Hairy cell leukemia

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12 regimens on this page 17 variants on this page

Untreated

Cladribine (Leustatin)

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Regimen #1

Study	Evidence
Tallman et al. 1996	Phase II

• Cladribine (Leustatin) 0.1 mg/kg/day IV continuous infusion on days 1 to 7 (total dose per cycle: 0.7 mg/kg)

7-day course

Regimen #2

Study	Evidence	Comparator
Zenhäusern et al. 2009 (SAKK 32/98)	Phase III	Weekly Cladribine

• Cladribine (Leustatin) 0.14 mg/kg/day IV continuous infusion on days 1 to 5 (total dose per cycle: 0.7 mg/kg)

5-day course

Regimen #3

Study	Evidence	Comparator
Zenhäusern et al. 2009 (SAKK 32/98)	Phase III	Daily Cladribine

• Cladribine (Leustatin) 0.14 mg/kg/day IV once per day on days 1, 8, 15, 22, 29

5-week course

Regimen #4

Study	Evidence
Damasio et al. 1998	Phase II

Cladribine (Leustatin) 0.15 mg/kg IV over 2 hours once per day for 5 consecutive days

One course

Regimen #5

Study	Evidence
Robak et al. 1999	Phase II

Cladribine (Leustatin) 0.12 mg/kg IV over 2 hours once per day for 5 consecutive days

One course

References

1. Tallman MS, Hakimian D, Rademaker AW, Zanzig C, Wollins E, Rose E, Peterson LC. Relapse of hairy cell leukemia after 2-chlorodeoxyadenosine: long-term follow-up of the Northwestern University experience. Blood. 1996 Sep 15;88(6):1954-9. link to original article contains verified protocol PubMed
   1. Update: Chadha P, Rademaker AW, Mendiratta P, Kim B, Evanchuk DM, Hakimian D, Peterson LC, Tallman MS. Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine (2-CdA): long-term follow-up of the Northwestern University experience. Blood. 2005 Jul 1;106(1):241-6. Epub 2005 Mar 10. link to original article contains protocol PubMed content property of HemOnc.org
2. Damasio EE, Resegotti L, Masoudi B, Bruni R, Cerri R, Isaza A, Clavio M, Risso M, Rossi E, Spriano M, Truini M. Five day intermittent vs seven day continuous 2-chlorodeoxyadenosine infusion for the treatment of hairy cell leukemia. A study by Italian Group for the Hairy Cell Leukemia. Recenti Prog Med. 1998 Feb;89(2):68-73. PubMed
3. Robak T, Błasińska-Morawiec M, Błoński J, Hellmann A, Hałaburda K, Konopka L, Kotlarek-Haus S, Potoczek S, Hansz J, Dmoszyńska A, Urasiński I, Zdziarska B, Dwilewicz-Trojaczek J, Hołowiecki J, Skotnicki AB. 2-chlorodeoxyadenosine (cladribine) in the treatment of hairy cell leukemia and hairy cell leukemia variant: 7-year experience in Poland. Eur J Haematol. 1999 Jan;62(1):49-56. PubMed
4. Zenhäusern R, Schmitz SF, Solenthaler M, Heim D, Meyer-Monard S, Hess U, Leoncini L, Bargetzi M, Rufener B, Tobler A. Randomized trial of daily versus weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98). Leuk Lymphoma. 2009 Sep;50(9):1501-11. link to original article contains protocol PubMed

Cladribine & Rituximab

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Regimen

Study	Evidence
Ravandi et al. 2011	Phase II

• Cladribine (Leustatin) 5.6 mg/m2 IV over 2 hours once per day on days 1 to 5

Supportive medications: All were administered at the discretion of the treating physician.

