NCT01235793: DRBEAT

The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma

Terminated Phase 2 Results posted Last updated 20 November 2018

What this trial tests

Phase 2 trial testing Temozolomide in B-Cell Lymphoma Originating in the CNS in 11 participants. Terminated before completion.

Timeline

14 October 2010

Primary endpoint
28 July 2017

18 April 2018

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	14 October 2010
Primary completion	28 July 2017
Estimated completion	18 April 2018
Sites	1 location across United States

Drugs / interventions tested

• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• B-Cell Lymphoma Originating in the CNS — all drugs for B-Cell Lymphoma Originating in the CNS →

Sponsor

Cedars-Sinai Medical Center

Who can join

Adults 18 to 75, any sex, with B-Cell Lymphoma Originating in the CNS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

One-year Progression-free Survival and Overall Survival Primary · (1) One Year (2) Until date of death from any cause, assessed up to 2 years

Efficacy of the DRBEAT Regimen will be assessed by analysis of 1. one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression\*, or death, (\*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.) and 2. Overall survival, defined as the time interval between the date of transplant and the date of death from any cause.

Progression Free Survival

Group	Value	95% CI
DRBEAT Regimen	132	38 – NA

Overall Survival

Group	Value	95% CI
DRBEAT Regimen	564	71 – NA

Safest Dose of Temozolomide for the DRBEAT Regimen Primary · One Year

Safety will be assessed using a dose escalation design for temozolomide's use to determine the target dose and also to evaluate any and all acute treatment related toxicities. During the course of patient follow up and therapy, toxicities will be evaluated, particularly as the investigators will be determining the target dose of temozolomide. One of the major criteria for dose limiting toxicity for the study will be any Grade 3 or 4 nonhematologic toxicity from a list of commonly expected toxicities associated with autologous transplantation and temozolomide.

Group	Value	95% CI
DRBEAT Regimen	773.25	496.38 – 1000

Adverse events — posted to ClinicalTrials.gov

Time frame: Over a two year period, from start of research therapy to 2 years post treatment.. Reporting threshold: 05%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DRBEAT Regimen

Serious: 6/11 (55%)

Deaths: 6/11

Serious adverse events (5 terms)

Reaction	System	DRBEAT Regimen
Sepsis	Infections and infestations	—
Encephalopathy	Nervous system disorders	—
Febrile Neutropenia	Blood and lymphatic system disorders	—
Gait disturbances	Nervous system disorders	—
Renal and Urinary disorders -Other, specify: High squamous epithelial cells	Renal and urinary disorders	—

Other adverse events (27 terms — click to expand)

Reaction	System	DRBEAT Regimen
Febrile neutropenia	Blood and lymphatic system disorders	—
Platelet count decreased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
White blood cell decreased	Investigations	—
Lymphocyte count decreased	Investigations	—
Neutrophil count decreased	Investigations	—
Urinary tract infection	Renal and urinary disorders	—
Blood bilirubin increased	Investigations	—
Fatigue	General disorders	—
Hypophosphatemia	Metabolism and nutrition disorders	—
Alanine aminotransferase increased	Investigations	—
Alkaline phosphatase increased	Investigations	—
Allergic reaction	Immune system disorders	—
Aspartate aminotransferase increased	Investigations	—
Blood and lymphatic disorders -Other, specify: Pancytopenia	Blood and lymphatic system disorders	—
Facial muscle weakness	Musculoskeletal and connective tissue disorders	—
Hypertryglyceridemia	Metabolism and nutrition disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Hypotension	Vascular disorders	—
Infections and infestations -Other, specify: Ecoli bacteria	Infections and infestations	—
Leukocytosis	Blood and lymphatic system disorders	—
Lung infection	Infections and infestations	—
Mucositis oral	Gastrointestinal disorders	—
Musculoskeletal and connective tissue disorders -Other, specify: Neck weakness	Musculoskeletal and connective tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Somnolence	Nervous system disorders	—
Urinary incontinence	Renal and urinary disorders	—

Most-reported serious reactions: Sepsis, Encephalopathy, Febrile Neutropenia, Gait disturbances, Renal and Urinary disorders -Other, specify: High squamous epithelial cells.

Data from ClinicalTrials.gov NCT01235793 adverse events section.

Sponsor's own description

The primary purpose of the study will be testing the dosing of temozolomide to find the target dose that a person can tolerate. The other part of the study will be determining how helpful it can be to CNS lymphoma patients by adding temozolomide to the "conditioning regimen" prior to stem cell transplantation.

This research study is designed to test the investigational use of temozolomide as part of a conditioning regimen prior to stem cell transplantation. This drug has not yet been approved by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell transplantation in lymphomas of the brain (central nervous system or CNS) but it has been studied and used before in transplantation with reasonable results.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.