Allogeneic Hematopoietic Stem Cell Transplantation With Reduced-Intensity Pre-Transplant Conditioning for the Treatment of High-Risk Hematological Malignancies

Medical University of South Carolina1 site in 1 country78 target enrollmentJune 2010

ConditionsHematological Malignancies

InterventionsRegimen A Regimen B Regimen C

DrugsRegimen B Regimen A Regimen C

Overview

Phase: Phase 2
Intervention: Regimen A
Conditions: Hematological Malignancies
Sponsor: Medical University of South Carolina
Enrollment: 78
Locations: 1
Primary Endpoint: To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

December 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A proven diagnosis of one of the conditions in Table
•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) .

Arms & Interventions

Single Arm, non-randomized study

Intervention: Regimen A

Single Arm, non-randomized study

Intervention: Regimen B

Single Arm, non-randomized study

Intervention: Regimen C

Outcomes

Primary Outcomes

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

Number of subject deaths prior to day 100.