Relapsed hairy cell leukemia 35
Table I. HCL-specific open clinical trials.
Agents Phase Line Center Cancer.gov NCT# Reference
Cladribineþrituximab Phase II non-randomized 1st/2nd MDA NCT00412594 [44]
Cladribineþrituximab Phase II randomized 1st/2nd NCI NCT00781235
LMB-2 Phase II 42nd NCI NCT00337311 [28,29]
BL22 Phase II retreatment 43rd NCI NCT00850525 [34–36]
HA22 (CAT-8015) Phase I 42nd NCI, NW NCT00462189 ASH, 2008, #3160
Stanford
Lodz
HCL, hairy cell leukemia.
For the two cladribineþrituximab trials, patients begin treatment at MD Anderson (Houston, TX) or at the National Cancer Institute, NIH
(Bethesda, MD), respectively, and subsequent treatment may be given by local physicians.
HA22, also called CAT-8015, is administered at NCI, Northwestern (Chicago, IL), Stanford University (Stanford, CA) or at the University
of Lodz (Lodz, Poland).
determine if rituximab can decrease the rate of MRD
3. Jehn U, Bartl R, Dietzfelbinger H, et al. An update: 12-year
observed in the blood at 6 months, the time point at
follow-up of patients with hairy cell leukemia following
treatment with 2-chlorodeoxyadenosine. Leukemia 2004;18:
which patients generally achieve their minimum
1476–1481.
disease burden after cladribine [65,66]. The 2nd
4. Saven A, Burian C, Koziol JA, et al. Long-term follow-up of
goal is to determine if MRD-free survival is better if patients with hairy cell leukemia after cladribine treatment.
rituximab is used up front or delayed. It is quite
Blood 1998;92:1918–1926.
possible that rituximab may work better if delayed at
5. Else M, Dearden CE, Matutes E, et al. Long-term follow-up
of 233 patients with hairy cell leukaemia, treated initially with
least 6 months after cladribine when disease is
pentostatin or cladribine, at a median of 16 years from
minimal and clumps of cells are more permeable
diagnosis. Br J Haematol. Epub ahead of print.
to rituximab. Alternatively, rituximab may work 6. Seymour JF, Kurzrock R, Freireich EJ, et al. 2-chlorodeox-
synergistically with cladribine and have optimal
yadenosine induces durable remissions and prolonged sup-
activity up front. Regardless of when the rituximab
pression of CD4þlymphocyte counts in patients with hairy
cell leukemia. Blood 1994;83:2906–2911.
is added in combination with cladribine, we believe
7. Seymour JF, Talpaz M, Kurzrock R. Response duration and
that patients with early HCL may benefit from
recovery of CD4þlymphocytes following deoxycoformycin in
combined treatment and should be referred for interferon-alpha-resistant hairy cell leukemia: 7-year follow-
the randomized and non-randomized trials of
up. Leukemia 1997;11:42–47.
cladribine and rituximab if possible. Because of the
8. Hagberg H, Lundholm L. Rituximab, a chimaeric anti-CD20
monoclonal antibody, in the treatment of hairy cell leukaemia.
cumulative and long term toxicity or purine analogs
Br J Haematol 2001;115:609–611.
and the lack of long-term toxicity with recombinant
9. Lauria F, Lenoci M, Annino L, et al. Efficacy of anti-
immunotoxins, we believe that patients with multiply CD20 monoclonal antibodies (Mabthera) in patients with
relapsed HCL should avoid repeated courses of
progressed hairy cell leukemia. Haematologica 2001;86:1046–
purine analog and if possible enroll in a clinical
1050.
10. Nieva J, Bethel K, Saven A. Phase 2 study of rituximab in the
trial testing recombinant immunotoxin HA22
treatment of cladribine-failed patients with hairy cell leukemia.
(CAT-8015).
Blood 2003;102:810–813.
11. Thomas DA, O’Brien S, Bueso-Ramos C, et al. Rituximab in
relapsed or refractory hairy cell leukemia. Blood 2003;102:
Acknowledgment
3906–3911.
12. Angelopoulou MK, Pangalis GA, Sachanas S, et al. Outcome
This work is supported in part by the Intramural
and toxicity in relapsed hairy cell leukemia patients treated
Research Program of the NCI, NIH, and work on
with rituximab. Leuk Lymphoma 2008;49:1817–1820.
BL22 and HA22 is supported in part by MedIm- 13. Zenhausern R, Simcock M, Gratwohl A, et al. Rituximab in
mune, LLC.
patients with hairy cell leukemia relapsing after treatment with
2-chlorodeoxyadenosine (SAKK 31/98). Haematol Hematol J
2008;93:1426–1428.
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