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

NCT01139164 | Terminated Phase 2 Results DMC

• 2 other identifiers: 101370HR#19490
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

high-risk hematological malignancies

Outcome Measures

Primary Outcomes (1)

• To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.

  Number of subject deaths prior to day 100.

  8 years

Secondary Outcomes (2)

• To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants

  Day +100

• Morbidity of Allogeneic Stem Cell Transplants

  100 days

Study Arms (1)

Single Arm, non-randomized study

EXPERIMENTAL

Drug: Regimen A; Drug: Regimen B; Drug: Regimen C

Interventions

Regimen A DRUG

Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.

Single Arm, non-randomized study

Regimen B DRUG

Other malignancies not addressed in A or C

Single Arm, non-randomized study

Regimen C DRUG

B-Cell Lymphomas

Single Arm, non-randomized study

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• Positive anti-donor HLA antibody.
• Identical twin.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

OOS-A regimen; Regimen B

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Robert K Stuart
• Organization: Medical University of South Carolina

stuartrk@musc.edu

843-792-4271

Study Officials

• Robert Stuart, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2015
• Last Updated: July 11, 2018
• Results First Posted: March 10, 2016

Record last verified: 2016-02

Locations

US (1)