Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997386
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : December 24, 2018
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Multiple Myeloma Anemia, Aplastic Hemoglobinuria, Paroxysmal Myelofibrosis Drug: busulfan, and melphalan, and alemtuzumab Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States
Study Start Date : September 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: busulfan, and melphalan, and alemtuzumab
Three drug regimen using busulfan, and melphalan, and alemtuzumab.
Drug: 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:
  • Busulfan (Busulfex®),
  • Melphalan (Alkeran®)
  • Alemtuzumab (Campath®)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997386


Locations
Layout table for location information
United States, Arizona
University Medical Center and UMC-North Clinic
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
University of Arizona
Investigators
Layout table for investigator information
Principal Investigator: Andrew M Yeager, MD University of Arizona
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00997386    
Other Study ID Numbers: 09-0679-04
First Posted: October 19, 2009    Key Record Dates
Results First Posted: December 24, 2018
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by University of Arizona:
Hematologic malignancies
lymphoma, leukemia, MDS (myelodysplastic syndrome)
reduced-intensity preparative regimen
allogeneic peripheral blood stem cell transplant
myelofibrosis or other myeloproliferative syndromes
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms
Hematologic Neoplasms
Hemoglobinuria
Primary Myelofibrosis
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Neoplasms by Site
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Anemia
Anemia, Hemolytic
Myelodysplastic Syndromes
Melphalan