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Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

Primary Purpose

Multiple Myeloma, CLL / SLL, Non Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fludarabine
Total Body Irradiation
Infusion of Stem Cells
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Low Grade B Cell Malignancies, nonmyeloablative transplant, allogeneic

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage II or III non-progressive disease Multiple Myeloma.
  • CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
  • ≤ 70 years old.
  • Eligible and willing HLA matched related donor.
  • Bilirubin <2xULN.
  • ALT and AST <3xULN.
  • LVEF > 40%.
  • Creatinine Clearance >40mL/min.
  • Pulmonary function DLCO corrected to ≥ 70%.
  • Minimum performance score of 70%.
  • Platelet count >130 x103 micro L.
  • LDH ≤1.5xULN.
  • No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
  • No uncontrolled infections.

Exclusion Criteria:

  • Age >70 years old.
  • Performance status <70%.
  • Uncontrolled infections or is HIV positive
  • Prior malignancies that are felt to have a <80% probability of being cured.
  • Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
  • Prior Allograft
  • History of rapidly growing disease at diagnosis or at any progression or have MDS.
  • No eligible and willing HLA matched donor.

Sites / Locations

  • University of Alabama in Birmingham BMT/CT Program Outpatient Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Non Myeloablative Treatment

Arm Description

Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.

Outcomes

Primary Outcome Measures

Progressive Free Survival Post Transplant
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progressive Free Survival Post Transplant
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progressive Free Survival Post Transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Progression Free Survival Post Transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.

Secondary Outcome Measures

Non-relapse Treatment Related Mortality
Death related to treatment without relapse within 100 days after transplant
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
Composite Incidence of Acute and Chronic Graft Versus Host Disease

Full Information

First Posted
July 10, 2008
Last Updated
June 22, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00714259
Brief Title
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
Official Title
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Accrual goals could not be met within a timely manner
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Detailed Description
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, CLL / SLL, Non Hodgkin's Lymphoma, Waldenstroms, Mantle Cell Lymphoma
Keywords
Low Grade B Cell Malignancies, nonmyeloablative transplant, allogeneic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Myeloablative Treatment
Arm Type
Other
Arm Description
Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine 30 mg/m2/day x 3 days
Intervention Type
Radiation
Intervention Name(s)
Total Body Irradiation
Intervention Description
TBI 200cGy x1 dose on transplant day
Intervention Type
Other
Intervention Name(s)
Infusion of Stem Cells
Intervention Description
On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
Primary Outcome Measure Information:
Title
Progressive Free Survival Post Transplant
Description
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Time Frame
100 days post transplant
Title
Progressive Free Survival Post Transplant
Description
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Time Frame
180 days post transplant
Title
Progressive Free Survival Post Transplant
Description
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
Time Frame
365 days post transplant
Title
Progression Free Survival Post Transplant
Description
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
Time Frame
2 years post transplant
Secondary Outcome Measure Information:
Title
Non-relapse Treatment Related Mortality
Description
Death related to treatment without relapse within 100 days after transplant
Time Frame
Within 100 days post transplant
Title
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Description
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
Time Frame
Post transplant up to 100 days post transplant
Title
Composite Incidence of Acute and Chronic Graft Versus Host Disease
Time Frame
Up to 100 days post transplant.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage II or III non-progressive disease Multiple Myeloma. CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease. ≤ 70 years old. Eligible and willing HLA matched related donor. Bilirubin <2xULN. ALT and AST <3xULN. LVEF > 40%. Creatinine Clearance >40mL/min. Pulmonary function DLCO corrected to ≥ 70%. Minimum performance score of 70%. Platelet count >130 x103 micro L. LDH ≤1.5xULN. No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity. No uncontrolled infections. Exclusion Criteria: Age >70 years old. Performance status <70%. Uncontrolled infections or is HIV positive Prior malignancies that are felt to have a <80% probability of being cured. Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant. Prior Allograft History of rapidly growing disease at diagnosis or at any progression or have MDS. No eligible and willing HLA matched donor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William P. Vaughan, MD
Organizational Affiliation
University of Alabama in Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama in Birmingham BMT/CT Program Outpatient Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-6979
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

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