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

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Fludarabine; Fludarabine phosphate

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.