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NCT00923013 · OUTCOME

Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups

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.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Restaged 6 months after the start of treatment

What was measured

Participants with newly diagnosed Hairy Cell Leukemia (HCL) and once relapsed HCL were split and both groups were randomized to receive either simultaneous treatment with Cladribine and Rituxan or Cladribine with Rituxan given no earlier than 6 months after cladribine as needed. Outcome measured by Bone Marrow and Blood Flow cytometry and histochemistry of the core biopsy at the 6 months after start of treatment time point. If all three were negative for hairy cells participants were in a minimal residual disease status (MRD). And were considered without HCL disease at that time point.

Analysis population: Cohort 2, Arm 3 and Cohort 3, Arm 3 are not reported because the investigator is only comparing the randomized groups. The primary goal is comparing the randomization and Cohort 2 was not randomized.

Groups in this outcome

Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab

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.

Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab

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.

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

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).

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

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).

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

Analysis denominator · Participants

GroupSource count
Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab34
Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab32
Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)34
Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)30

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab97.1Not reportedNot reportedNot reportedNot reported
Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab62.5Not reportedNot reportedNot reportedNot reported
Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)23.5Not reportedNot reportedNot reportedNot reported
Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)3.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        97.1
      2. group Id
        OG001
        value
        62.5
      3. group Id
        OG002
        value
        23.5
      4. group Id
        OG003
        value
        3.3
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      34
    4. group Id
      OG003
      value
      30
    units
    Participants
description
Participants with newly diagnosed Hairy Cell Leukemia (HCL) and once relapsed HCL were split and both groups were randomized to receive either simultaneous treatment with Cladribine and Rituxan or Cladribine with Rituxan given no earlier than 6 months after cladribine as needed. Outcome measured by Bone Marrow and Blood Flow cytometry and histochemistry of the core biopsy at the 6 months after start of treatment time point. If all three were negative for hairy cells participants were in a minimal residual disease status (MRD). And were considered without HCL disease at that time point.
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
param Type
NUMBER
population Description
Cohort 2, Arm 3 and Cohort 3, Arm 3 are not reported because the investigator is only comparing the randomized groups. The primary goal is comparing the randomization and Cohort 2 was not randomized.
reporting Status
POSTED
time Frame
Restaged 6 months after the start of treatment
title
Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice