Hairy cell leukemia

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Untreated

Cladribine (Leustatin)

Regimen #1, 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, Zenhäusern et al. 2009 (SAKK 32/98)

Phase III

• 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, Zenhäusern et al. 2009 (SAKK 32/98)

Phase III

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

5-week course

Regimen #4, Damasio et al. 1998

Phase II

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

One course

Regimen #5, Robak et al. 1999

Phase II

Cladribine (Leustatin) 0.12 mg/kg IV over 2 hours once daily 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
2. 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
3. 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
4. Damasio EE, Resegotti L, Masoudi B, et al: 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 89:68-73, 1998
5. Robak T, Blasinska-Moraweic M, Blonski J, et al: 2′chlorodeoxyadenosine (caldribine) in the treatment of hairy cell leukemia and hairy cell leukemia variant: 7 year experience-Poland. Eur J Haematol 62:49-56, 1999

Cladribine & Rituximab

Regimen, Ravandi et al. 2011

Phase II

• Cladribine (Leustatin) 5.6 mg/m2 IV 2 hours daily for 5 days

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

• Levofloxacin (Levaquin)
• Valcyclovir (Valcyte)
• 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 weekly 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)

Regimen #1, 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, Grever et al. 1995 & Flinn et al. 2000

Phase III

• 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
3. 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

BR: Bendamustine, Rituximab

Regimen, Burotto et al. 2013

Pilot, <20 patients reported

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

28-day cycles 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)

Regimen, Nieva et al. Blood 2003

Phase II

• Rituximab (Rituxan) 375 mg/m2 IV weekly 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