Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cisplatin, Cisplatin.
- Who it may be relevant to
- Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Effectiveness and Toxicities of Modified DHAP Protocol With Standard DHAP Protocol in Patients With Relapsed/Refractory Diffused Large B-cell Lymphoma.
Overview
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.
Detailed description
This study is a randomized controlled trial designed to compare the effectiveness and toxicity profile of a modified DHAP regimen versus the standard DHAP regimen in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
DLBCL is the most common subtype of non-Hodgkin lymphoma, with a significant proportion of patients experiencing relapse or refractory disease after initial therapy. The standard DHAP regimen (cisplatin, cytarabine, dexamethasone) has been widely used as salvage therapy, achieving response rates of up to 70%. However, its use is limited by severe toxicities, including renal dysfunction, infections, and profound myelosuppression.
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. This modification is hypothesized to reduce nephrotoxicity, improve tolerability, and allow outpatient administration, while maintaining or enhancing cytotoxic synergy between cisplatin and cytarabine.
A total of 74 patients will be enrolled and randomized into two arms (37 per arm):
* Arm A (Modified DHAP): 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. * Arm B (Standard DHAP): 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.
Primary endpoint: Overall response rate (ORR), defined as complete or partial response per RECIL 2017 criteria.
Secondary endpoints: Progression-free survival (PFS), toxicity incidence and severity graded by CTCAE, and quality of life (QoL) assessed using the EORTC QLQ-C30 questionnaire.
Patients will be followed for treatment response, adverse events, and QoL changes. Toxicities will be documented using CTCAE forms, with particular attention to hematological toxicities (anemia, neutropenia, thrombocytopenia) and non-hematological toxicities (renal dysfunction, hepatotoxicity, mucositis, neuropathy).
The study anticipates that the modified DHAP regimen will demonstrate comparable or superior efficacy with a reduced incidence of severe toxicities, shorter hospital stays, and improved patient satisfaction. If successful, this regimen could support the transition of DHAP into outpatient administration, optimizing healthcare resource utilization in Pakistan and improving access to therapy for patients with poor prognoses.
Interventions
- Drug Cisplatin
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. - Drug Cisplatin
The 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.
Primary outcome measures
- Overall Response rate (ORR) [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (7)
- Complete Response (CR) [Time frame: From enrollment to the end of treatment at 12 weeks]
- Partial Response (PR) [Time frame: From enrollment to the end of treatment at 12 weeks]
- Minor Response (MR) [Time frame: From enrollment to the end of treatment at 12 weeks]
- Stable Disease [Time frame: From enrollment to the end of treatment at 12 weeks]
- Progressive Disease [Time frame: From enrollment to the end of treatment at 12 weeks]
- Progression free Survival (PFS) [Time frame: From enrollment to the end of treatment at 12 weeks]
- Quality of Life (QoL) [Time frame: at the end of treatment at 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Mayo Hospital — Lahore
Identifiers
NCT: NCT07739654 · KEMU-IRB-77-RC-2026