Participant flow

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.

groups

1. 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

   FG000

   title

   Non-Randomized to 70 mg/m2 Bendamustine-Rituximab

2. 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

   FG001

   title

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

3. 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

   FG002

   title

   Randomized to 90 mg/m^2 Bendamustine-Rituximab

4. 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

   FG003

   title

   Randomized to Pentostatin-Rituximab

5. 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

   FG004

   title

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

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Did not receive 6 cycles.

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         28

      4. group Id

         FG003

         num Subjects

         28

      5. group Id

         FG004

         num Subjects

         1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         24

      4. group Id

         FG003

         num Subjects

         27

      5. group Id

         FG004

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice