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Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma

Safety and Efficacy of an Outpatient Schedule of Rituximab, Cytarabine, Carboplatin, and Dexamethasone in Relapsed/Refractory Non-Hodgkin Lymphoma. Phase I/II Trial.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03892421
Enrollment
22
Registered
2019-03-27
Start date
2018-04-05
Completion date
2021-04-30
Last updated
2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Non-Hodgkin Lymphoma, Relapsed Non Hodgkin Lymphoma

Brief 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.

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.

Interventions

DRUGRituximab

Rituximab 375 mg/m²

DRUGCarboplatin

Carboplatin AUC5

Cytarabine 2000 mg/m² qd 2 days

DRUGDexamethasone

Dexamethasone 40 mg

DRUGFilgrastim 0.3 MG/ML

One subcutaneous injection daily for 5 days

Sponsors

La Raza Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Overall Response Rate63 daysThe 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 V4.063 days

Secondary

MeasureTime frame
Overall Survival12 months
Progression Free Survival12 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026