Can a second drug wipe out hidden leukemia cells?
NCT ID NCT00923013
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial tests whether adding rituximab to the standard drug cladribine can eliminate leftover cancer cells in people with hairy cell leukemia, a rare blood cancer. Half the participants receive both drugs at the start, while the other half get rituximab later only if needed. The goal is to see which approach better clears minimal residual disease—the small number of cancer cells that can remain after treatment and raise the risk of relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cladribine and rituximab
- What this could lead to
- If successful, this combination could reduce the chance of relapse and move closer to a lasting remission for hairy cell leukemia.
- What could go wrong
- This is an early-phase trial, so results may not confirm benefit. Adding rituximab could increase side effects, and the study may not lead to a cure.
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
-
175 people
The number who actually took part.
- Started
-
Oct 2008
- Expected to finish
-
Jan 2030
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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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 Hide 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: Evidence of Hairy Cell Leukemia (HCL) by flow cytometry, reviewed by the Laboratory of Pathology, National Cancer Institute (NCI), including positivity for Cluster of Differentiation 19 (CD19), Cluster of Differentiation 22 (CD22), cluster of differentiation 20 (CD20), and integrin alpha X (CD11c). Bone marrow biopsy (BMBx) consistent with HCL, reviewed by Laboratory of Pathology, NCI. BMBx may be negative in hairy cell leukemia variant, (HCLv) in patients with increasing peripheral blood HCLv cells and spleen size. Treatment indicated based on demonstration of at least one of the following, no more than 4 weeks from the time of enrollment, and no less than 6 months after prior purine analog and no less than 4 weeks after other prior treatment, if applicable. * Neutropenia (absolute neutrophil count (ANC) less than 1000 cells/microl). * Anemia (hemoglobin (Hgb) less than 10g/dL). * Thrombocytopenia (Platelet (Plt) less than 100,000/microl). * Absolute lymphocyte count (ALC) of greater than 5,000 cells/microL * Symptomatic splenomegaly. * Enlarging lymph nodes greater than 2cm. * Repeated infections requiring oral or intravenous (i.v.) antibiotics. * Patients who have eligible blood counts within 4 weeks from enrollment will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment. No prior purine analog therapy except up to 1 prior course of cladribine. No prior rituximab unless HCLv patient. Eastern Cooperative Oncology Group (ECOG) performance status (78) of 0-3. Patients must be able to understand and give informed consent. Women of child-bearing age and all men must use birth control of any type until at least 12 months after the last dose of therapy. Creatinine less than or equal to 1.5 or creatinine clearance greater than or equal to 60 ml/ml. Bilirubin less than or equal to 2 unless consistent with Gilbert's (total/direct greater than 5), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limits of normal. No other therapy (i.e. chemotherapy, interferon) for 4 weeks prior to study entry, or cladribine for 6 months prior to study entry. Age at least 18 Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment. Subject has provided written informed consent Patients must be willing to co-enroll in the investigators companion protocol 10-C-0066 titled Collection of Human Samples to Study Hairy Cell and other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment. EXCLUSION CRITERIA: Presence of active untreated infection Uncontrolled coronary disease or New York Heart Association Classification (NYHA) class III-IV heart disease. Known infection with HIV. Hepatitis B is allowed only if viral load is undetectable and if on anti-hepatitis B therapy like Entecavir. Hepatitis C is allowed only if viral load is undetectable, and if the patient has received curative therapy. Patients with documented history of no response to cladribine, and without 50% improvement in platelets, hemoglobin or granulocytes. This exclusion does not apply to HCLv. These patients are eligible regardless of prior response to chlorodeoxyadenosine (CDA) Pregnant or lactating women. Presence of active 2nd malignancy requiring treatment. 2nd malignancies with low activity which do not require treatment (i.e. low-grade prostate cancer, basal cell or squamous cell skin cancer) do not constitute exclusions. Inability to comply with study and/or follow-up procedures. Presence of central nervous system (CNS) disease, which is symptomatic. At the Investigators discretion, receipt of a live vaccine within 4 weeks prior to randomization. Efficacy and/or safety of immunization during periods of B-cell depletion have not been adequately studied. It is recommended that a patients vaccination record and possible requirements be reviewed. Per the investigator's discretion, the patient may have any required vaccination/booster administered at least 4 weeks prior to the initiation of study treatment. Review of the patient s immunization status for the following vaccinations is recommended: tetanus; diphtheria; influenza; pneumococcal polysaccharide; Varicella; measles, mumps and rubella (MMR); and hepatitis B. Patients who are considered to be at high risk for hepatitis B virus (HBV) infection and for whom the investigator has determined that immunization is indicated should complete the entire HBV vaccine series at least 4 weeks prior to participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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