[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649797":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":85,"collaborators":29,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":29,"enrollmentInfo":98,"targetDuration":29,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"King Edward Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Modified DHAP","EXPERIMENTAL","Dexamethasone 40 mg PO\u002FIV days 1-4; Cisplatin 50 mg\u002Fm² over 6 hours days 1-2; Cytarabine 2 g\u002Fm² IV over 3 hours days 1-2.",[13,14,15],"Drug: Cisplatin (modified schedule)","Drug: Dexametasone","Drug: Cytarabine (Ara-C) (Modified schedule)",{"label":17,"type":18,"description":19,"interventionNames":20},"standard DHAP","ACTIVE_COMPARATOR","Dexamethasone 40 mg PO\u002FIV days 1-4; Cisplatin 100 mg\u002Fm² continuous infusion over 24 hours day 1; Cytarabine 2×2 g\u002Fm² IV over 3 hours day 2.",[21,14,22],"Drug: Cisplatin","Drug: Cytarabine (Ara-C)",[24,30,34,40,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","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.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cisplatin","The standard DHAP regimen defined as follows:\n\n* Dexamethasone: 40 mg orally or intravenously, given daily on days 1-4\n* Cisplatin: 100 mg\u002Fm² administered intravenously as a continuous infusion over 24 hours on day 1\n* Cytarabine: 2 × 2 g\u002Fm² 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.",[17],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Dexametasone","The standard dexamethasone dosing regimen per RECIL 2017 criteria",[9,17],[39],"Dexa",{"type":25,"name":41,"description":32,"armGroupLabels":42,"otherNames":43},"Cytarabine (Ara-C)",[17],[44],"Ara-C",{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":29},"Cytarabine (Ara-C) (Modified schedule)","The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.",[9],[50],{"name":51,"affiliation":5,"role":52},"Inbsaat Iqbal, MBBS, MD","STUDY_DIRECTOR",[54,58],{"name":51,"role":55,"phone":56,"phoneExt":29,"email":57},"CONTACT","+923099533745","inbsatiqbal56@gmail.com",{"name":59,"role":55,"phone":60,"phoneExt":29,"email":61},"Hafiz Muhammad Ehsan Arshad, MBBS","+923349830727","ehsanarshadch@gmail.com",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Mayo Hospital","RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":72,"coordinates":73},"Point",[74,75],74.35071,31.558,{"lat":75,"lon":74},[78,80,81,83],{"name":51,"role":55,"phone":79,"phoneExt":29,"email":57},"03099533745",{"name":29,"role":55,"phone":29,"phoneExt":29,"email":57},{"name":51,"role":82,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":84,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"type":82,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Abbas Khokhar","Professor of Medical Oncology and Radiotherapy","100649797","modified-dhap-versus-standard-dhap-in-relapsedrefractory-diffused-large-b-cell-lymphoma-100649797",false,"NCT07739654","Modified DHAP Versus Standard DHAP in Relapsed\u002FRefractory Diffused Large B-cell Lymphoma.","Comparison of Effectiveness and Toxicities of Modified DHAP Protocol With Standard DHAP Protocol in Patients With Relapsed\u002FRefractory Diffused Large B-cell Lymphoma.","MOD-DHAP","Inclusion Criteria:\n\n* Histologically confirmed relapsed or refractory DLBCL\n* Adults ≥ 18 years\n* At least one prior line of therapy for lymphoma\n* ECOG performance status 0-2\n* Ability to provide informed consent and comply with study requirements\n* Adequate organ function:\n* Hematologic: ANC ≥ 1,000 cells\u002Fmm³, Platelets ≥ 75,000 cells\u002Fmm³\n* Renal: Serum creatinine ≤ 1.5 × ULN\n* Hepatic: Total bilirubin ≤ 1.5 × ULN, AST\u002FALT ≤ 2.5 × ULN (if no liver metastases)\n\nExclusion Criteria:\n\n* History of other malignancies within last 5 years (except non-melanoma skin cancer or localized prostate cancer)\n* Pregnant or breastfeeding women\n* Significant uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes)\n* Receipt of investigational agents within 30 days prior to enrollment\n* Known severe allergic reactions to DHAP components (dexamethasone, cytarabine, cisplatin)\n* Concurrent anti-cancer treatments (chemotherapy, radiotherapy) during study period","ALL","18 Years",{"count":99,"type":100},74,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","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\u002Frefractory 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.\n\nA 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.\n\nThe 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.",[106],"DLBCL - Diffuse Large B Cell Lymphoma",[108,109,110],"DLBCL","DHAP","B cell Lymphoma","2026-08-06",{"date":113,"type":114},"2026-08-10","ACTUAL",{"date":116,"type":114},"2026-03-18",{"date":118,"type":100},"2027-10-20",{"name":5,"class":6},1]