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

Phase 1

Completed

• Conditions: Refractory Non-Hodgkin Lymphoma; Relapsed Non Hodgkin Lymphoma
• Interventions: Drug: Rituximab; Drug: Carboplatin; Drug: Cytarabine Injection; Drug: Dexamethasone; Drug: Filgrastim 0.3 MG/ML

• Registration Number: NCT03892421
• Lead Sponsor: La Raza Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-05
• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Primary Completion: 2021-01-30
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-15
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified DHAP	Cytarabine Injection	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.
Modified DHAP	Rituximab	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.
Modified DHAP	Dexamethasone	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.
Modified DHAP	Filgrastim 0.3 MG/ML	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.
Modified DHAP	Carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	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	63 days

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months
Progression Free Survival	12 months

Trial Locations

Locations (1)

Hospital Especialidades Centro Medico La Raza; 🇲🇽 Mexico City, Azcapotzalco, Mexico