Treatment of hairy-cell leukemia with cladribine: response, toxicity, and long-term follow-up.

1997 ◽  
Vol 15 (3) ◽  
pp. 1138-1142 ◽  
Author(s):  
M A Hoffman ◽  
D Janson ◽  
E Rose ◽  
K R Rai
Keyword(s):  
Hairy Cell Leukemia ◽  
Opportunistic Infections ◽  
Medical Center ◽  
Second Malignancies ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Island Jewish Medical ◽  
Negative Phenotype

PURPOSE To analyze initial and long-term outcomes after treatment of patients with active hairy-cell leukemia (HCL) with a single cycle of cladribine (2-CdA). PATIENTS AND METHODS Forty-nine patients with active HCL were treated with 2-CdA by continuous intravenous infusion at 0.1 mg/kg/d for a total of 7 days at the Long Island Jewish Medical Center between September 1990 and August 1992. Here we report on all patients followed-up until April 1996. RESULTS At 3 months after treatment, complete response (CR) occurred in 37 patients (76%) and partial response (PR) occurred in 12 patients (24%), for an overall response rate of 100% (95% confidence interval, 94% to 100%). At a median follow-up of 55 months, the relapse-free survival is 80% and overall survival is 95%. Ten patients (20%) have relapsed. Of the 26 patients in whom lymphocyte phenotyping was performed, four were found to have a CD25-negative phenotype. All four of these patients had PRs only and all relapsed. Eight patients have been re-treated with 2-CdA, and all achieved at least a partial remission; two of these have already relapsed with remission durations of less than 1 year. Five second malignancies have occurred in four patients. CONCLUSION With a median follow-up of more than 4 years, 39 patients (80%) continue in remission. Only two deaths have occurred. A CD25-negative phenotype may predict for a poorer response to 2-CdA. Patients who relapse may be re-treated with 2-CdA, but subsequent remissions may be of shorter duration. There has not been a markedly increased incidence of second malignancies or late opportunistic infections.

scholarly journals Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Robert J. Kreitman ◽  
◽  
Claire Dearden ◽  
Pier Luigi Zinzani ◽  
Julio Delgado ◽  
...  
Keyword(s):  
Hairy Cell Leukemia ◽  
Residual Disease ◽  
Braf Inhibitor ◽  
Nucleoside Analogs ◽  
High Rate ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Long Term Follow Up

Abstract Background Moxetumomab pasudotox is a recombinant CD22-targeting immunotoxin. Here, we present the long-term follow-up analysis of the pivotal, multicenter, open-label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL). Methods Eligible patients had received ≥ 2 prior systemic therapies, including ≥ 2 purine nucleoside analogs (PNAs), or ≥ 1 PNA followed by rituximab or a BRAF inhibitor. Patients received 40 µg/kg moxetumomab pasudotox intravenously on Days 1, 3, and 5 of each 28-day cycle for up to six cycles. Disease response and minimal residual disease (MRD) status were determined by blinded independent central review. The primary endpoint was durable complete response (CR), defined as achieving CR with hematologic remission (HR, blood counts for CR) lasting > 180 days. Results Eighty adult patients were treated with moxetumomab pasudotox and 63% completed six cycles. Patients had received a median of three lines of prior systemic therapy; 49% were PNA-refractory, and 38% were unfit for PNA retreatment. At a median follow-up of 24.6 months, the durable CR rate (CR with HR > 180 days) was 36% (29 patients; 95% confidence interval: 26–48%); CR with HR ≥ 360 days was 33%, and overall CR was 41%. Twenty-seven complete responders (82%) were MRD-negative (34% of all patients). CR lasting ≥ 60 months was 61%, and the median progression-free survival without the loss of HR was 71.7 months. Hemolytic uremic and capillary leak syndromes were each reported in ≤ 10% of patients, and ≤ 5% had grade 3–4 events; these events were generally reversible. No treatment-related deaths were reported. Conclusions Moxetumomab pasudotox resulted in a high rate of durable responses and MRD negativity in heavily pre-treated patients with HCL, with a manageable safety profile. Thus, it represents a new and viable treatment option for patients with R/R HCL, who currently lack adequate therapy. Trial registration ClinicalTrials.gov identifier: NCT01829711; first submitted: April 9, 2013. https://clinicaltrials.gov/ct2/show/NCT01829711

scholarly journals Incidence of response and long-term follow-up in patients with hairy cell leukemia treated with recombinant interferon alfa-2a [see comments]

Blood ◽  
1990 ◽  
Vol 75 (4) ◽  
pp. 839-845 ◽  
Author(s):  
E Berman ◽  
G Heller ◽  
S Kempin ◽  
T Gee ◽  
LL Tran ◽  
...  
Keyword(s):  
Disease Progression ◽  
Hairy Cell Leukemia ◽  
Interferon Alfa ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Minor Response ◽  
Recombinant Interferon ◽  
Long Term Follow Up

