NCT03892421

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: La Raza Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Non Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375 mg/m²
DRUG	Carboplatin	Carboplatin AUC5
DRUG	Cytarabine Injection	Cytarabine 2000 mg/m² qd 2 days
DRUG	Dexamethasone	Dexamethasone 40 mg
DRUG	Filgrastim 0.3 MG/ML	One subcutaneous injection daily for 5 days

Timeline

• Start date: 2018-04-05
• Primary completion: 2021-01-30
• Completion: 2021-04-30
• First posted: 2019-03-27
• Last updated: 2021-05-18

Locations

1 site across 1 country: Mexico