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

October 15, 2009
January 31, 2013
September 2009
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00997386 on ClinicalTrials.gov Archive Site
Analyses of relapse-free survival, event-free survival and overall survival will be performed [ Time Frame: Day +100 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Reduced Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematologic Neoplasms
  • Multiple Myeloma
  • Anemia, Aplastic
  • Hemoglobinuria, Paroxysmal
  • Myelofibrosis
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®)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Phyllis Schneider, RN 520-694-9070 pschneider@azcc.arizona.edu
Contact: Andrew M Yeager, MD 520-626-0662 ayeager@azcc.arizona.edu
United States
 
NCT00997386
09-0679-04
Yes
Andrew Yeager, University of Arizona
Andrew Yeager
Not Provided
Not Provided
University of Arizona
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP