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

NCT ID: NCT00997386

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hematologic Neoplasms; Multiple Myeloma; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Myelofibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

busulfan, and melphalan, and alemtuzumab

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

Group Type: EXPERIMENTAL

busulfan, and melphalan, and alemtuzumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Busulfan (Busulfex®),; Melphalan (Alkeran®); Alemtuzumab (Campath®)

Eligibility Criteria

Inclusion Criteria

• Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease.
• Subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. In other words, the subject cannot enroll in this trial for initial treatment of the disease.
• Availability of a healthy related or unrelated volunteer allogeneic donor.

Exclusion Criteria

• Eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease.
• Severe abnormal function of organs such as heart, kidneys, liver.
• Untreated or progressive central nervous system involvement by the disease.
• Subject is pregnant or breast-feeding.
• Performance score is below 50: at the least, requires considerable assistance and frequent medical care.
• Positive for the HIV [AIDS] virus
• Life expectancy less than 12 weeks with conventional treatments.
• For subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after PBSCT or after stopping post-transplant immunosuppressive treatments, whichever occurs later.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew M Yeager, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University Medical Center and UMC-North Clinic

Tucson, Arizona, United States

Countries

United States

Other Identifiers

09-0679-04

Identifier Type: -

Identifier Source: org_study_id