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

May 15, 2021 updated by: Alvaro Hernandez Caballero MD MS, La Raza Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Azcapotzalco
      • Mexico City, Azcapotzalco, Mexico, 02990
        • Hospital Especialidades Centro Medico La Raza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified DHAP
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.
Drug: Rituximab
Rituximab 375 mg/m²
Other Names:
  • MabThera
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
Other Names:
  • Neupogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
63 days
Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0
Time Frame: 63 days
63 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 12 months
12 months
Progression Free Survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Raza Medical Center

Investigators

  • Principal Investigator: Study Officials H Caballero, MD Ms, Hematology Department La Raza Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

March 24, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2018-3501-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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