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

NCT00714259 | Terminated Phase 2 Results DMC

• 2 other identifiers: F080429003UAB-0775
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Low Grade B Cell Malignancies; nonmyeloablative transplant; allogeneic

Outcome Measures

Primary Outcomes (4)

• Progressive Free Survival Post Transplant

  subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.

  100 days post transplant

• Progressive Free Survival Post Transplant

  Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.

  180 days post transplant

• Progressive Free Survival Post Transplant

  Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.

  365 days post transplant

• Progression Free Survival Post Transplant

  Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.

  2 years post transplant

Secondary Outcomes (3)

• Non-relapse Treatment Related Mortality

  Within 100 days post transplant

• Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant

  Post transplant up to 100 days post transplant

• Composite Incidence of Acute and Chronic Graft Versus Host Disease

  Up to 100 days post transplant.

Study Arms (1)

Non Myeloablative Treatment

OTHER

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.

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

Interventions

Fludarabine DRUG

Fludarabine 30 mg/m2/day x 3 days

Non Myeloablative Treatment

Total Body Irradiation RADIATION

TBI 200cGy x1 dose on transplant day

Non Myeloablative Treatment

Infusion of Stem Cells 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.

Non Myeloablative Treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama in Birmingham BMT/CT Program Outpatient Clinic

Birmingham, Alabama, 35249-6979, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Leukemia, B-Cell

Interventions

fludarabine; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, Lymphoid; Leukemia

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: William Vaughan, MD
• Organization: UAB

liwilliams@uabmc.edu

20-934-0066

Study Officials

• William P. Vaughan, MD

  University of Alabama in Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 24, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)