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A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma

NCT02532192 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-01-06

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of belinostat that can be combined with standard chemotherapy drugs (rituximab, cisplatin, cytarabine, and dexamethasone) in patients with relapsed or refractory DLBCL who are eligible for an autologous stem cell transplant (a transplant of the patient's own stem cells). The safety of the study drug will also be studied.

Conditions

Interventions

DRUG

Belinostat

Dose Escalation Phase Starting Dose: 200 mg/m2/d by vein on Days 1 and 2 of a 21 day cycle. Dose Expansion Starting Dose: Maximum tolerated dose from Dose Escalation Phase.

DRUG

Rituximab

Dose Escalation and Dose Expansion Phases: 375 mg/m2 by vein on Day 2 of a 21 day cycle.

DRUG

Cisplatin

Dose Escalation and Dose Expansion Phases: 100 mg/m2 by vein on Day 2 of a 21 day cycle

DRUG

Cytarabine

Dose Escalation Phase: 2 g/m2 by vein on Day 3 of a 21 day cycle. Two doses given every 12 hours. Dose Expansion Phase: 2g/m2 by vein on Day 2 of a 21 day cycle. Two doses given every 12 hours.

DRUG

Dexamethasone

Dose Escalation and Dose Expansion Phases: 40 mg by mouth on Days 2 - 5 of a 21 day cycle.

DRUG

Ciprofloxacin

500 mg by mouth twice daily for 10 days.

DRUG

Fluconazole

100 mg by mouth daily for 10 days.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jason R. Westin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532192 on ClinicalTrials.gov