Clinical trial NCT01272817: Nonmyeloablative Allogeneic Transplant
Official title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Nonmyeloablative transplant
Allogeneic transplant
Transplant
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Engraftment
timeFrame: One year
Secondary outcomes:
measure: Graft-versus-host disease
timeFrame: One year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps Health
name: Jeffrey W. Andrey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: