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 range18 Years

SexALL

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.
✓. 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

What they're measuring

Phase I Maximum Tolerated Dose (MTD) of Vorinostat

Timeframe: 21 Days

Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat

Timeframe: 21 Days

Phase II MTD of Vorinostat

Timeframe: 21 Days

Trial details

NCT IDNCT00787527

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2014-09-02

View on ClinicalTrials.gov More Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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.
✓. 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.