Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Aplastic Anemia, Breast Cancer, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Lymphoma, Mantle Cell Lymphoma, Melanoma, Multiple Myeloma, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma, Ovarian Cancer, Paroxysmal Nocturnal Hemoglobinuria, Renal Cell Carcinoma, Sarcoma, Thymoma, Waldenstrom Macroglobulinemia
Conditions
Keywords
Nonmyeloablative transplant, Allogeneic transplant, Transplant
Brief 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.
Detailed description
same
Interventions
PROCEDURENonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Sponsors
Scripps Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engraftment | One year | Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft-versus-host disease | One year | Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol. |
Countries
United States
Outcome results
None listed