Nonmyeloablative Allogeneic Transplant (Mini-allo)

Scripps Health

Status: Completed

Conditions: Breast Cancer; Waldenstrom Macroglobulinemia; Melanoma; Acute Myelogenous Leukemia; Mantle Cell Lymphoma; Chronic Myelogenous Leukemia; Ovarian Cancer; Thymoma; Hodgkin's Lymphoma; Acute Lymphocytic Leukemia; Sarcoma; Multiple Myeloma; Paroxysmal Nocturnal Hemoglobinuria; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Renal Cell Carcinoma; Myelodysplastic Syndrome; Aplastic Anemia

Treatments: Procedure: Nonmyeloablative Allogeneic Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT01272817

IRB#13-6255

Details and patient eligibility

About

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.

Full description

same

Enrollment: 36 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Cladribine + melphalan

Other group

Description:

Cladribine + melphalan conditioning

Treatment:

Procedure: Nonmyeloablative Allogeneic Transplant

Procedure: Nonmyeloablative Allogeneic Transplant

TLI

Other group

Description:

Total lymphoid irradiation conditioning

Treatment:

Procedure: Nonmyeloablative Allogeneic Transplant

Procedure: Nonmyeloablative Allogeneic Transplant