NCT07739654 Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
| NCT ID | NCT07739654 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | King Edward Medical University |
| Condition | DLBCL - Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2027-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 74 participants in total. It began in 2026-03-18 with a primary completion date of 2027-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Inbsaat Iqbal, MBBS, MD
STUDY DIRECTOR
King Edward Medical University
Frequently Asked Questions
Who can join the NCT07739654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DLBCL - Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07739654 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 74 participants.
Is NCT07739654 currently recruiting?
Yes, NCT07739654 is actively recruiting participants. Contact the research team at inbsatiqbal56@gmail.com for enrollment information.
Where is the NCT07739654 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07739654 clinical trial?
NCT07739654 is sponsored by King Edward Medical University. The principal investigator is Inbsaat Iqbal, MBBS, MD at King Edward Medical University. The trial plans to enroll 74 participants.