Trial · NCT00787527

SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

NCT00787527, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2014-09-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma. Trials, record NCT00787527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00787527

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma
NCT number: NCT00787527
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 14 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Lymphoma
Interventions: Zolinza (vorinostat), Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
First posted: 2008-11-07
Last updated: 2014-09-09
Results first posted: 2014-09-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase I Maximum Tolerated Dose (MTD) of Vorinostat	21 Days	MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
Primary	Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat	21 Days	MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.
Primary	Phase II MTD of Vorinostat	21 Days	MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Phase I Maximum Tolerated Dose (MTD) of Vorinostat	21 Days	mg/day	NUMBER
PRIMARY	Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat	21 Days	participants	NUMBER
PRIMARY	Phase II MTD of Vorinostat	21 Days	mg/three times daily	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Phase I Maximum Tolerated Dose (MTD) of Vorinostat	Schedule A - Vorinostat Once or Twice Daily	300	mg/day
Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat	Schedule A - Vorinostat Once Daily	1	participants
Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat	Schedule A - Vorinostat Twice Daily	2	participants
Phase II MTD of Vorinostat	Schedule B - Vorinostat Three Times Daily	300	mg/three times daily

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zolinza + CHOP	14
Overall Study	COMPLETED	Zolinza + CHOP	11
Overall Study	NOT COMPLETED	Zolinza + CHOP	3

Source ClinicalTrials.gov

Adverse events74

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Schedule A: Vorinostat Once or Twice Daily	6	8	6
other	Fatigue	General disorders	Schedule B: Vorinostat Three Times Daily	5	6	5
other	Oral Mucositis	General disorders	Schedule A: Vorinostat Once or Twice Daily	2	8	2
other	Oral Mucositis	General disorders	Schedule B: Vorinostat Three Times Daily	0	6	0
other	Insomnia	General disorders	Schedule A: Vorinostat Once or Twice Daily	1	8	1
other	Insomnia	General disorders	Schedule B: Vorinostat Three Times Daily	0	6	0
other	Dizziness	General disorders	Schedule A: Vorinostat Once or Twice Daily	4	8	4
other	Dizziness	General disorders	Schedule B: Vorinostat Three Times Daily	0	6	0
other	Anorexia	General disorders	Schedule A: Vorinostat Once or Twice Daily	0	8
other	Anorexia	General disorders	Schedule B: Vorinostat Three Times Daily	2	6	2

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Schedule A: Vorinostat Once or Twice Daily
Total, all-cause mortality	Schedule B: Vorinostat Three Times Daily
Total, other adverse events	Schedule A: Vorinostat Once or Twice Daily	8	8
Total, other adverse events	Schedule B: Vorinostat Three Times Daily	6	6
Total, serious adverse events	Schedule A: Vorinostat Once or Twice Daily	8	8
Total, serious adverse events	Schedule B: Vorinostat Three Times Daily	5	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Schedule A - Vorinostat Once Daily vs Schedule A - Vorinostat Twice Daily: Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat	Trial comparisons
Schedule A: Vorinostat Once or Twice Daily vs Schedule B: Vorinostat Three Times Daily: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00787527

GET https://conductscience.org/api/trials/v1/NCT00787527/events?page=2

API reference For AI assistants