Mini-allo: Nonmyeloablative Allogeneic Transplant

Sponsor

Scripps Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT01272817

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Nonmyeloablative Allogeneic Transplant Procedure: Nonmyeloablative Allogeneic Transplant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2001

Anticipated Primary Completion Date :

Jan 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Cladribine + melphalan

Cladribine + melphalan conditioning

Procedure: Nonmyeloablative Allogeneic Transplant

Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day

Other: TLI

Total lymphoid irradiation conditioning

Procedure: Nonmyeloablative Allogeneic Transplant

Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)

Outcome Measures

Primary Outcome Measures

Engraftment [One year]
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.

Secondary Outcome Measures

Graft-versus-host disease [One year]
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)