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

Refractory Non-Hodgkin Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892421
• Other study ID #: R-2018-3501-014
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 5, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: La Raza Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Refractory Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma

Intervention

Drug:
• Rituximab
Rituximab 375 mg/m²
• Carboplatin
Carboplatin AUC5
• Cytarabine Injection
Cytarabine 2000 mg/m² qd 2 days
• Dexamethasone
Dexamethasone 40 mg
• Filgrastim 0.3 MG/ML
One subcutaneous injection daily for 5 days

Locations

Country	Name	City	State
Mexico	Hospital Especialidades Centro Medico La Raza	Mexico City	Azcapotzalco

Sponsors (1)

Lead Sponsor	Collaborator
La Raza Medical Center

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Momparler RL. Optimization of cytarabine (ARA-C) therapy for acute myeloid leukemia. Exp Hematol Oncol. 2013 Aug 6;2:20. doi: 10.1186/2162-3619-2-20. eCollection 2013. — View Citation

Sandlund JT, Santana VM, Hudson MM, Onciu M, Head D, Murry DJ, Ribeiro R, Wallace D, Rencher R, Pui CH. Combination of dexamethasone, high-dose cytarabine, and carboplatin is effective for advanced large-cell non-Hodgkin lymphoma of childhood. Cancer. 2008 Aug 15;113(4):782-90. doi: 10.1002/cncr.23630. — View Citation

Velasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22. — View Citation

Yanik G, Yousuf N, Miller MA, Swerdlow SH, Lampkin B, Raza A. In vivo determination of cell cycle kinetics of non-Hodgkin's lymphomas using iododeoxyuridine and bromodeoxyuridine. J Histochem Cytochem. 1992 May;40(5):723-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	The percentage of patients which showed either a partial remission (PR), or a complete remission (CR) after study treatment.	63 days
Primary	Incidence of hematological toxicities > grade 2 by Common Terminology Criteria V4.0		63 days
Secondary	Overall Survival		12 months
Secondary	Progression Free Survival		12 months