TerminatedPhase 2

Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Stopped: Terminated due to slow accrual.

United States1 participantsStarted 2009-01

Plain-language summary

Primary Objectives: 1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib 2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL. Secondary Objectives: 1. To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib. 2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
. Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
. Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
. Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Response

Timeframe: Every two 21-day cycles

Trial details

NCT IDNCT00810576

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

Results submitted2010-06-11

View on ClinicalTrials.gov More Lymphoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
. Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
. Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
. Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.

Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria