Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Edward Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Histologically confirmed relapsed or refractory DLBCL
Adults ≥ 18 years
At least one prior line of therapy for lymphoma
ECOG performance status 0-2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cisplatin (modified schedule)
DrugThe 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
DrugThe 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
DrugThe standard dexamethasone dosing regimen per RECIL 2017 criteria
Cytarabine (Ara-C)
DrugThe 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)
DrugThe modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Modified DHAPExperimental treatment 3 interventions
Group B: standard DHAPActive comparator 3 interventions
Trial outcomes
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
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Complete Response (CR)
* 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
Time frame
From enrollment to the end of treatment at 12 weeks2
Partial Response (PR)
* 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
Time frame
From enrollment to the end of treatment at 12 weeks3
Minor Response (MR)
* ≥10% decrease in the sum of longest diameters of target lesions, but not enough to qualify as PR (≥30%) * FDG-PET may still show uptake (any finding) * Bone marrow involvement may persist * No new lesions
Time frame
From enrollment to the end of treatment at 12 weeks4
Stable Disease
* \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions * FDG-PET findings may remain positive * Bone marrow involvement may persist * No new lesions
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov