Participant flow

Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia · Source last updated 2026-08-18

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

groups

1. description

   Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.

   id

   FG000

   title

   Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab

2. description

   Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.

   id

   FG001

   title

   Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab

3. description

   Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).

   id

   FG002

   title

   Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)

4. description

   Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).

   id

   FG003

   title

   Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)

5. description

   Participants with Hairy Cell Leukemia (HCL) without prior course of purine analog to be directly assigned to Arm 3 (25 participants; after completion of the 68 participants without prior purine analog in Cohort 1). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine

   id

   FG004

   title

   Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)

6. description

   Participants with Hairy Cell Leukemia Variant (HCLv) to be directly assigned to Arm 3 (20 participants). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine

   id

   FG005

   title

   Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Refused further treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Switched to alternative treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Death on study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         32

      3. group Id

         FG002

         num Subjects

         34

      4. group Id

         FG003

         num Subjects

         30

      5. group Id

         FG004

         num Subjects

         25

      6. group Id

         FG005

         num Subjects

         20

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         4

      type

      Disease progression on study

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Refused further follow-up

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Death during follow-up period

   5. achievements

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         28

      3. group Id

         FG002

         num Subjects

         32

      4. group Id

         FG003

         num Subjects

         29

      5. group Id

         FG004

         num Subjects

         25

      6. group Id

         FG005

         num Subjects

         20

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice