Nonmyeloablative Allogeneic Transplant

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01272817

Run by

Scripps Health

People needed

36

Starts

2001-10-01

Expected to finish

2015-10-01

Last updated by the study team

2022-11-23

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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

Where it is running

• Scripps Green Hospital — La Jolla, California, United States

Full record on ClinicalTrials.gov

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