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

Sponsor
La Raza Medical Center
Study ID
NCT03892421
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 5, 2018
Status verified
May 2021
Primary completion
Jan 30, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 63 days ]

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