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MLN4924 Compared With MLN4924 Plus Chemotherapy for Large B-cell Lymphoma

NCT01415765 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

\- MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective in treating some cases of large B-cell lymphoma. This research will look at two things. The first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell lymphoma.

Objectives:

* To study how MLN4924 affects large B-cell lymphoma tumors.
* To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R chemotherapy.

Eligibility:

\- Individuals at least 18 years of age who have large B-cell lymphoma that will be treated with chemotherapy.

Design:

* Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, tumor samples, and imaging studies.
* Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest period. Participants will be monitored with frequent blood tests and imaging studies.
* Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R chemotherapy for up to six cycles of treatment.

Conditions

  • Lymphoma, Diffuse Large-Cell B-cell
  • Diffuse, Large B-cell Lymphoma
  • Lymphoma, Diffuse Large-Cell
  • Large-Cell Lymphoma, Diffuse

Interventions

DRUG

MLN4924

Part A: 150mg/m2 IV (in the vein) on days 1,4,7,11 of each 21 day cycle Part B: variable dose levels IV on days 1,5 each 21 day cycle

DRUG

Etoposide

CIV(continuous intravenous infusion) on days 1-4 of every 21 day cycle

DRUG

Prednisone

PO (by mouth) twice daily on days 1-5 of every 21 day cycle

DRUG

Vincristine

CIV on days 1-4 of every 21 day cycle

DRUG

Cyclophosphamide

IV on day 5 of each 21 day cycle

DRUG

Doxorubicin

CIV on days 1-4 of each 21 day cycle

DRUG

Rituximab

IV on day 1 of each 21 day cycle

DRUG

Filgrastim

Subcutaneously beginning Day 6 of each 21 day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Wyndham H Wilson, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-07-15
Primary Completion
2014-01-07
Completion
2014-01-07

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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 NCT01415765 on ClinicalTrials.gov