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Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma. (MOD-DHAP)

2026年8月6日 更新者：Abbas Khokhar、King Edward Medical University

Comparison of Effectiveness and Toxicities of Modified DHAP Protocol With Standard DHAP Protocol in Patients With Relapsed/Refractory Diffused Large B-cell Lymphoma.

This Phase III randomized controlled trial evaluates the effectiveness and toxicity profile of a modified DHAP regimen compared to the standard DHAP regimen in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The DHAP regimen (cisplatin, cytarabine, dexamethasone) is widely used as salvage therapy but is associated with significant toxicities, including renal dysfunction and severe myelosuppression. The modified DHAP protocol fractionates cisplatin and cytarabine administration to reduce nephrotoxicity, improve tolerability, and potentially allow outpatient treatment.

A total of 74 patients will be randomized (37 per arm) to receive either the modified or standard DHAP regimen. The primary endpoint is overall response rate (ORR) assessed by RECIL 2017 criteria. Secondary endpoints include progression-free survival (PFS), toxicity incidence and severity graded by CTCAE, and quality of life measured by EORTC QLQ-C30.

The study anticipates that the modified DHAP regimen will demonstrate comparable or superior efficacy with reduced severe toxicities, shorter hospital stays, and improved patient satisfaction. Findings may support transitioning DHAP into outpatient administration, optimizing healthcare resource utilization in Pakistan.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This study is a randomized controlled trial designed to compare the effectiveness and toxicity profile of a modified DHAP regimen versus the standard DHAP regimen in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

DLBCL is the most common subtype of non-Hodgkin lymphoma, with a significant proportion of patients experiencing relapse or refractory disease after initial therapy. The standard DHAP regimen (cisplatin, cytarabine, dexamethasone) has been widely used as salvage therapy, achieving response rates of up to 70%. However, its use is limited by severe toxicities, including renal dysfunction, infections, and profound myelosuppression.

The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cisplatin is fractionated into smaller doses over multiple days rather than a single 24-hour continuous infusion, and cytarabine is administered over two consecutive days. This modification is hypothesized to reduce nephrotoxicity, improve tolerability, and allow outpatient administration, while maintaining or enhancing cytotoxic synergy between cisplatin and cytarabine.

A total of 74 patients will be enrolled and randomized into two arms (37 per arm):

  • Arm A (Modified DHAP): Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 50 mg/m² over 6 hours days 1-2; Cytarabine 2 g/m² IV over 3 hours days 1-2.
  • Arm B (Standard DHAP): Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 100 mg/m² continuous infusion over 24 hours day 1; Cytarabine 2×2 g/m² IV over 3 hours day 2.

Primary endpoint: Overall response rate (ORR), defined as complete or partial response per RECIL 2017 criteria.

Secondary endpoints: Progression-free survival (PFS), toxicity incidence and severity graded by CTCAE, and quality of life (QoL) assessed using the EORTC QLQ-C30 questionnaire.

Patients will be followed for treatment response, adverse events, and QoL changes. Toxicities will be documented using CTCAE forms, with particular attention to hematological toxicities (anemia, neutropenia, thrombocytopenia) and non-hematological toxicities (renal dysfunction, hepatotoxicity, mucositis, neuropathy).

The study anticipates that the modified DHAP regimen will demonstrate comparable or superior efficacy with a reduced incidence of severe toxicities, shorter hospital stays, and improved patient satisfaction. If successful, this regimen could support the transition of DHAP into outpatient administration, optimizing healthcare resource utilization in Pakistan and improving access to therapy for patients with poor prognoses.

研究の種類

介入

入学 (推定)

74

段階

  • フェーズ 3

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。

研究連絡先

研究連絡先のバックアップ

研究場所

  • パキスタン
    • Punjab Province
      • Lahore、Punjab Province、パキスタン、54000
        • 募集
        • Mayo Hospital
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Inbsaat Iqbal, MBBS, MD
        • 副調査官：
          • Hafiz Muhammad Ehsan Arshad, MBBS

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory DLBCL
  • Adults ≥ 18 years
  • At least one prior line of therapy for lymphoma
  • ECOG performance status 0-2
  • Ability to provide informed consent and comply with study requirements
  • Adequate organ function:
  • Hematologic: ANC ≥ 1,000 cells/mm³, Platelets ≥ 75,000 cells/mm³
  • Renal: Serum creatinine ≤ 1.5 × ULN
  • Hepatic: Total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (if no liver metastases)

Exclusion Criteria:

  • History of other malignancies within last 5 years (except non-melanoma skin cancer or localized prostate cancer)
  • Pregnant or breastfeeding women
  • Significant uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes)
  • Receipt of investigational agents within 30 days prior to enrollment
  • Known severe allergic reactions to DHAP components (dexamethasone, cytarabine, cisplatin)
  • Concurrent anti-cancer treatments (chemotherapy, radiotherapy) during study 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：ランダム化
  • 介入モデル：並列代入
  • 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：Modified DHAP
Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 50 mg/m² over 6 hours days 1-2; Cytarabine 2 g/m² IV over 3 hours days 1-2.
薬：Cisplatin (modified schedule)
The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cisplatin is fractionated into smaller doses over multiple days rather than a single 24-hour continuous infusion.
薬：Dexametasone
The standard dexamethasone dosing regimen per RECIL 2017 criteria
他の名前：
  • デクサ
薬：Cytarabine (Ara-C) (Modified schedule)
The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.
アクティブコンパレータ：standard DHAP
Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 100 mg/m² continuous infusion over 24 hours day 1; Cytarabine 2×2 g/m² IV over 3 hours day 2.
薬：Cisplatin

