Nonmyeloablative Allogeneic Transplant

Study Overview
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Brief Summary
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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
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same

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

Conditions
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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

Intervention / Treatment
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* Procedure: Nonmyeloablative Allogeneic Transplant
* Procedure: Nonmyeloablative Allogeneic Transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cladribine + melphalan<br>Cladribine + melphalan conditioning | Procedure: Nonmyeloablative Allogeneic Transplant<br>* Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day<br>|
| Other: TLI<br>Total lymphoid irradiation conditioning | Procedure: Nonmyeloablative Allogeneic Transplant<br>* Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment | Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft-versus-host disease | Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonmyeloablative transplant, Allogeneic transplant, Transplant