Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Cladribine (2-chlorodeoxyadenosine, 2-CdA) and pentostatin are both highly efficacious in the treatment of patients with disease refractory to interferon-alpha.[1,2] Rituximab can induce durable complete remissions with minimal toxic effects in the majority of patients with relapsing or refractory disease after purine analog therapy.[3-5][Level of evidence: 3iiiDiv] The lack of subsequent immunosuppression with rituximab has made this treatment the first choice among relapsing patients in the absence of a clinical trial.[5] Patients who relapse after cladribine or pentostatin often respond to retreatment with the same or another purine analog.[6-10] An anti-CD22 recombinant immunotoxin under clinical evaluation can induce complete remissions in patients resistant to retreatment with purine analogs.[11][Level of evidence: 3iiiDiv]

Allogeneic bone marrow transplantation may be considered for selected patients in rare instances. The patients should be in good health and have an HLA-identical sibling. The high mortality of this procedure justifies its use only in refractory cases.[12]

Aggressive, high-dose chemotherapy has been beneficial in some cases, but the associated morbidity and mortality are high. It should not be considered unless other, more frequently effective therapies have been exhausted.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with refractory hairy cell leukemia. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Piro LD, Carrera CJ, Carson DA, et al.: Lasting remissions in hairy-cell leukemia induced by a single infusion of 2-chlorodeoxyadenosine. N Engl J Med 322 (16): 1117-21, 1990.  [PUBMED Abstract]
   
   
2. Tallman MS, Hakimian D, Variakojis D, et al.: A single cycle of 2-chlorodeoxyadenosine results in complete remission in the majority of patients with hairy cell leukemia. Blood 80 (9): 2203-9, 1992.  [PUBMED Abstract]
   
   
3. Hagberg H, Lundholm L: Rituximab, a chimaeric anti-CD20 monoclonal antibody, in the treatment of hairy cell leukaemia. Br J Haematol 115 (3): 609-11, 2001.  [PUBMED Abstract]
   
   
4. Lauria F, Lenoci M, Annino L, et al.: Efficacy of anti-CD20 monoclonal antibodies (Mabthera) in patients with progressed hairy cell leukemia. Haematologica 86 (10): 1046-50, 2001.  [PUBMED Abstract]
   
   
5. Thomas DA, O'Brien S, Bueso-Ramos C, et al.: Rituximab in relapsed or refractory hairy cell leukemia. Blood 102 (12): 3906-11, 2003.  [PUBMED Abstract]
   
   
6. Hoffman MA, Janson D, Rose E, et al.: Treatment of hairy-cell leukemia with cladribine: response, toxicity, and long-term follow-up. J Clin Oncol 15 (3): 1138-42, 1997.  [PUBMED Abstract]
   
   
7. Goodman GR, Burian C, Koziol JA, et al.: Extended follow-up of patients with hairy cell leukemia after treatment with cladribine. J Clin Oncol 21 (5): 891-6, 2003.  [PUBMED Abstract]
   
   
8. Ribeiro P, Bouaffia F, Peaud PY, et al.: Long term outcome of patients with hairy cell leukemia treated with pentostatin. Cancer 85 (1): 65-71, 1999.  [PUBMED Abstract]
   
   
9. Zinzani PL, Magagnoli M, Bendandi M, et al.: Long-term follow-up of hairy cell leukemia patients treated with 2-chlorodeoxyadenosine. Haematologica 85 (9): 922-5, 2000.  [PUBMED Abstract]
   
   
10. Gidron A, Tallman MS: 2-CdA in the treatment of hairy cell leukemia: a review of long-term follow-up. Leuk Lymphoma 47 (11): 2301-7, 2006.  [PUBMED Abstract]
    
    
11. Kreitman RJ, Wilson WH, Bergeron K, et al.: Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N Engl J Med 345 (4): 241-7, 2001.  [PUBMED Abstract]
    
    
12. Cheever MA, Fefer A, Greenberg PD, et al.: Treatment of hairy-cell leukemia with chemoradiotherapy and identical-twin bone-marrow transplantation. N Engl J Med 307 (8): 479-81, 1982.  [PUBMED Abstract]
    
    

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