Relapsed Non Hodgkin LymphomaPhase 1/2NCT03892421
Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase 1/2 study testing Rituximab, Carboplatin and Cytarabine Injection in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by La Raza Medical Center at 1 site in Mexico.
Trial summary
The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- What is being tested?
- Rituximab, Carboplatin and Cytarabine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- 5 Apr 2018to 30 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent or refractory B-cell non-Hodgkin lymphoma
- Performance status: Eastern Cooperative Oncology Group 0-2
- At least three weeks from last chemotherapy
- Toxicities by Common Terminology Criteria Version 4.0 ≤ 1
- Glomerular filtration rate >50 ml/min
- Women of childbearing potential must use effective methods of contraception
Who cannot join
- Post-transplant relapse of lymphoma
- Central nervous system involvement of lymphoma
- Serious infections
- Known allergies to one or more of the experimental drugs
- Diabetes with glucose >200 mg/dl
- Pregnant or lactating females
- Known HIV or B Hepatitis positivity
- Known allergies to filgrastim
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Especialidades Centro Medico La Raza
Mexico City, Azcapotzalco, 02990
About this study
Official title: Safety and Efficacy of an Outpatient Schedule of Rituximab, Cytarabine, Carboplatin, and Dexamethasone in Relapsed/Refractory Non-Hodgkin Lymphoma. Phase I/II Trial.
The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting.
Read the detailed description
The R-DHAP (Rituximab, Dexamethasone, Cytarabine, and Cisplatin) schedule includes high-dose cytarabine every 12 hours and requires careful monitoring of renal toxicity because of cisplatin. These conditions limit the use of this protocol in an outpatient setting.
The S phase of lymphoma cells is longer than 12 hours, then cytarabine can be used daily without reduction of the antineoplastic effect. Carboplatin does not have remarkable renal toxicity so is not necessary to monitor blood chemistry or IV fluids during its administration.
The study hypothesis is that modifications to the original R-DHAP protocol, using cytarabine on a daily basis and the substitution of cisplatin by carboplatin can preserve the efficacy, reducing the incidence of renal events. The investigators hypothesize that those modifications can make the schedule more suitable for an outpatient administration in relapsed or refractory non-Hodgkin lymphoma patients.
After 3 cycles of chemotherapy, the overall response and the incidence of adverse events will be evaluated.
In order to achieve the purpose of this trial, 130 participants will be included.
- Being tested
- Rituximab, Carboplatin, Cytarabine Injection, Dexamethasone, Filgrastim 0.3 MG/ML
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called MabThera
Rituximab 375 mg/m²
CarboplatinDrug
Carboplatin AUC5
Cytarabine InjectionDrug
Cytarabine 2000 mg/m² qd 2 days
DexamethasoneDrug
Dexamethasone 40 mg
Filgrastim 0.3 MG/MLDrug
Also called Neupogen
One subcutaneous injection daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Modified DHAP | Experimental | Rituximab 375 mg/m² day 1, i.v. Carboplatin AUC(Area Under Curve) 5 day 1, i.v. Cytarabine 2000 mg/m², on day 2 and 3, i.v. Dexamethasone 40 mg, days 1-4, i.v. Filgrastim 300 mcg, days 10-15, s.c. Receives: Drug: Rituximab; Drug: Carboplatin; Drug: Cytarabine Injection; Drug: Dexamethasone; Drug: Filgrastim 0.3 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The percentage of patients which showed either a partial remission (PR), or a complete remission (CR) after study treatment.
Measured: 63 days
Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0
Measured: 63 days
Secondary outcomes (2)
Overall Survival
Measured: 12 months
Progression Free Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start5 Apr 2018
- Primary completion30 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsed Non Hodgkin 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Raza Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Hernandez Caballero MD MS, La Raza Medical Center
- Investigators
- Study Officials H Caballero, MD Ms, Principal investigator, Hematology Department La Raza Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892421
- Sponsor's protocol ID
- R-2018-3501-014
- Status last verified
- May 2021
- First submitted
- 24 Mar 2019
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Velasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22.
PubMed 3334893Momparler RL. Optimization of cytarabine (ARA-C) therapy for acute myeloid leukemia. Exp Hematol Oncol. 2013 Aug 6;2:20. doi: 10.1186/2162-3619-2-20. eCollection 2013.
PubMed 23919448Yanik G, Yousuf N, Miller MA, Swerdlow SH, Lampkin B, Raza A. In vivo determination of cell cycle kinetics of non-Hodgkin's lymphomas using iododeoxyuridine and bromodeoxyuridine. J Histochem Cytochem. 1992 May;40(5):723-8. doi: 10.1177/40.5.1573252.
PubMed 1573252Sandlund JT, Santana VM, Hudson MM, Onciu M, Head D, Murry DJ, Ribeiro R, Wallace D, Rencher R, Pui CH. Combination of dexamethasone, high-dose cytarabine, and carboplatin is effective for advanced large-cell non-Hodgkin lymphoma of childhood. Cancer. 2008 Aug 15;113(4):782-90. doi: 10.1002/cncr.23630.
