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.
Verified January 2013 by University of Arizona
Sponsor:
Andrew Yeager
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
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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:
Detailed Description:
-
Drug: busulfan, and melphalan, and alemtuzumab
- Busulfan (Busulfex®),
- Melphalan (Alkeran®)
- Alemtuzumab (Campath®)
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:
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
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:
|
Primary Myelofibrosis Anemia Anemia, Aplastic Neoplasms Hemoglobinuria Hemoglobinuria, Paroxysmal Multiple Myeloma Neoplasms, Plasma Cell Hematologic Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Proteinuria Urination Disorders Urologic Diseases |
Urological Manifestations Signs and Symptoms Anemia, Hemolytic Myelodysplastic Syndromes Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplasms by Site |
ClinicalTrials.gov processed this record on June 18, 2013