NCT01059786 · OUTCOME

Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR)

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2026-07-22

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: At end of treatment, approximately 6 months

What was measured

Number of participants receiving pentostatin + rituximab and bendamustine + rituximab who achieve a CR +PR measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\^3, platelets ≥ 100,000/mm\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters or decrease to ≤ 2 cm in evaluable (\> 2cm) lymphadenopathy.

Groups in this outcome

Non-Randomized to 70 mg/m2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

Non-randomized to 90 mg/m^2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated

Randomized to 90 mg/m^2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

Randomized to Pentostatin-Rituximab

Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated

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
Non-Randomized to 70 mg/m2 Bendamustine-Rituximab	6
Non-randomized to 90 mg/m^2 Bendamustine-Rituximab	6
Randomized to 90 mg/m^2 Bendamustine-Rituximab	28
Randomized to Pentostatin-Rituximab	28
Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab	1

Reported measurements

Complete Remission

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Non-Randomized to 70 mg/m2 Bendamustine-Rituximab	3	Not reported	Not reported	Not reported	Not reported
Non-randomized to 90 mg/m^2 Bendamustine-Rituximab	4	Not reported	Not reported	Not reported	Not reported
Randomized to 90 mg/m^2 Bendamustine-Rituximab	20	Not reported	Not reported	Not reported	Not reported
Randomized to Pentostatin-Rituximab	22	Not reported	Not reported	Not reported	Not reported
Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab	1	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Non-Randomized to 70 mg/m2 Bendamustine-Rituximab	3	Not reported	Not reported	Not reported	Not reported
Non-randomized to 90 mg/m^2 Bendamustine-Rituximab	2	Not reported	Not reported	Not reported	Not reported
Randomized to 90 mg/m^2 Bendamustine-Rituximab	4	Not reported	Not reported	Not reported	Not reported
Randomized to Pentostatin-Rituximab	4	Not reported	Not reported	Not reported	Not reported
Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
20
group Id
OG003
value
22
group Id
OG004
value
1
title
Complete Remission
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
4
group Id
OG003
value
4
group Id
OG004
value
0
title
Partial Response

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
28
group Id
OG003
value
28
group Id
OG004
value
1
units
Participants

description

groups

description
Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
id
OG000
title
Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
description
Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated
id
OG001
title
Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
description
Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
id
OG002
title
Randomized to 90 mg/m^2 Bendamustine-Rituximab
description
Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
id
OG003
title
Randomized to Pentostatin-Rituximab
description
Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated
id
OG004
title
Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

At end of treatment, approximately 6 months

title

Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice