Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma
NCT ID: NCT03892421
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2018-04-05
2021-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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La Raza Medical Center
OTHER
Responsible Party
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Alvaro Hernandez Caballero MD MS
Principal Investigator
Principal Investigators
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Study Officials H Caballero, MD Ms
Role: PRINCIPAL_INVESTIGATOR
Hematology Department La Raza Medical Center
Locations
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Hospital Especialidades Centro Medico La Raza
Mexico City, Azcapotzalco, Mexico
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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R-2018-3501-014
Identifier Type: -
Identifier Source: org_study_id
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