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

Primary Purpose

Hematologic Neoplasms, Multiple Myeloma, Anemia, Aplastic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan, and melphalan, and alemtuzumab
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematologic malignancies, lymphoma, leukemia, MDS (myelodysplastic syndrome), reduced-intensity preparative regimen, allogeneic peripheral blood stem cell transplant, myelofibrosis or other myeloproliferative syndromes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center and UMC-North Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

busulfan, and melphalan, and alemtuzumab

Arm Description

Three drug regimen using busulfan, and melphalan, and alemtuzumab.

Outcomes

Primary Outcome Measures

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).
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

Number of Participants With Relapse-free Survival.
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.
Number of Participants With Event-free Survival.
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.
Number of Participants With Overall Survival.
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.

Full Information

First Posted
October 15, 2009
Last Updated
September 5, 2019
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT00997386
Brief Title
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
Acronym
ALBUM
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 Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms, Multiple Myeloma, Anemia, Aplastic, Hemoglobinuria, Paroxysmal, Myelofibrosis
Keywords
Hematologic malignancies, lymphoma, leukemia, MDS (myelodysplastic syndrome), reduced-intensity preparative regimen, allogeneic peripheral blood stem cell transplant, myelofibrosis or other myeloproliferative syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
busulfan, and melphalan, and alemtuzumab
Arm Type
Experimental
Arm Description
Three drug regimen using busulfan, and melphalan, and alemtuzumab.
Intervention Type
Drug
Intervention Name(s)
busulfan, and melphalan, and alemtuzumab
Other Intervention Name(s)
Busulfan (Busulfex®),, Melphalan (Alkeran®), Alemtuzumab (Campath®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
Day +100
Secondary Outcome Measure Information:
Title
Number of Participants With Relapse-free Survival.
Description
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.
Time Frame
Day +100
Title
Number of Participants With Event-free Survival.
Description
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.
Time Frame
Day +100
Title
Number of Participants With Overall Survival.
Description
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.
Time Frame
Day +100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Yeager, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center and UMC-North Clinic
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States

12. IPD Sharing Statement

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

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