• Levofloxacin (Levaquin)
• Valacyclovir (Valtrex)
• Fluconazole (Diflucan)
• Filgrastim (Neupogen)

28 days after administration of cladribine, bone marrow examination was repeated, and then rituximab was started:

• Rituximab (Rituxan) 375 mg/m2 IV once per week for 8 weeks

One course

References

1. Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood. 2011 Oct 6;118(14):3818-23. link to original article contains verified protocol PubMed

Pentostatin (Nipent)

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Regimen #1

Study	Evidence
Cassileth et al. 1991	Phase II

• Pentostatin (Nipent) 5 mg/m2 IV over 2 minutes once per day on days 1 & 2

14-day cycles, continued to the point of maximal response or treatment failure

Regimen #2

Study	Evidence	Comparator
Grever et al. 1995	Phase III	Interferon alfa-2a

• Pentostatin (Nipent) 4 mg/m2 IV rapid injection once on day 1
  • Grever et al. 1995: Patients with performance status of 3 received an initial dose of Pentostatin (Nipent) 2 mg/m2 IV rapid injection once on day 1, which would be increased in later cycles to Pentostatin (Nipent) 4 mg/m2 IV rapid injection once on day 1 if patients had no adverse reactions.
  • Grever et al. 1995: Doses of pentostatin were held for patients who had an increase in the serum creatinine concentration >20% above their baseline. Pentostatin was not given until renal function returned to baseline or if 24-hour creatinine clearance was >50 mL/min.

Supportive medications (per Grever et al. 1995):

• 1.5 liters of IV fluid hydration with every dose of pentostatin

14 day cycles; patients who had complete response before 6 months were given 2 additional cycles of pentostatin, and then treatment was stopped. Patients with objective partial response after 6 months of treatment received an additional 6 months of additional therapy, until they had a complete response or progression of disease.

References

1. Cassileth PA, Cheuvart B, Spiers AS, Harrington DP, Cummings FJ, Neiman RS, Bennett JM, O'Connell MJ. Pentostatin induces durable remissions in hairy cell leukemia. J Clin Oncol. 1991 Feb;9(2):243-6. link to original article contains protocol PubMed
2. Grever M, Kopecky K, Foucar MK, Head D, Bennett JM, Hutchison RE, Corbett WE, Cassileth PA, Habermann T, Golomb H, et al. Randomized comparison of pentostatin versus interferon alfa-2a in previously untreated patients with hairy cell leukemia: an intergroup study. J Clin Oncol. 1995 Apr;13(4):974-82. link to original article contains verified protocol PubMed
   1. Update: Flinn IW, Kopecky KJ, Foucar MK, Head D, Bennett JM, Hutchison R, Corbett W, Cassileth P, Habermann T, Golomb H, Rai K, Eisenhauer E, Appelbaum F, Cheson B, Grever MR. Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin. Blood. 2000 Nov 1;96(9):2981-6. link to original article contains verified protocol PubMed

Relapsed/Refractory

BR

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BR: Bendamustine, Rituximab

Regimen

Study	Evidence
Burotto et al. 2013	Pilot, <20 patients

• Rituximab (Rituxan) 375 mg/m2 IV once per day on days 1 & 15
• Bendamustine (Treanda) 70 or 90 mg/m2 IV once per day on days 1 & 2

28-day cycle x 6 cycles

References

1. Burotto M, Stetler-Stevenson M, Arons E, Zhou H, Wilson W, Kreitman RJ. Bendamustine and Rituximab in Relapsed and Refractory Hairy Cell Leukemia. Clin Cancer Res. 2013 Oct 28. [Epub ahead of print] link to original article PubMed

Rituximab (Rituxan)

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Regimen

Study	Evidence
Nieva et al. Blood 2003	Phase II

• Rituximab (Rituxan) 375 mg/m2 IV once per week for 4 consecutive weeks
  • Initial infusions were given at 50 mg per hour for the first 30 minutes, and if no toxicity was observed, the infusion rate was escalated at 30-minute intervals to a peak infusion rate of 300 mg per hour.

Supportive medications:

• Allopurinol (Zyloprim) 300 mg PO once per day for the first 7 days of treatment

One 4-week course

References

1. Nieva J, Bethel K, Saven A. Phase 2 study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia. Blood. 2003 Aug 1;102(3):810-3. link to original article contains verified protocol PubMed