Study of Reduced Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) to Treat Hematologic Malignancies and Hematopoietic Failure States (ALBUM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Andrew Yeager, University of Arizona
ClinicalTrials.gov Identifier:
NCT00997386
First received: October 15, 2009
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Hematologic Neoplasms
Multiple Myeloma
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Myelofibrosis
Drug: busulfan, and melphalan, and alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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). [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analyses of relapse-free survival, event-free survival and overall survival will be performed [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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®)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997386

Contacts
Contact: Phyllis Schneider, RN 520-694-9070 pschneider@azcc.arizona.edu
Contact: Andrew M Yeager, MD 520-626-0662 ayeager@azcc.arizona.edu

Locations
United States, Arizona
University Medical Center and UMC-North Clinic Recruiting
Tucson, Arizona, United States, 85719
Contact: Schneider       pschneider@azcc.arizona.edu   
Contact: Yeager       ayeager@azcc.arizona.edu   
Principal Investigator: Andrew M Yeager, MD         
Sponsors and Collaborators
Andrew Yeager
  More Information

No publications provided

Responsible Party: Andrew Yeager, Professor of Medicine and Pediatrics, University of Arizona
ClinicalTrials.gov Identifier: NCT00997386     History of Changes
Other Study ID Numbers: 09-0679-04
Study First Received: October 15, 2009
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

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:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Primary Myelofibrosis
Hemoglobinuria
Hematologic Neoplasms
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
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
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Neoplasms by Site
Anemia
Anemia, Hemolytic
Myelodysplastic Syndromes

ClinicalTrials.gov processed this record on September 18, 2014