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

June 22, 2017 updated by: Racquel Innis-Shelton, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-6979
        • University of Alabama in Birmingham BMT/CT Program Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non Myeloablative Treatment

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.
Drug: Fludarabine
Fludarabine 30 mg/m2/day x 3 days
Radiation: Total Body Irradiation
TBI 200cGy x1 dose on transplant day
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive Free Survival Post Transplant
Time Frame: 100 days 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.
100 days post transplant
Progressive Free Survival Post Transplant
Time Frame: 180 days 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.
180 days post transplant
Progressive Free Survival Post Transplant
Time Frame: 365 days 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.
365 days post transplant
Progression Free Survival Post Transplant
Time Frame: 2 years 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.
2 years post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-relapse Treatment Related Mortality
Time Frame: Within 100 days post transplant
Death related to treatment without relapse within 100 days after transplant
Within 100 days post transplant
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Time Frame: Post transplant 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.
Post transplant up to 100 days post transplant
Composite Incidence of Acute and Chronic Graft Versus Host Disease
Time Frame: Up to 100 days post transplant.
Up to 100 days post transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: William P. Vaughan, MD, University of Alabama in Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F080429003
  • UAB-0775 (Other Identifier: UAB Cancer Center study number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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