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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00714259
Other study ID # F080429003
Secondary ID UAB-0775
Status Terminated
Phase Phase 2/Phase 3
First received July 10, 2008
Last updated June 18, 2013
Start date July 2008
Est. completion date February 2013

Study information

Verified date June 2013
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 70 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United States University of Alabama in Birmingham BMT/CT Program Outpatient Clinic Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progressive Free Survival Post Transplant 100, 180, 365 days post transplant; then yearly until 3 years post transplant No
Secondary Non-relapse treatment related mortality Within 100 days post transplant Yes
Secondary Efficacy of donor lymphocyte infusions required in the treatment of persistent disease and/or early rejection based on chimerism studies. Post transplant as clinically indicated No
Secondary Incidence of acute and chronic graft versus host disease Post transplant No
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