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

NCT03892421 | Completed Phase 1

• 1 other identifier: R-2018-3501-014
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  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

  63 days

Secondary Outcomes (2)

• Overall Survival

  12 months

• Progression Free Survival

  12 months

Study Arms (1)

Modified DHAP

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Cytarabine Injection; Drug: Dexamethasone; Drug: Filgrastim 0.3 MG/ML

Interventions

Rituximab DRUG

Rituximab 375 mg/m²

Also known as: MabThera

Modified DHAP

Carboplatin DRUG

Carboplatin AUC5

Modified DHAP

Cytarabine Injection DRUG

Cytarabine 2000 mg/m² qd 2 days

Modified DHAP

Dexamethasone DRUG

Dexamethasone 40 mg

Modified DHAP

Filgrastim 0.3 MG/ML DRUG

One subcutaneous injection daily for 5 days

Also known as: Neupogen

Modified DHAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• La Raza Medical Center: lead

Study Sites (1)

Hospital Especialidades Centro Medico La Raza

Mexico City, Azcapotzalco, 02990, Mexico

Location

Related Publications (4)

• 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.

  PMID: 3334893 BACKGROUND

• 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.

  PMID: 23919448 BACKGROUND

• 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. doi: 10.1177/40.5.1573252.

  PMID: 1573252 BACKGROUND

• 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.

  PMID: 18618501 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Carboplatin; Cytarabine; Dexamethasone; Filgrastim

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Study Officials H Caballero, MD Ms

  Hematology Department La Raza Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 27, 2019
• Study Start: April 5, 2018
• Primary Completion: January 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)