Reduced Intensity Double Umbilical Cord Blood Transplantation
2018年12月29日 更新者：Zachariah Michael DeFilipp、Massachusetts General Hospital
A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.
Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
調査の概要
状態
完了
詳細な説明
Subjects will receive their transplants as in-patients.
IV-Catheter
- one or two IV catheters will be placed on the day of hospital admission
Conditioning
- Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
- Melphalan IV (day -1)
- Total body radiation on day 0 (same day as transplant)
Immunosuppressive Therapy
- Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient
Infusion of Cord Blood units
- 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided
研究の種類
介入
入学 (実際)
33
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
-
Boston、Massachusetts、アメリカ、02215
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
- Appropriate candidate for reduced intensity regimen, according to the treating physician
- Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
- Able to comply with the requirements for care after allogeneic stem cell transplantation
Exclusion Criteria:
- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
- Renal disease
- Hepatic disease
- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV-positive
- Uncontrolled infection
- Pregnant or breast-feeding
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Fludarabine/Melphalan/TBI
All patients receive same therapy
|
30 mg/m2/day IV x 6 days
他の名前：
100mg/m2/日 IV×1日
200 cGy on Day 0
2 cord blood units IV
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With a Clinically Significant Infection
時間枠：1 Year
|
The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation.
The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
|
1 Year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Median Time to Neutrophil Engraftment
時間枠：From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
|
The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment.
neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count > 500 neutrophils per microliter of blood.
|
From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
|
|
Median Time to Platelet Engraftment
時間枠：From the time of transplantation, until the time of platelet engraftment, median duration of 52 days
|
The time to platelet engraftment is measured from the time of transplantation until the time of first documented platelet engraftment.
Platelet engraftment is defined as a platelet count ≥ 20,000/µL for three consecutive measurements over three or more days.
The first of the three days will be designated the day of platelet engraftment.
Subjects must not have had platelet transfusions during the preceding 3 days or in the following 7 days after the day of engraftment, unless the platelet transfusion is being given specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal.
|
From the time of transplantation, until the time of platelet engraftment, median duration of 52 days
|
|
Number of Participants With Primary Graft Failure
時間枠：From the time of transplantation until 42 days post transplantation
|
Primary graft failure is defined as the failure to achieve an absolute neutrophil count (ANC) >500/ µL by day 42, in the absence of relapse.
|
From the time of transplantation until 42 days post transplantation
|
|
Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
時間枠：100 Days
|
Acute GVHD is assessed using Consensus Criteria: Organ Classifications:
Overall Clinical Grade:
|
100 Days
|
|
The Rate of Chronic GVHD
時間枠：From the time of transplantation until the time of chronic GVHD onset, up to 1 year
|
Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.
|
From the time of transplantation until the time of chronic GVHD onset, up to 1 year
|
|
100-day Treatment Related Mortality
時間枠：100 Days
|
The percentage of treatment related participant deaths within 100 days of receiving umbilical cord blood transplantation.
All deaths in the absence of relapse of the primary malignancy will be considered treatment related mortality.
|
100 Days
|
|
Immune Reconstitution - Median CD4 Count at 12 Months
時間枠：1 Year
|
1 Year
|
|
|
Relapse-free Survival
時間枠：2 years
|
The percentage of participants that have not died or had disease progression by two years.
Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
|
2 years
|
|
Overall Survival
時間枠：2 years
|
The percentage of participants alive at two years
|
2 years
|
|
1 Year Relapse Rate
時間枠：1 year
|
The percentage of participants that relapsed within 12 months.
Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
|
1 year
|
|
Rate of Post-transplant Lymphoma
時間枠：2.5 years
|
The number of participants that were found to have lymphoma post-transplant.
|
2.5 years
|
|
Median Thrombopoietin Levels After Transplant
時間枠：30 Days
|
30 Days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Zachariah DeFilipp, MD、Massachusetts General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年12月1日
一次修了 (実際)
2017年6月1日
研究の完了 (実際)
2017年6月1日
試験登録日
最初に提出
2011年8月2日
QC基準を満たした最初の提出物
2011年8月2日
最初の投稿 (見積もり)
2011年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月23日
QC基準を満たした最後の更新が送信されました
2018年12月29日
最終確認日
2018年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 11-085
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