (metastatic disease at multiple sites)
      
                -  Malignant Melanoma (metastatic disease at multiple sites)
      
                -  Sarcoma (all subtypes presently, unresectable metastatic disease)
      
                -  Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within
                   6 months of initial platinum chemotherapy)
      
                -  Thymoma (unresectable disease)
      
              Exclusion Criteria:
      
                1. Prior allogeneic stem cell or bone marrow transplant
      
                2. Current or past history of invasive mycotic infection
      
                3. Breast Feeding
            
      Maximum Eligible Age:72 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Engraftment
      Time Frame:One year
      Safety Issue:
      Description:Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

      Secondary Outcome Measures

      Measure:Graft-versus-host disease
      Time Frame:One year
      Safety Issue:
      Description:Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Unknown status
      Lead Sponsor:Scripps Health

      Trial Keywords

      • Nonmyeloablative transplant
      • Allogeneic transplant
      • Transplant

      Last Updated