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AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

2014年2月10日 更新者：Genzyme, a Sanofi Company

Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease

Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5*10^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Participants with HD who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this study. The only changes to the standard of care is the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis and the collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD) analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor. Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the investigator's discretion.

The primary endpoint is the proportion of HD participants who collect ≥5*10^6 CD34+ cells/kg with this mobilization regimen. The secondary endpoints include the safety of this mobilization regimen, the proportion of participants who collect ≥2*10^6 CD34+ cells/kg, the change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and the number of days of apheresis required to obtain ≥5*10^6 CD34+ cells/kg. In addition, success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

研究の種類

介入

入学 (実際)

22

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

  • アメリカ
    • Missouri
      • St Louis、Missouri、アメリカ、63110-1093
        • Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia

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:

  • Diagnosis of HD eligible for autologous transplantation
  • No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy for the purpose of this study.)
  • 4 weeks since last cycle of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • White blood cell count (WBC) >3.0*10^9/L
  • Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L
  • Platelet (PLT) count >100*10^9/L
  • Serum creatinine ≤2.2 mg/DL
  • Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
  • Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
  • Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
  • Negative for human immunodeficiency virus (HIV)

Exclusion Criteria:

  • A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
  • Patients who have failed previous collections
  • A residual acute medical condition resulting from prior chemotherapy
  • Hodgkin's disease involving the central nervous system
  • Acute infection
  • Fever (temp >38°C/100.4°F)
  • Patients whose actual body weight exceeds 150% of their ideal body weight
  • History of ventricular arrhythmias
  • History of paresthesias
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period

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：Participants with Hodgkin's Disease (HD)
Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation.
薬：G-CSF Plus Plerixafor
Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
他の名前：
  • AMD3100
  • モゾビル

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
Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
時間枠：Day 5 up to Day 9
The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.
Day 5 up to Day 9

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Participant Counts of Adverse Events During the Treatment Period
時間枠：Day 0 - approximately day 38

Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.

See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious.
Day 0 - approximately day 38
Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
時間枠：Day 5 up to day 9
The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.
Day 5 up to day 9
Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
時間枠：Days 4-5 (first dose of plerixafor to apheresis)
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Days 4-5 (first dose of plerixafor to apheresis)
Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg
時間枠：Day 5 up to day 9
Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.
Day 5 up to day 9
Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment
時間枠：Up to Month 13 (up to 12 months post transplant)
Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Up to Month 13 (up to 12 months post transplant)
Number of Days Post Transplantation to Platelet (PLT) Engraftment
時間枠：Up to Month 13 (up to 12 months post transplant)
Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.
Up to Month 13 (up to 12 months post transplant)
Number of Participants With a Durable Graft at 12 Months
時間枠：13 months
Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.
13 months
Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor
時間枠：Day 4
Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.
Day 4
Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor
時間枠：Day 4
Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.
Day 4
Half-life (T1/2) Following a Single Dose of Plerixafor
時間枠：Day 4
Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.
Day 4
Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor
時間枠：Days 4-5
Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.
Days 4-5
Apparent Clearance (CL/F) of Single-dose Plerixafor
時間枠：Day 4-5
Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).
Day 4-5
Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor
時間枠：Day 4
The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.
Day 4

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。

スポンサー

Genzyme, a Sanofi Company

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2004年11月1日

一次修了 (実際)

2006年10月1日

研究の完了 (実際)

2008年1月1日

試験登録日

最初に提出

2006年11月2日

QC基準を満たした最初の提出物

2006年11月2日

最初の投稿 (見積もり)

2006年11月6日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年3月13日

QC基準を満たした最後の更新が送信されました

2014年2月10日

最終確認日

2014年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AMD3100-2106

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