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Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

18 Years
72 Years
Open (Enrolling)
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

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Trial Information

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

Inclusion Criteria:

1. Age > 55 years or

2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min

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)


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Jeffrey W. Andrey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scripps Health


United States: Institutional Review Board

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • 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
  • Waldenström Macroglobulinemia
  • Breast Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Sarcoma
  • Ovarian Cancer
  • Thymoma
  • Nonmyeloablative transplant
  • Allogeneic transplant
  • Transplant
  • Anemia
  • Anemia, Aplastic
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Hemoglobinuria
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Hemoglobinuria, Paroxysmal
  • Melanoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Ovarian Neoplasms
  • Thymoma
  • Lymphoma, Mantle-Cell
  • Sarcoma



Scripps Green Hospital La Jolla, California  92037