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Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
Sponsor: King Edward Medical University
Summary
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.
Official title: Comparison of Effectiveness and Toxicities of Modified DHAP Protocol With Standard DHAP Protocol in Patients With Relapsed/Refractory Diffused Large B-cell Lymphoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2026-03-18
Completion Date
2027-10-20
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Dexametasone
The standard dexamethasone dosing regimen per RECIL 2017 criteria
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.
Cytarabine (Ara-C) (Modified schedule)
The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.
Locations (1)
Mayo Hospital
Lahore, Punjab Province, Pakistan