Modified DHAP vs Standard DHAP in relapsed/refractory DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase III study compares a modified DHAP regimen (fractionated cisplatin and two-day cytarabine) to the standard DHAP regimen in adults with relapsed or refractory diffuse large B-cell lymphoma. The trial aims to see if the modified schedule maintains response while reducing nephrotoxicity and other toxicities, potentially enabling outpatient treatment. Primary endpoint is overall response rate by RECIL 2017 criteria; secondary endpoints include progression-free survival, adverse events by CTCAE, and quality of life. A total of 74 participants (37 per arm) will be enrolled across participating centers, with eligibility focused on adults with prior lymphoma therapy, adequate organ function, and good performance status.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Hospital
  Lahore, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Inbsaat Iqbal, MBBS, MD
• Email: inbsatiqbal56@gmail.com
• Phone: +923099533745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.