NCT00714259 · REGISTRY CONDITION SEARCH

Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2, PHASE3
Status at capture: TERMINATED
Registry last update: 2017-07-24

A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progressive Free Survival Post Transplant

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outcome · POSTED

Non-relapse Treatment Related Mortality

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outcome · POSTED

Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant

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outcome · POSTED

Composite Incidence of Acute and Chronic Graft Versus Host Disease

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outcome · POSTED

Progressive Free Survival Post Transplant

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outcome · POSTED

Progressive Free Survival Post Transplant

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outcome · POSTED

Progression Free Survival Post Transplant

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Stage II or III non-progressive disease Multiple Myeloma. * CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease. * ≤ 70 years old. * Eligible and willing HLA matched related donor. * Bilirubin \<2xULN. * ALT and AST \<3xULN. * LVEF \> 40%. * Creatinine Clearance \>40mL/min. * Pulmonary function DLCO corrected to ≥ 70%. * Minimum performance score of 70%. * Platelet count \>130 x103 micro L. * LDH ≤1.5xULN. * No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity. * No uncontrolled infections. Exclusion Criteria: * Age \>70 years old. * Performance status \<70%. * Uncontrolled infections or is HIV positive * Prior malignancies that are felt to have a \<80% probability of being cured. * Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant. * Prior Allograft * History of rapidly growing disease at diagnosis or at any progression or have MDS. * No eligible and willing HLA matched donor.
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 19 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.
intervention Names
Drug: Fludarabine
Radiation: Total Body Irradiation
Other: Infusion of Stem Cells
label
Non Myeloablative Treatment
type
OTHER

interventions

arm Group Labels
Non Myeloablative Treatment
description
Fludarabine 30 mg/m2/day x 3 days
name
Fludarabine
type
DRUG
arm Group Labels
Non Myeloablative Treatment
description
TBI 200cGy x1 dose on transplant day
name
Total Body Irradiation
type
RADIATION
arm Group Labels
Non Myeloablative Treatment
description
On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.
name
Infusion of Stem Cells
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
measure
Progressive Free Survival Post Transplant
time Frame
100 days post transplant
description
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
measure
Progressive Free Survival Post Transplant
time Frame
180 days post transplant
description
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
measure
Progressive Free Survival Post Transplant
time Frame
365 days post transplant
description
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
measure
Progression Free Survival Post Transplant
time Frame
2 years post transplant

secondary Outcomes

description
Death related to treatment without relapse within 100 days after transplant
measure
Non-relapse Treatment Related Mortality
time Frame
Within 100 days post transplant
description
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
measure
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
time Frame
Post transplant up to 100 days post transplant
measure
Composite Incidence of Acute and Chronic Graft Versus Host Disease
time Frame
Up to 100 days post transplant.

Full study description

brief Summary: A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
detailed Description: Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
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primary nct id
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payload
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exact text
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query cond
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query disease state id
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source file
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source kind
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source string sha256
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source url
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Preserved source evidence · Not medical advice