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

Multiple Myeloma Clinical Trial

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

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

Related Conditions & MeSH terms

• CLL / SLL
• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Multiple Myeloma
• Non Hodgkin's Lymphoma
• Waldenstroms

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