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


N/A
18 Years
72 Years
Open (Enrolling)
Both
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)

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Engraftment

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:

No

Principal Investigator

Jeffrey W. Andrey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scripps Health

Authority:

United States: Institutional Review Board

Study ID:

SCC-01-499

NCT ID:

NCT01272817

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

Name

Location

Scripps Green Hospital La Jolla, California  92037