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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892421
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Alvaro Hernandez Caballero MD MS, La Raza Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsed Non Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Drug: Rituximab Drug: Carboplatin Drug: Cytarabine Injection Drug: Dexamethasone Drug: Filgrastim 0.3 MG/ML Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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 Name: 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 Name: Neupogen


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0 [ Time Frame: 63 days ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months ]
  2. Progression Free Survival [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892421


Locations
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Mexico
Hospital Especialidades Centro Medico La Raza
Mexico City, Azcapotzalco, Mexico, 02990
Sponsors and Collaborators
La Raza Medical Center
Investigators
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Principal Investigator: Study Officials H Caballero, MD Ms Hematology Department La Raza Medical Center
More Information
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Publications:

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Responsible Party: Alvaro Hernandez Caballero MD MS, Principal Investigator, La Raza Medical Center
ClinicalTrials.gov Identifier: NCT03892421    
Other Study ID Numbers: R-2018-3501-014
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Rituximab
Carboplatin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immunologic Factors
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents