Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Syndrome

Lymphoma

Leukemia

Hematologic Neoplasms

Anemia

Anemia, Aplastic

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Hemoglobinuria

Hemoglobinuria, Paroxysmal

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Myeloproliferative Disorders

Bone Marrow Diseases

Proteinuria

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urological Manifestations

Bone Marrow Failure Disorders

Pancytopenia

Hemolysis

Anemia, Hemolytic

Lymphosarcoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Busulfan

Alemtuzumab

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Three drug regimen using busulfan, and melphalan, and alemtuzumab.

intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).

intravenous melphalan 100 mg/m2 on day -3.

intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.

busulfan, and melphalan, and alemtuzumab

Andrew M Yeager, MD

The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States

A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States

To determine the efficacy of related or unrelated allogeneic PBSC transplantation (PBSCT) using a preparative regimen of busulfan, melphalan and alemtuzumab, as measured by durable donor lymphohematopoietic cell engraftment. The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).

To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.

University of Arizona

Three drug regimen using busulfan, and melphalan, and alemtuzumab.

Busulfan, and melphalan, and alemtuzumab: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).

Intravenous melphalan 100 mg/m2 on day -3.

Intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.

Busulfan, and Melphalan, and Alemtuzumab

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Program Coordinator

Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment

Number of Participants With Presence of Donor Lymphohematopoietic Chimerism (Defined as at Least 50% Donor Cells in the Peripheral Blood) in Peripheral Blood by Day +100 (i.e., 100 Days After Allogeneic PBSCT).

Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment.

Number of Participants With Relapse-free Survival.

Number of Participants With Event-free Survival.

Number of Participants With Overall Survival.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States	NCT00997386	Hematologic Neo... Multiple Myelom... Anemia, Aplasti... Hemoglobinuria,... Myelofibrosis	busulfan, and m...	18 Years - 75 Years	University of Arizona
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States	NCT00997386	Hematologic Neo... Multiple Myelom... Anemia, Aplasti... Hemoglobinuria,... Myelofibrosis	busulfan, and m...	18 Years - 75 Years	University of Arizona

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