The standard DHAP regimen defined as follows:

  • Dexamethasone: 40 mg orally or intravenously, given daily on days 1-4
  • Cisplatin: 100 mg/m² administered intravenously as a continuous infusion over 24 hours on day 1
  • Cytarabine: 2 × 2 g/m² intravenously over 3 hours, given on day 2 (two doses, 12 hours apart) This cycle is repeated every 21 days for 2-4 cycles, depending on patient tolerance and response.
他の名前：
  • シタラビン
  • デキサメタゾン
薬：Dexametasone
The standard dexamethasone dosing regimen per RECIL 2017 criteria
他の名前：
  • デクサ
薬：Cytarabine (Ara-C)

The standard DHAP regimen defined as follows:

  • Dexamethasone: 40 mg orally or intravenously, given daily on days 1-4
  • Cisplatin: 100 mg/m² administered intravenously as a continuous infusion over 24 hours on day 1
  • Cytarabine: 2 × 2 g/m² intravenously over 3 hours, given on day 2 (two doses, 12 hours apart) This cycle is repeated every 21 days for 2-4 cycles, depending on patient tolerance and response.
他の名前：
  • アラC

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
Overall Response rate (ORR)
時間枠：From enrollment to the end of treatment at 12 weeks

The Overall Response Rate (ORR) is defined as the percentage of patients achieving either a Complete Response (CR) or a Partial Response (PR), assessed according to RECIL 2017 criteria.

  • Complete Response (CR):
  • Disappearance of all target lesions
  • Lymph nodes <10 mm
  • Normalization of FDG-PET (Deauville 1-3)
  • No bone marrow involvement, no new lesions
  • Partial Response (PR):
  • ≥30% decrease in the sum of longest diameters of target lesions
  • FDG-PET positive (Deauville 4-5)
  • May still have bone marrow involvement
  • No new lesions
From enrollment to the end of treatment at 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Complete Response (CR)
時間枠：From enrollment to the end of treatment at 12 weeks
  • Complete Response (CR):
  • Disappearance of all target lesions
  • Lymph nodes <10 mm
  • Normalization of FDG-PET (Deauville 1-3)
  • No bone marrow involvement, no new lesions
From enrollment to the end of treatment at 12 weeks
Partial Response (PR)
時間枠：From enrollment to the end of treatment at 12 weeks
  • Partial Response (PR):
  • ≥30% decrease in the sum of longest diameters of target lesions
  • FDG-PET positive (Deauville 4-5)
  • May still have bone marrow involvement
  • No new lesions
From enrollment to the end of treatment at 12 weeks
Minor Response (MR)
時間枠：From enrollment to the end of treatment at 12 weeks
  • ≥10% decrease in the sum of longest diameters of target lesions, but not enough to qualify as PR (≥30%)
  • FDG-PET may still show uptake (any finding)
  • Bone marrow involvement may persist
  • No new lesions
From enrollment to the end of treatment at 12 weeks
Stable Disease
時間枠：From enrollment to the end of treatment at 12 weeks
  • <10% decrease or ≤20% increase in the sum of longest diameters of target lesions
  • FDG-PET findings may remain positive
  • Bone marrow involvement may persist
  • No new lesions
From enrollment to the end of treatment at 12 weeks
Progressive Disease
時間枠：From enrollment to the end of treatment at 12 weeks
  • >20% increase in the sum of longest diameters of target lesions
  • For small lymph nodes (<15 mm post-therapy), a minimum absolute increase of 5 mm and long diameter >15 mm is required
  • Appearance of new lesions automatically qualifies as PD
  • Any FDG-PET finding consistent with progression
  • Bone marrow involvement may persist or newly appear
From enrollment to the end of treatment at 12 weeks
Quality of Life (QoL)
時間枠：at the end of treatment at 12 weeks
Quality of Life (QoL) defined and measured by EORTC QLQ-C30, a standardized, cancer-specific questionnaire developed by the European Organization for Research and Treatment of Cancer.
at the end of treatment at 12 weeks
Progression free Survival (PFS)
時間枠：From enrollment to up to 2 years post-treatment
the time from randomization (or study entry) until objective disease progression or death from any cause, whichever occurs first as assessed using standardized tumor response criteria (RECIL)
From enrollment to up to 2 years post-treatment
Adverse Events
時間枠：From enrollment to the end of treatment at 12 weeks

Adverse events graded as per CTCAE version 5.0

  • Haematological: anaemia, neutropenia, and thrombocytopenia
  • Non-haematological: renal dysfunction, hepatotoxicity, mucositis, nausea, and neuropathy
From enrollment to the end of treatment at 12 weeks

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

King Edward Medical University

捜査官

  • スタディディレクター：Inbsaat Iqbal, MBBS, MD、King Edward Medical University

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 (実際)

2026年3月18日

一次修了 (推定)

2027年5月20日

研究の完了 (推定)

2027年10月20日

試験登録日

最初に提出

2026年7月28日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年7月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月10日

QC基準を満たした最後の更新が送信されました

2026年8月6日

最終確認日

2026年8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

  • KEMU-IRB-77-RC-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

IPD will not be shared but could be provided by the principal investigator (PI) up on reasonable request

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

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