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Promising combo targets rare leukemia

NCT ID NCT00412594

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a two-step treatment for hairy cell leukemia, a rare blood cancer. First, patients receive chemotherapy (cladribine) to kill cancer cells, then an immunotherapy drug (rituximab) to help the immune system attack any remaining cells. The goal is to see if adding rituximab leads to more complete remissions and longer disease control. The trial is for adults with newly diagnosed or relapsed disease who have had no more than one prior treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2004

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years and older * Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination * Patients with relapsed disease are eligible if they have had no more than one prior therapy * Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study * Performance status =\< 3 * Creatinine less than or equal to 2.0 unless related to the disease * Bilirubin less than or equal to 3.0 * Transaminases less than or equal 3 x upper limit of normal unless related to the disease * No prior investigational agent in the 4 weeks prior to initiation of therapy Exclusion Criteria: * Unable or unwilling to sign the consent form * Known infection with human immunodeficiency virus (HIV), hepatitis B or C * Presence of active infection * Presence of central nervous system (CNS) metastases * New York Heart Association classification III or IV heart disease * Prior chemotherapy (last 4 weeks)

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Conditions

The condition(s) this trial relates to.

hairy cell leukemia refractory hairy cell leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hairy cell leukemia Recurrent hairy cell leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.