PubMed 18618501
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Outpatient Schedule of Rituximab, Cytarabine, Carboplatin, and Dexamethasone in Relapsed/Refractory Non-Hodgkin Lymphoma. Phase I/II Trial.
- ClinicalTrials.gov ID
- NCT03892421
- Acronym / sponsor ID
- R-2018-3501-014
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- La Raza Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Mar 2019 (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 goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting.
Detailed description
The R-DHAP (Rituximab, Dexamethasone, Cytarabine, and Cisplatin) schedule includes high-dose cytarabine every 12 hours and requires careful monitoring of renal toxicity because of cisplatin. These conditions limit the use of this protocol in an outpatient setting.
The S phase of lymphoma cells is longer than 12 hours, then cytarabine can be used daily without reduction of the antineoplastic effect. Carboplatin does not have remarkable renal toxicity so is not necessary to monitor blood chemistry or IV fluids during its administration.
The study hypothesis is that modifications to the original R-DHAP protocol, using cytarabine on a daily basis and the substitution of cisplatin by carboplatin can preserve the efficacy, reducing the incidence of renal events. The investigators hypothesize that those modifications can make the schedule more suitable for an outpatient administration in relapsed or refractory non-Hodgkin lymphoma patients.
After 3 cycles of chemotherapy, the overall response and the incidence of adverse events will be evaluated.
In order to achieve the purpose of this trial, 130 participants will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified DHAP | Experimental | Drug: Rituximab, Drug: Carboplatin, Drug: Cytarabine Injection, Drug: Dexamethasone, Drug: Filgrastim 0.3 MG/MLRituximab 375 mg/m² day 1, i.v. Carboplatin AUC(Area Under Curve) 5 day 1, i.v. Cytarabine 2000 mg/m², on day 2 and 3, i.v. Dexamethasone 40 mg, days 1-4, i.v. Filgrastim 300 mcg, days 10-15, s.c. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of recurrent or refractory B-cell non-Hodgkin lymphoma
- Performance status: Eastern Cooperative Oncology Group 0-2
- At least three weeks from last chemotherapy
- Toxicities by Common Terminology Criteria Version 4.0 ≤ 1
- Glomerular filtration rate >50 ml/min
Key exclusion criteria (8 listed)
- Post-transplant relapse of lymphoma
- Central nervous system involvement of lymphoma
- Serious infections
- Known allergies to one or more of the experimental drugs
- Diabetes with glucose >200 mg/dl
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 |
|---|---|---|
| RituximabAlso: MabTheraRituximab 375 mg/m² | Drug | Modified DHAP |
| CarboplatinCarboplatin AUC5 | Drug | Modified DHAP |
| Cytarabine InjectionCytarabine 2000 mg/m² qd 2 days | Drug | Modified DHAP |
| DexamethasoneDexamethasone 40 mg | Drug | Modified DHAP |
| Filgrastim 0.3 MG/MLAlso: NeupogenOne subcutaneous injection daily for 5 days | Drug | Modified DHAP |
Primary outcome
Overall Response Rate
Time frame: 63 days
The percentage of patients which showed either a partial remission (PR), or a complete remission (CR) after study treatment.
Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0
Time frame: 63 days
2 secondary outcomes
Overall Survival
Time frame: 12 months
Progression Free Survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 3334893Velasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22.
- Background: PubMed 23919448Momparler RL. Optimization of cytarabine (ARA-C) therapy for acute myeloid leukemia. Exp Hematol Oncol. 2013 Aug 6;2:20. doi: 10.1186/2162-3619-2-20. eCollection 2013.
- Background: PubMed 1573252Yanik G, Yousuf N, Miller MA, Swerdlow SH, Lampkin B, Raza A. In vivo determination of cell cycle kinetics of non-Hodgkin's lymphomas using iododeoxyuridine and bromodeoxyuridine. J Histochem Cytochem. 1992 May;40(5):723-8. doi: 10.1177/40.5.1573252.
- Background: PubMed 18618501Sandlund JT, Santana VM, Hudson MM, Onciu M, Head D, Murry DJ, Ribeiro R, Wallace D, Rencher R, Pui CH. Combination of dexamethasone, high-dose cytarabine, and carboplatin is effective for advanced large-cell non-Hodgkin lymphoma of childhood. Cancer. 2008 Aug 15;113(4):782-90. doi: 10.1002/cncr.23630.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Study Officials H Caballero, MD Ms principal investigator
Hematology Department La Raza Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituximab, Carboplatin and Cytarabine Injection in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by La Raza Medical Center at 1 site in Mexico.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 18 May 2021. 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 Mexico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 63 days). The study lists 2 primary outcomes in all. 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 NCT03892421, which also lists 4 linked publications.
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 18 May 2021.