Umbilical Cord Blood Transplant for Hematological Malignancies (UCB)
A Phase 1 Dose Escalation Study of Infusion of ex Vivo cd3/cd28 Costimulated Umbilical Cord Blood-derived t Cells in Adults Undergoing Transplantation for Advanced Hematologic Malignancies
This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant.
In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent to a laboratory in order to grow the T cells (from the cord blood) and increase the activity of the cord blood T cells.
The purpose of this part of the study is to see if it is safe to give study subjects activated T cells made from a small portion of their donor UCB unit immediately after the UCB transplant. Activated T cells have been used safely in stem cell transplantation studies in the past, but they have never been studied UCB transplantation.
調査の概要
状態
詳細な説明
The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen.
Activated T cells are T cells that have been activated in the laboratory by exposure to 2 compounds or molecules called CD3 and CD28; when T cells are exposed to both of these compounds at the same time, they become activated or "stimulated" and may be more effective in fighting infections, cancer cells, and promoting the recovery of red cells, white cells, and platelets after transplantation. At the Hospital of the University of Pennsylvania, activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also known as the CVPF.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria.
- Relapsed or persistent advanced hematologic malignancy; incurable with standard chemotherapy and eligible for allogeneic HSCT, including:
- CHRONIC MYELOGENOUS LEUKEMIA (CML). Subjects in accelerated or blast phase or subjects in chronic phase with inadequate response to Imatinib or intolerant to Imatinib.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subject with high risk disease in first complete remission (CR). High risk disease includes the following cytogenetic abnormalities: monosomy 7, deletion 5, trisomy 8, inversion 3, t(3;3), t(6;9), or t(6;11). Subjects with complex cytogenetic abnormalities (more than 3 chromosomal abnormalities).
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with diagnosis of AML after receiving chemotherapy, radiation therapy or biopsy showing myelodysplastic syndrome.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with persistent AML after 2 cycles of standard induction chemotherapy.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects in first complete remission.
- MYELODYSPLASTIC SYNDROME (MDS). Subjects with intermediate or high risk disease based upon International Prognostic Scoring System.
- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with Philadelphia Chromosome (have t(9;22) cytogenetic abnormality) or molecular documentation for BCR-ABL translocation.
- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with primary refractory disease or subjects in 1st complete remission.
- NHL or HODKIN'S DISEASE. Subjects who relapse following autologous Stem Cell Transplant.
- INDOLENT NHL. Subjects with progressive disease following > 2 regimens.
- MULTIPLE MYELOMA. Subjects who relapse following following autologous Stem Cell Transplant.
- Adults age 21-50.
- Expected survival 4 weeks.
- Subjects with no suitable related or unrelated donor for Stem Cell Transplant.
- Subject has suitable Umbilical Cord Blood (UCB) unit available.
- Subject has: Ejection fraction > 45%; DLCO.45% predicted; Creatinine < 2; Total bilirubin < 2X normal; Transaminases < 2X normal.
- Subject is capable of giving informed consent.
Exclusion Criteria:
- Subject is pregnant or lactating.
- Subject has an uncontrolled infection.
- Subject has an active or untreated disease involving the central nervous system.
- Subject has an active or uncontrolled medical condition that would preclude participation in the protocol.
研究計画
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：非ランダム化
- 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 |
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実験的：Dose Escalation Arm
Subjects with cord blood stored in more than one fraction will be enrolled into Dose Escalation Arm.
Subjects will receive Cord Blood Stem Cell Transplant followed by expanded Cord Blood T cells on Day 0.
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Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells. Table 6: Dose escalation (Dose level CD3+ cell dose)
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アクティブコンパレータ：Observation Arm
Subjects with cord blood stored in one fraction will be enrolled into the Observation Arm.
Subjects will receive Cord Blood Stem Cell Transplant on Day 0.
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Single infusion of Cord Blood Cells
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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 |
時間枠 |
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Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion.
時間枠：90 Days post Transplant
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90 Days post Transplant
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協力者と研究者
捜査官
- 主任研究者：David Porter, MD、University of Pennsylvania
- 主任研究者：Elizabeth Hexner, MD、University of Pennsylvania
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cellsの臨床試験
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Abramson Cancer Center of the University of Pennsylvania終了しました