Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01139164
• Date of registration: 04/06/2010
• Primary sponsor: Medical University of South Carolina
• Public title: Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)
• Scientific title: Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)
• Date of first enrolment: June 2010
• Target sample size: 89
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01139164
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Karen Rogers

• Name: Jessica Simons

• Name: Robert Stuart, MD
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

- A proven diagnosis of one of the conditions in Table 1.

- Prior therapy including blood or marrow transplant will not exclude patients for
reduced intensity transplant.

- Age < 75 years. Pediatric patients are eligible from the ages of 1 month to 18 years
if the transplant physician believes that co-morbid conditions significantly increase
the risk for a standard transplant regimen.

- HIV antibody negative.

- ECOG performance status 0-3, (or equivalent Karnofsky and Lansky performance scores
for patients <18yrs, see appendix 2)

- Availability of an HLA-identical related donor or suitable alternative donor, (=7/8
allele match at A, B, C and DRB). Syngeneic transplants will not be allowed in this
protocol.

- Due to the complexity of the study, all patients prior to enrollment will be assessed
by the PI or co-PI.

- Patient with marrow failure states or immune deficiency syndromes undergoing stem
cell transplants must be reviewed by one of the investigators to determine
eligibility for study.

- Adequate insurance coverage (or financial resources) to cover the costs associated
with the patient's transplant and, in the case of patients eligible for cohort C, to
cover the costs associated with I 131 Tositumomab treatment.

Exclusion Criteria:

- Active CNS involvement with malignant disease.

- Pregnancy.

- Fertile men or women unwilling to use contraceptive techniques during the study
period.

- Creatinine clearance < 30 ml/min.

- Left ventricular ejection fraction <30% or clinical cardiac failure uncontrolled by
medical therapy.

- Pulmonary disease requiring supplemental oxygen therapy.

- Patients with estimated life span less than 1 year due to medical illnesses other
than the condition being treated on the study.

Donor Selection:

Inclusion Criteria

- Major HLA identical relative or genotypically matched unrelated donor (7-8/8 alleles)
.

- Donors must meet the selection criteria as defined by the Foundation for the
Accreditation of Cell Therapy (FACT) and will be screened per the American
Association of Blood Banks (AABB) guidelines.

Exclusion Criterion

- Positive anti-donor HLA antibody.

- Identical twin.



Age minimum: 1 Year
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hematological Malignancies

Intervention(s)

Drug: Regimen A

Drug: Regimen B

Drug: Regimen C

Primary Outcome(s)

To determine the treatment-related mortality rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens within 1st 100-days. [Time Frame: 8 years]

Secondary Outcome(s)

To determine the engraftment rate of allogeneic stem cell transplants [Time Frame: 8 years]

Secondary ID(s)

101370

HR#19490

Source(s) of Monetary Support

Please refer to primary and secondary sponsors