A Phase 3 interventional study of Cisplatin (modified schedule) and Cisplatin in DLBCL - Diffuse Large B Cell Lymphoma, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by King Edward Medical University · Phase 3, Interventional, and Treatment
Among 10 studies testing cytarabine in Lymphoma, B-Cell — 1 open to participants now, 1 under way, 1 of them phase 3. Cytarabine · Lymphoma, B-Cell.
Among the 10 studies testing cytarabine in Lymphoma, B-Cell, this one is the 3rd largest by planned enrollment, is the only one that started in 2026, is one of 2 in phase 3, and was the 10th registered.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 74 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →1 of the 10 studies testing cytarabine in Lymphoma, B-Cell is open now, in 1 country. Each count lists the studies.
Cytarabine: first FDA approval 1969 (CYTARABINE), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
Median enrollment 40 across the 10 interventional studies. Of the 8 that completed or were terminated, 5 (63%) have results posted.
None of the 10 has an industry lead sponsor. The 9 most frequent:
King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
King Edward Medical University has 1 study filed under Lymphoma, B-Cell — fewer than ten, so there is no comparison to draw.
1 of the studies testing cytarabine in Lymphoma, B-Cell that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07739654Phase 3King Edward Medical UniversityModified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma. | 2027-05-20 |
Among the 10 studies testing cytarabine in Lymphoma, B-Cell, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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):
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (modified schedule) · Drug: Dexametasone · Drug: Cytarabine (Ara-C) (Modified schedule)
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 · Drug: Dexametasone · Drug: Cytarabine (Ara-C)
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.
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.
The standard dexamethasone dosing regimen per RECIL 2017 criteria
Also known as: Dexa
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.
Also known as: Ara-C
The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Progressive Disease
* \>20% increase in the sum of longest diameters of target lesions * For small lymph nodes (\<15 mm post-therapy), a minimum absolute increase of 5 mm and long diameter \>15 mm is required * Appearance of new lesions automatically qualifies as PD * Any FDG-PET finding consistent with progression * Bone marrow involvement may persist or newly appear
Time frame: From enrollment to the end of treatment at 12 weeks
Progression free Survival (PFS)
the time from randomization (or study entry) until objective disease progression or death from any cause, whichever occurs first as assessed using standardized tumor response criteria (RECIL)
Time frame: From enrollment to up to 2 years post-treatment
Quality of Life (QoL)
Quality of Life (QoL) defined and measured by EORTC QLQ-C30, a standardized, cancer-specific questionnaire developed by the European Organization for Research and Treatment of Cancer.
Time frame: at the end of treatment at 12 weeks
Adverse Events
Adverse events graded as per CTCAE version 5.0 * Haematological: anaemia, neutropenia, and thrombocytopenia * Non-haematological: renal dysfunction, hepatotoxicity, mucositis, nausea, and neuropathy
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: No — IPD will not be shared but could be provided by the principal investigator (PI) up on reasonable request
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for May 2027, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Cisplatin · Cytarabine
King Edward Medical University