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Glucarpidase, methotrexate, R-CHOP for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Adolfo De la Fuente, PD

Research Sponsored by Fundacion CRIS de Investigación para Vencer el Cáncer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15min, 6 hours, 12 hours, 24 hours

Awards & highlights

Approved for 30 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

Diffuse large B-cell lymphoma (DLBCL) is an aggressive subset of non-Hodgkin's lymphoma (NHL). Central nervous system (CNS) involvement in patients with NHL is a serious complication. The outcome of patients with CNS relapse is extremely poor, with a median survival of 4-6 months. One approach to reduce CNS relapse in high-risk patients is the use of systemic high-dose intravenous (iv) methotrexate (HMTX) chemotherapy. Currently available methods of MTX clearance, including dialysis-based methods, have shown limited efficacy. Glucarpidase hydrolyses MTX to inactive metabolites that are partially metabolised by the liver, thus providing an alternative route of limiting renal excretion. The administration of Glucarpidase could prevent MTX toxicity as a whole as well as the following consequences. The aim of this study is to analyse the prophylactic effect of 2,000 units of glucarpidase administered after 12 hours of HDMTX on MTX clearance and on the incidence and severity of MTX-related toxicity.

Eligible Conditions

Therapeutic Agent Toxicity
Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15min, 6 hours, 12 hours, 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15min, 6 hours, 12 hours, 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15min, 6 hours, 12 hours, 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who achieve significant change blood MTX levels (more than 95% reduction of blood MTX levels) at 6 hours after administration of Glucarpidase

Secondary study objectives

Change blood MTX levels achieved at 15 minutes, 6 hours, 12 hours and 24 hours after administration of Glucarpidase

Glucarpidase

Proportion of patients with more than 95% reduction of blood MTX levels after administration of Glucarpidase

Awards & Highlights

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Glucarpidase, methotrexate, R-CHOPExperimental Treatment1 Intervention

Glucarpidase 2000Units per dose. IV. Bolus injection over 5 minutes. Administered 12 hours following after each HDMTX cycle, for a maximum of 3 cycles.

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