NCT07739654RecruitingPhase 3
Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
Comparison of Effectiveness and Toxicities of Modified DHAP Protocol With Standard DHAP Protocol in Patients With Relapsed/Refractory Diffused Large B-cell Lymphoma.
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 18 Mar 2026
- Primary completion date
- 20 May 2027
- Lead sponsor
- King Edward Medical University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07739654
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 74
- From 18 Mar 2026 to the primary completion date, 20 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of investigational agents within 30 days prior to enrollment
- Concurrent anti-cancer treatments (chemotherapy, radiotherapy) during study period
Other illness
- History of other malignancies within last 5 years (except non-melanoma skin cancer or localized prostate cancer)
- Significant uncontrolled medical conditions (e.g., cardiovascular disease, uncontrolled diabetes)
- Known severe allergic reactions to DHAP components (dexamethasone, cytarabine, cisplatin)
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Hospital Coordinator of this site? Confirm its status | Lahore | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.