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

NCT ID: NCT00714259

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-02-28

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.

Conditions

Multiple Myeloma; CLL / SLL; Non Hodgkin's Lymphoma; Waldenstroms; Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Fludarabine

Intervention Type: DRUG

Fludarabine 30 mg/m2/day x 3 days

Total Body Irradiation

Intervention Type: RADIATION

TBI 200cGy x1 dose on transplant day

Infusion of Stem Cells

Intervention Type: OTHER

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.

Interventions

Fludarabine

Fludarabine 30 mg/m2/day x 3 days

Intervention Type: DRUG

Total Body Irradiation

TBI 200cGy x1 dose on transplant day

Intervention Type: RADIATION

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: OTHER

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Racquel Innis-Shelton, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William P. Vaughan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama in Birmingham

Locations

University of Alabama in Birmingham BMT/CT Program Outpatient Clinic

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-0775

Identifier Type: OTHER

Identifier Source: secondary_id

F080429003

Identifier Type: -

Identifier Source: org_study_id