SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma (NCT00787527) | Clinical Trial Compass
CompletedPhase 1/2
SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma
United States14 participantsStarted 2008-11
Plain-language summary
The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.
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 a new diagnosis of T-cell NHL eligible histologies include:Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma (ALK) (ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, intestinal T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
. Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk. A minimum of four cycles of therapy will be given before evaluation for to hematopoetic stem cell transplant.
. Patients must have biopsy proven disease which can include bone marrow and/or lymph node (cutaneous only disease is excluded)
. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
. Patients must be age 18 years old and above.There is no dosing or adverse event data are currently available on the use of vorinostat in patients \<18 years of age, children are excluded from this study but may be eligible for future pediatric phase 2 combination trials.
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
1
Phase I Maximum Tolerated Dose (MTD) of Vorinostat
Timeframe: 21 Days
2
Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
. There is Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) \>/= 1000/mm\^3, Platelets \>/= 50,000/mm3, Hemoglobin \>/= 8g/dL. If there is bone marrow involvement by lymphoma then there is no minimum level of counts required.
. Patients must have adequate liver function as indicated by: Bilirubin \</= 1.5 times the upper limit of normal (ULN), Alanine transaminase (ALT) \</=2 times the (ULN) or aspartate transaminase (AST) \</= 2 times the ULN. These values must be obtained within two weeks before protocol entry.
. Patients are required to have adequate renal function as indicated by a serum creatinine \</= 2.5 mg/dL. This value must be obtained within two weeks before protocol entry.
Exclusion criteria
. 1\. Patients with a) T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease b)T-cell prolymphocytic leukemia (T-PLL) c) T-cell large granular lymphocytic leukemia d) Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis e) Angiocentric/nasal type T/Natural Killer (NK)-cell lymphoma f) Hepatosplenic gamma-delta T-cell lymphoma
. Patients with active Hepatitis B and/or Hepatitis C infection.
. Patients with known HIV infection are excluded. a) These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy.
. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes:a) Congestive heart failure, b) Severe CAD, c) Cardiomyopathy, d) Uncontrolled cardiac arrhythmia, e) Unstable angina pectoris, f) Recent MI (within 6 months).
. Patients with prior exposure to either vorinostat (including other histone deacetylase (HDAC) inhibitors except valproic acid) or anthracyclines: a) Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
. Patients who are pregnant or breast-feeding. a)Effects of this treatment on the fetus and young children are unknown at this time.
. Patients who have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease.