Breast Cancer Clinical Trial

Nonmyeloablative Allogeneic Transplant

Summary

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.

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Eligibility Criteria

Inclusion Criteria:

Age > 55 years or
Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
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:

Prior allogeneic stem cell or bone marrow transplant
Current or past history of invasive mycotic infection
Breast Feeding

Study is for people with:

Breast Cancer

Estimated Enrollment:

36

Study ID:

NCT01272817

Recruitment Status:

Completed

Sponsor:

Scripps Health

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There is 1 Location for this study

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Scripps Green Hospital
La Jolla California, 92037, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

36

Study ID:

NCT01272817

Recruitment Status:

Completed

Sponsor:


Scripps Health

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