- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997386
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States (ALBUM)
September 5, 2019 updated by: University of Arizona
A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85719
- University Medical Center and UMC-North Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: busulfan, and melphalan, and alemtuzumab
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: Day +100
|
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).
|
Day +100
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Relapse-free Survival.
Time Frame: Day +100
|
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.
|
Day +100
|
Number of Participants With Event-free Survival.
Time Frame: Day +100
|
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.
|
Day +100
|
Number of Participants With Overall Survival.
Time Frame: Day +100
|
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.
|
Day +100
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew M Yeager, MD, University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
October 15, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (Estimate)
October 19, 2009
Study Record Updates
Last Update Posted (Actual)
September 9, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms by Site
- Urologic Diseases
- Urological Manifestations
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Urination Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Anemia
- Neoplasms, Plasma Cell
- Proteinuria
- Anemia, Hemolytic
- Bone Marrow Failure Disorders
- Myelodysplastic Syndromes
- Neoplasms
- Hematologic Neoplasms
- Primary Myelofibrosis
- Multiple Myeloma
- Anemia, Aplastic
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Melphalan
- Busulfan
- Alemtuzumab
Other Study ID Numbers
- 09-0679-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematologic Neoplasms
-
St. Jude Children's Research HospitalRecruitingRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
-
Epizyme, Inc.WithdrawnRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHematologic MalignancyChina
-
Innovent Biologics (Suzhou) Co. Ltd.Recruiting
-
Massachusetts General HospitalRecruiting
-
Fondazione EMN Italy OnlusCompletedHEMATOLOGIC MALIGNANCIESItaly
-
Center for International Blood and Marrow Transplant...National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedHematologic MalignancyUnited States
-
Rigshospitalet, DenmarkNovo Nordisk A/SCompletedHematologic MalignancyDenmark
-
SecuraBioCompletedHematologic MalignancyUnited States, Italy
-
Duke UniversityActive, not recruitingHematologic MalignancyUnited States
Clinical Trials on busulfan, and melphalan, and alemtuzumab
-
Fundacion Para La Investigacion Hospital La FeUnknown
-
Ruijin HospitalRecruitingMyelodysplastic Syndromes | Myelodysplastic Syndrome With Excess Blasts-2 | Myelodysplastic Syndrome With Excess Blasts-1China
-
Shanghai Jiao Tong University School of MedicineRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesChina
-
University of Illinois at ChicagoCompletedAcute Myeloid Leukemia | Polycythemia Vera | Multiple Myeloma | Myelofibrosis | Acute Leukemia | Chronic Myelogenous Leukemia | Aplastic Anemia | Myeloproliferative Disorder | Hodgkin's Disease | Malignant Lymphoma | Lymphocytic LeukemiaUnited States
-
Vastra Gotaland RegionRecruitingStem Cell Transplantation | Acute Myeloid Leukemia (AML) in RemissionBelgium, Denmark, Finland, Hong Kong, Israel, Lithuania, Netherlands, Norway, Spain, Sweden
-
Washington University School of MedicineRecruitingSevere Combined Immunodeficiency | Chronic Granulomatous Disease | DiGeorge Syndrome | Hemophagocytic Lymphohistiocytosis | Wiskott-Aldrich Syndrome | X-linked Lymphoproliferative Syndrome | X-linked Agammaglobulinemia | Chediak-Higashi Syndrome | IPEX | Autoimmune Lymphoproliferative Syndrome | Common Variable... and other conditionsUnited States
-
Washington University School of MedicineHealthCore-NERI; Pediatric Blood and Marrow Transplant ConsortiumCompletedSevere ThalassemiaUnited States
-
Zou DehuiJuventas Cell Therapy Ltd.Active, not recruitingLarge B-cell LymphomaChina
-
Loyola UniversityAmgenRecruiting
-
The First Affiliated Hospital of Soochow UniversityRecruitingHematopoietic Stem Cell Transplantation | Relapse/Recurrence | Hematopoietic MalignancyChina