Clinical trial NCT00714259: Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
Official title: UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
CLL / SLL
Non Hodgkin's Lymphoma
Waldenstroms
Mantle Cell Lymphoma
Keywords: Low Grade B Cell Malignancies
nonmyeloablative transplant
allogeneic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progressive Free Survival Post Transplant
timeFrame: 100 days post transplant
measure: Progressive Free Survival Post Transplant
timeFrame: 180 days post transplant
measure: Progressive Free Survival Post Transplant
timeFrame: 365 days post transplant
measure: Progression Free Survival Post Transplant
timeFrame: 2 years post transplant
Secondary outcomes:
measure: Non-relapse Treatment Related Mortality
timeFrame: Within 100 days post transplant
measure: Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
timeFrame: Post transplant up to 100 days post transplant
measure: Composite Incidence of Acute and Chronic Graft Versus Host Disease
timeFrame: Up to 100 days post transplant.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama in Birmingham BMT/CT Program Outpatient Clinic
state: Alabama
Study officials:
affiliation: University of Alabama in Birmingham
name: William P. Vaughan, MD
role: PRINCIPAL_INVESTIGATOR
References: