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

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.

Eligibility

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

Conditions2

Interventions1

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