DLBCL - Diffuse Large B Cell LymphomaPhase 3MOD-DHAPNCT07739654
Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.
A Phase 3 study testing Cisplatin (modified schedule), Cisplatin and Dexametasone in people with DLBCL - Diffuse Large B Cell Lymphoma, run by King Edward Medical University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- Cisplatin (modified schedule), Cisplatin and Dexametasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Mar 2026to 20 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital
Lahore, Punjab Province, 54000
Inbsaat Iqbal, MBBS, MD, 03099533745, inbsatiqbal56@gmail.com
inbsatiqbal56@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- Cisplatin (modified schedule), Cisplatin, Dexametasone, Cytarabine (Ara-C), Cytarabine (Ara-C) (Modified schedule)
- Keywords
- DLBCL, DHAP, B cell Lymphoma
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin (modified schedule)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.
CisplatinDrug
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.
DexametasoneDrug
Also called Dexa
The standard dexamethasone dosing regimen per RECIL 2017 criteria
Cytarabine (Ara-C)Drug
Also called Ara-C
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.
Cytarabine (Ara-C) (Modified schedule)Drug
The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cisplatin (modified schedule); Drug: Dexametasone; Drug: Cytarabine (Ara-C) (Modified schedule) |
| 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. Receives: Drug: Cisplatin; Drug: Dexametasone; Drug: Cytarabine (Ara-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start18 Mar 2026
- Primary completion20 May 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Khokhar, King Edward Medical University
- Investigators
- Inbsaat Iqbal, MBBS, MD, Study director, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739654
- Sponsor's protocol ID
- KEMU-IRB-77-RC-2026
- Acronym
- MOD-DHAP
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared but could be provided by the principal investigator (PI) up on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07739654
- Acronym / sponsor ID
- MOD-DHAP / KEMU-IRB-77-RC-2026
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- DLBCL, DHAP, B cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified DHAP | Experimental | Drug: Cisplatin (modified schedule), Drug: Dexametasone, Drug: Cytarabine (Ara-C) (Modified schedule)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. |
| standard DHAP | Active comparator | Drug: Cisplatin, Drug: Dexametasone, Drug: Cytarabine (Ara-C)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin (modified schedule)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. | Drug | Modified DHAP |
| CisplatinThe 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. | Drug | standard DHAP |
| DexametasoneAlso: DexaThe standard dexamethasone dosing regimen per RECIL 2017 criteria | Drug | Modified DHAP, standard DHAP |
| Cytarabine (Ara-C)Also: Ara-CThe 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. | Drug | standard DHAP |
| Cytarabine (Ara-C) (Modified schedule)The modified DHAP regimen alters the administration schedule of cisplatin and cytarabine. Cytarabine is administered over two consecutive days. | Drug | Modified DHAP |
Primary outcome
Overall Response rate (ORR)
Time frame: From enrollment to the end of treatment at 12 weeks
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
8 secondary outcomes
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 up to 2 years post-treatment
Quality of Life (QoL)
Time frame: at the end of treatment at 12 weeks
Adverse Events
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared but could be provided by the principal investigator (PI) up on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inbsaat Iqbal, MBBS, MD study director
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin (modified schedule), Cisplatin and Dexametasone in people with DLBCL - Diffuse Large B Cell Lymphoma, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inbsaat Iqbal, MBBS, MD (+923099533745, inbsatiqbal56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response rate (ORR) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.