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NCT00412594

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Recruiting now Phase 2 Last updated 22 December 2025
What this trial tests

Phase 2 trial testing Cladribine in Hairy Cell Leukemia in 150 participants. Currently enrolling.

Timeline
10 June 2004
Primary endpoint
30 June 2027
30 June 2027

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment150
Start date10 June 2004
Primary completion30 June 2027
Estimated completion30 June 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Hairy Cell Leukemia or Recurrent Hairy Cell Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia.
    Ravandi F, O'Brien S, Jorgensen J, Pierce S, et al · · 2011 · cited 73× · PMID 21821712 · DOI 10.1182/blood-2011-04-351502
  2. Approach to the patient after relapse of hairy cell leukemia.
    Kreitman RJ, Fitzgerald DJ, Pastan I. · · 2009 · cited 8× · PMID 19814696 · DOI 10.3109/10428190903142216
  3. Long-term results of the sequential combination of cladribine and rituximab in Hairy cell leukemia.
    Marvin-Peek J, Jen WY, Kantarjian HM, McCue D, et al · · 2024 · cited 6× · PMID 38749022 · DOI 10.1080/10428194.2024.2349700
  4. Current and emerging treatment options for hairy cell leukemia.
    López-Rubio M, Garcia-Marco JA. · · 2015 · cited 4× · PMID 26316784 · DOI 10.2147/ott.s70316
  5. The protective role of the microenvironment in hairy cell leukemia treatment: Facts and perspectives.
    Gargiulo E, Giordano M, Niemann CU, Moussay E, et al · · 2023 · cited 2× · PMID 36968995 · DOI 10.3389/fonc.2023.1122699
  6. Hairy cell leukemia - immunotargets and therapies.
    Basheer F, Bloxham DM, Scott MA, Follows GA. · · 2014 · cited 2× · PMID 27471703 · DOI 10.2147/itt.s31425

Verify or expand the search:

Other trials of Cladribine

Trials testing the same drug.

Other recruiting trials for Hairy Cell Leukemia

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00412594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing