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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 3; Phase 2

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

Treatments: Other: Infusion of Stem Cells; Drug: Fludarabine; Radiation: Total Body Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00714259

F080429003

UAB-0775 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Non Myeloablative Treatment

Other group

Description:

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.

Treatment:

Drug: Fludarabine

Radiation: Total Body Irradiation

Other: Infusion of Stem Cells