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

NCT07739654 | Recruiting Phase 3 DMC

• 1 other identifier: KEMU-IRB-77-RC-2026
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Keywords

DLBCL; DHAP; B cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response rate (ORR)

  The Overall Response Rate (ORR) is defined as the percentage of patients achieving either a Complete Response (CR) or a Partial Response (PR), assessed according to RECIL 2017 criteria. * Complete Response (CR): * Disappearance of all target lesions * Lymph nodes \<10 mm * Normalization of FDG-PET (Deauville 1-3) * No bone marrow involvement, no new lesions * Partial Response (PR): * ≥30% decrease in the sum of longest diameters of target lesions * FDG-PET positive (Deauville 4-5) * May still have bone marrow involvement * No new lesions

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (7)

• Complete Response (CR)

  From enrollment to the end of treatment at 12 weeks

• Partial Response (PR)

  From enrollment to the end of treatment at 12 weeks

• Minor Response (MR)

  From enrollment to the end of treatment at 12 weeks

• Stable Disease

  From enrollment to the end of treatment at 12 weeks

• Progressive Disease

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Modified DHAP

EXPERIMENTAL

Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 50 mg/m² over 6 hours days 1-2; Cytarabine 2 g/m² IV over 3 hours days 1-2.

Drug: Cisplatin

standard DHAP

ACTIVE COMPARATOR

Dexamethasone 40 mg PO/IV days 1-4; Cisplatin 100 mg/m² continuous infusion over 24 hours day 1; Cytarabine 2×2 g/m² IV over 3 hours day 2.

Drug: Cisplatin

Interventions

Cisplatin DRUG

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, and cytarabine is administered over two consecutive days.

Also known as: dexamethasone, Cytarabine

Modified DHAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating; Lymphoma, B-Cell

Interventions

Cisplatin; Dexamethasone; Cytarabine

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Inbsaat Iqbal, MBBS, MD

  King Edward Medical University

  STUDY DIRECTOR

Central Study Contacts

Inbsaat Iqbal, MBBS, MD

CONTACT

+923099533745; inbsatiqbal56@gmail.com

Hafiz Muhammad Ehsan Arshad, MBBS

CONTACT

+923349830727; ehsanarshadch@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology and Radiotherapy

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)