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

Primary Purpose

Hematological Malignancies

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Regimen A

Regimen B

Regimen C

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring high-risk hematological malignancies

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm, non-randomized study

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants

To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome

Morbidity of Allogeneic Stem Cell Transplants

To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications.

Full Information

NCT ID

NCT01139164

First Posted

June 4, 2010

Last Updated

June 13, 2018

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01139164

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Study halted prematurely due to low accrual.

Study Start Date

June 2010 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Malignancies

Keywords

high-risk hematological malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm, non-randomized study

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Regimen A

Intervention Description

Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.

Intervention Type

Drug

Intervention Name(s)

Regimen B

Intervention Description

Other malignancies not addressed in A or C

Intervention Type

Drug

Intervention Name(s)

Regimen C

Intervention Description

B-Cell Lymphomas

Primary Outcome Measure Information:

Title

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

Description

Number of subject deaths prior to day 100.

Time Frame

8 years

Secondary Outcome Measure Information:

Title

To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants

Description

Time Frame

Day +100

Title

Morbidity of Allogeneic Stem Cell Transplants

Description

Time Frame

100 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Stuart, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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