NCT00601718 · OUTCOME

Safety and Toxicity According to CTCAE v3.0

Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma · Source last updated 2017-05-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 3-5 weeks post end of treatment

What was measured

Common dose limiting toxicities.

Groups in this outcome

Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO rituximab: Given IV ifosfamide: Given IV carboplatin: Given IV etoposide: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies gene expression analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy	29

Reported measurements

Infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy	2	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy	2	Not reported	Not reported	Not reported	Not reported

Transaminitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy	2	Not reported	Not reported	Not reported	Not reported

Grade 3 related gastrointestinal toxicity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy	9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
title
Infection
categories
measurements
group Id
OG000
value
2
title
Hypokalemia
categories
measurements
group Id
OG000
value
2
title
Transaminitis
categories
measurements
group Id
OG000
value
9
title
Grade 3 related gastrointestinal toxicity

denoms

counts
group Id
OG000
value
29
units
Participants

description

Common dose limiting toxicities.

groups

description
Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO rituximab: Given IV ifosfamide: Given IV carboplatin: Given IV etoposide: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies gene expression analysis: Correlative studies
id
OG000
title
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

3-5 weeks post end of treatment

title

Safety and Toxicity According to CTCAE v3.0

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice