Description:
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.
Title
- Brief Title: Nonmyeloablative Allogeneic Transplant
- Official Title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
Clinical Trial IDs
- ORG STUDY ID:
IRB#13-6255
- NCT ID:
NCT01272817
Conditions
- 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
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cladribine + melphalan | Other | Cladribine + melphalan conditioning | |
TLI | Other | Total lymphoid irradiation conditioning | |
Eligibility Criteria
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
Maximum Eligible Age: | 72 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Engraftment |
Time Frame: | One year |
Safety Issue: | |
Description: | Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant. |
Secondary Outcome Measures
Measure: | Graft-versus-host disease |
Time Frame: | One year |
Safety Issue: | |
Description: | Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Scripps Health |
Trial Keywords
- Nonmyeloablative transplant
- Allogeneic transplant
- Transplant
Last Updated
December 6, 2013