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

NCT ID: NCT01139164

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Hematological Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm, non-randomized study

Group Type: EXPERIMENTAL

Regimen A

Intervention Type: DRUG

Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.

Regimen B

Intervention Type: DRUG

Other malignancies not addressed in A or C

Regimen C

Intervention Type: DRUG

B-Cell Lymphomas

Interventions

Regimen A

Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.

Intervention Type: DRUG

Regimen B

Other malignancies not addressed in A or C

Intervention Type: DRUG

Regimen C

B-Cell Lymphomas

Intervention Type: DRUG

Eligibility 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.

• 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.

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:

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

HR#19490

Identifier Type: OTHER

Identifier Source: secondary_id

101370

Identifier Type: -

Identifier Source: org_study_id