Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
- Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.
PROJECTED ACCRUAL: Not specified
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Cancer Center
-
-
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:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Philadelphia chromosome positive OR
- BCR/ABL rearrangement
- Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
- 70 and under
Performance status:
- Age 65-70 years:
- Karnofsky 80-100%
- Under 65 years:
- Karnofsky 90-100%
Renal:
- Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
- Under 65 years:
- Not specified
Cardiovascular:
- Age 65-70 years:
- LVEF at least 45%
Pulmonary:
- Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted
- Normal organ function (excluding bone marrow)
Exclusion Criteria:
- Blast crisis or post blast crisis
- Severe fibrosis defined by bilateral trephine biopsies
- Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
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 |
|---|---|
|
実験的：Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
|
intravenously over 2 hours on day 1 and on days -7 and -6
他の名前：
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis.
Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
他の名前：
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
他の名前：
Patients receive the PBSC transplantation on day 0.
他の名前：
total body irradiation twice a day on days -4 through -1
他の名前：
|
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 |
|---|
|
Time to hemopoietic recovery after transplantation
|
|
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
|
二次結果の測定
結果測定 |
|---|
|
死因
|
|
Time to initial hospital discharge
|
|
Peritransplantation toxicity
|
|
Quality of life at various time points
|
協力者と研究者
捜査官
- スタディチェア：Catherine M. Verfaillie, MD、Masonic Cancer Center, University of Minnesota
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 (実際)
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
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
- 1996LS183
- UMN-MT-1996-11 (その他の識別子：Blood and Marrow Transplantation Program)
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