NCT01419795 · OUTCOME

Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD

Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant · Source last updated 2017-07-27

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: Assessed up to 30 days after completion of study treatment

Analysis population: No participants enrolled in the second arm.

Groups in this outcome

Arm I (Lenalidomide, Rituximab)

Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies

Arm II (Lenalidomide)

Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker 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
Arm I (Lenalidomide, Rituximab)	3
Arm II (Lenalidomide)	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Lenalidomide, Rituximab)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
0
units
Participants

groups

description
Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11. lenalidomide: Given PO rituximab: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
id
OG000
title
Arm I (Lenalidomide, Rituximab)
description
Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I. lenalidomide: Given PO pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
id
OG001
title
Arm II (Lenalidomide)

param Type

COUNT_OF_PARTICIPANTS

population Description

No participants enrolled in the second arm.

reporting Status

POSTED

time Frame

Assessed up to 30 days after completion of study treatment

title

Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice