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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	19 to 70	Other	F080429003 UAB-0775, NCT00714259

Trial Description

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.

Further Study Information

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.

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

William P. Vaughan

Principal Investigator

William P. Vaughan, MD		Ph: 205-934-9695
		Email: Wvaughan@uabmc.edu

Lisa D. Williams, RN		Ph: 205-934-0066
		Email: LiWilliams@uabmc.edu

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		William P. Vaughan, MD	Ph: 205-934-9695
			Email: Wvaughan@uabmc.edu
		Lisa D. Williams, RN	Ph: 205-934-0066
			Email: LiWilliams@uabmc.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00714259
Information obtained from ClinicalTrials.gov on March 18, 2009