LymphomaPhase 3NCT03647072
PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
A Phase 3 study testing CHOP, CHOP Plus Lanzoprazole and CHOP Plus Famotidine in people with Lymphoma, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- CHOP, CHOP Plus Lanzoprazole and CHOP Plus Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to Dec 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
- DLBCL Lymphoma subtype --No comorbid disease
Who cannot join
- Pregnancy
- Peptic ulcer
- Severe cardiac disease
- Osteoporosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Comparative Clinical and Biochemical Study Evaluating the Effect of Proton Pump I Nhibitors Versus Histamine 2 Receptor Antagonists as an Adjuvant With Chemotherapy in Patients With Non-hodgkin Lymphoma.
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.
Read the detailed description
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.
- Conditions
- Lymphoma
- Being tested
- CHOP, CHOP Plus Lanzoprazole, CHOP Plus Famotidine
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOPDrug
Also called CHOP protocol
CHOP only
CHOP Plus LanzoprazoleDrug
Also called CHOP Plus Lanzoprazole 60
CHOP plus Lanzoprazole 60 mg
CHOP Plus FamotidineDrug
Also called CHOP Plus Famotidine 40
CHOP Plus Famotidine 40 mg
| Study group | Role | What they receive |
|---|---|---|
| CHOP | Active comparator | CHOP only Receives: Drug: CHOP |
| CHOP Plus Lanzoprazole | Active comparator | CHOP Plus Lanzoprazole 60 mg Receives: Drug: CHOP Plus Lanzoprazole |
| CHOP Plus Famotidine | Active comparator | CHOP Plus Famotidine 40 mg Receives: Drug: CHOP Plus Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients eith radiological and clinical improvement
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Aug 2018
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Sahar K Hegazy, Prof, Principal investigator, Clinical pharmacy Department- Tanta UniversitySahar M El-Haggar, prof, Study director, Clinical pharmacy Department- Tanta UniversitySuzan A Alhassanin, Ph D, Study director, Clinical Oncology Department-Menoufia UniversityEman I A El berri, Msc, Principal investigator, Clinical pharmacy Department-Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647072
- Sponsor's protocol ID
- eman elberry
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hegazy SK, El-Haggar SM, Alhassanin SA, El-Berri EI. Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma. Med Oncol. 2021 Jan 4;38(1):4. doi: 10.1007/s12032-020-01452-z.
PubMed 33394214
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Biochemical Study Evaluating the Effect of Proton Pump I Nhibitors Versus Histamine 2 Receptor Antagonists as an Adjuvant With Chemotherapy in Patients With Non-hodgkin Lymphoma.
- ClinicalTrials.gov ID
- NCT03647072
- Acronym / sponsor ID
- eman elberry
- Conditions
- Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Aug 2018 (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.
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.
Detailed description
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHOP | Active comparator | Drug: CHOPCHOP only |
| CHOP Plus Lanzoprazole | Active comparator | Drug: CHOP Plus LanzoprazoleCHOP Plus Lanzoprazole 60 mg |
| CHOP Plus Famotidine | Active comparator | Drug: CHOP Plus FamotidineCHOP Plus Famotidine 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DLBCL Lymphoma subtype --No comorbid disease
Key exclusion criteria (4 listed)
- Pregnancy
- Peptic ulcer
- Severe cardiac disease
- Osteoporosis
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 |
|---|---|---|
| CHOPAlso: CHOP protocolCHOP only | Drug | CHOP |
| CHOP Plus LanzoprazoleAlso: CHOP Plus Lanzoprazole 60CHOP plus Lanzoprazole 60 mg | Drug | CHOP Plus Lanzoprazole |
| CHOP Plus FamotidineAlso: CHOP Plus Famotidine 40CHOP Plus Famotidine 40 mg | Drug | CHOP Plus Famotidine |
Primary outcome
Number of patients eith radiological and clinical improvement
Time frame: 6 months
Number of patients eith radiological and clinical improvement after cycles of chemotherapy
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 27 Aug 2018.
- Derived from this study: PubMed 33394214Hegazy SK, El-Haggar SM, Alhassanin SA, El-Berri EI. Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma. Med Oncol. 2021 Jan 4;38(1):4. doi: 10.1007/s12032-020-01452-z.
- Individual participant dataSharing planned: Undecided
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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.
Sahar K Hegazy, Prof principal investigator
Clinical pharmacy Department- Tanta University
Sahar M El-Haggar, prof study director
Clinical pharmacy Department- Tanta University
Suzan A Alhassanin, Ph D study director
Clinical Oncology Department-Menoufia 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 CHOP, CHOP Plus Lanzoprazole and CHOP Plus Famotidine in people with Lymphoma, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 1 inclusion and 4 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 27 Aug 2018. 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 Egypt. 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 Sherief Abd-Elsalam, MD (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients eith radiological and clinical improvement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03647072, which also lists 1 linked publication.
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 27 Aug 2018.