- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01139164
Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)
13. juni 2018 opdateret af: Medical University of South Carolina
Allogeneic Hematopoietic Stem Cell Transplantation With Reduced-Intensity Pre-Transplant Conditioning for the Treatment of High-Risk Hematological Malignancies
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
78
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 75 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Single Arm, non-randomized study
|
Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.
Other malignancies not addressed in A or C
B-Cell Lymphomas
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.
Tidsramme: 8 years
|
Number of subject deaths prior to day 100.
|
8 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants
Tidsramme: Day +100
|
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
|
Day +100
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Morbidity of Allogeneic Stem Cell Transplants
Tidsramme: 100 days
|
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.
|
100 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Robert Stuart, MD, Medical University of South Carolina
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
4. juni 2010
Først indsendt, der opfyldte QC-kriterier
7. juni 2010
Først opslået (Skøn)
8. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juni 2018
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 101370
- HR#19490 (Anden identifikator: MUSC IRB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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