Abstract Thirty-five evaluable patients with hairy cell leukemia (HCL) were treated with recombinant interferon alfa-2a (rIFN-alpha 2a), given at a dose of 3 X 10(6) units (U) intramuscularly (IM) daily for 6 months followed by 3 X 10(6) U IM three times a week for an additional 18 months in a single institution study. All treatment was stopped after 24 months. Sixty-nine percent of patients achieved a partial response, 11% a minor response, and 3% (one patient) had stable disease. Six patients (17%) did not respond to rIFN-alpha 2a. Two patients (6%) achieved a response but later progressed on treatment. A total of 23 patients completed 2 years of treatment and are evaluable for long-term follow-up at a median of 20 months postcompletion of therapy (range 9 to 32 months). Eleven patients (48%) have had progression of their disease at a median of 10 months (range .5 to 25 months) after treatment was discontinued. Statistical analysis of pretreatment patient characteristics did not reveal any factor(s) associated with a high probability of responding to rIFN-alpha 2a; however, analysis of post-treatment variables measured after 2 years of treatment suggested that a low platelet count was associated with a high rate of disease progression. These findings are compared with other published trials using rIFN-alpha 2b, a similar but not identical rIFN preparation. We conclude that while rIFN-alpha 2a has a high overall response incidence, the rate of disease progression after therapy is discontinued approaches 50%, and that a subset of patients can be identified who are at high risk for recurrence after completing 2 years of treatment.

Long-Term Follow-Up of Patients With Hairy Cell Leukemia After Cladribine Treatment

Blood ◽  
1998 ◽  
Vol 92 (6) ◽  
pp. 1918-1926 ◽  
Author(s):  
Alan Saven ◽  
Carol Burian ◽  
James A. Koziol ◽  
Lawrence D. Piro
Keyword(s):  
Hairy Cell Leukemia ◽  
Survival Rates ◽  
Complete Response ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Second Neoplasms ◽  
American Society ◽  
La Jolla

Abstract Hairy cell leukemia is a chronic B-cell disorder that follows an indolent, but progressive course. Cladribine (2-chlorodeoxyadenosine) induces complete remissions in the majority of patients after a single course. We report the long-term outcomes, including response rates and their duration; time-to-treatment failure (TTF) rates; retreatment results; toxicities; and survival rates of patients treated at Scripps Clinic (La Jolla, CA). A total of 358 patients with hairy cell leukemia were treated with cladribine at 0.087 or 0.1 mg/kg body weight per day by continuous intravenous infusion for 7 days. The expected number of second neoplasms was based on the National Cancer Institute’s Surveillance Epidemiology and End Results data. Of 349 evaluable patients, 319 (91%) achieved an initial complete response and 22 (7%) a partial response with an overall median duration of response follow-up of 52 months. Ninety patients (26%) had relapsed at a median of 29 months. The TTF rate for all 341 responders was 19% at 48 months, 16% for complete responders, and 54% for partial responders. Of 53 evaluable patients treated with second courses of cladribine at first relapse, 33 (62%) achieved complete responses and 14 (26%) partial responses. Twenty-seven patients (8%) developed second neoplasms (only 1 hematopoietic) with an observed-to-expected ratio of 1.88 (95% confidence interval, 1.24 to 2.74). The overall survival rate was 96% at 48 months. Single courses of cladribine induced long-lasting complete responses in the vast majority of patients. Relapse rates for complete responders were low. Patients who relapse can be successfully retreated with cladribine. Cladribine has high efficacy and a favorable acute and long-term toxicity profile when administered to patients with hairy cell leukemia. © 1998 by The American Society of Hematology.

HSR19-086: Healthcare Costs and Resource Utilization Associated With Adverse Events Among Hairy Cell Leukemia Patients Treated With Purine Nucleoside Analogs

2019 ◽  
Vol 17 (3.5) ◽  
pp. HSR19-086
Author(s):  
Narendranath Epperla ◽  
Melissa Pavilack ◽  
Temitope Olufade ◽  
Richa Bashyal ◽  
Teng Huang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Resource Utilization ◽  
Hairy Cell Leukemia ◽  
Opportunistic Infections ◽  
Nucleoside Analogs ◽  
Purine Nucleoside ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
History Of

Background: Purine nucleoside analogs (PNAs) are highly effective for first-line treatment of hairy cell leukemia (HCL). In clinical trials of single PNAs, several adverse events (AEs) were reported; however, little is known regarding the costs and healthcare resource utilization (HRU) resulting from AEs in HCL patients (pts) treated with PNAs in non-clinical trial settings. Objective: Determine the costs and HRU of high incident and clinically important AEs associated with PNA therapy in HCL pts in the Truven MarketScan database. Methods: Adults (aged ≥18 years) with ≥2 HCL diagnosis codes ≥30 days apart during January 1, 2006–December 31, 2015 were included. Pts had ≥1 prescription claim for a PNA (cladribine or pentostatin ± rituximab) after HCL diagnosis date. First PNA claim date was defined as the index date. Pts had continuous health plan enrollment for ≥6 months at baseline and ≥12-months follow-up with no PNA in the baseline period. Pts were placed into cohorts based on the occurrence of myelosuppression (MSPN) and opportunistic infections (OI) as these were highest incident and clinically important AEs observed. Generalized linear models were used to compare outcomes during the 12-month follow-up. Results: Of the 219 pts with no history of MSPN, 101 developed MSPN (incidence [I]: 461 per 1000 pt-years) and of 619 pts with no history of OI, 26 developed OI (I: 42 per 1000 pt-years). Demographics were similar between pts with and without MSPN and OI. Pts who developed OI or MSPN had significantly higher inpatient admissions and costs (Table 1). Conclusions: PNA-treated HCL pts who developed MSPN or OI incurred higher HRU than those who did not develop either condition. This indicates the need for new therapeutic strategies to reduce HCL-treatment-associated toxicities.

scholarly journals Incidence of response and long-term follow-up in patients with hairy cell leukemia treated with recombinant interferon alfa-2a [see comments]

Blood ◽  
1990 ◽  
Vol 75 (4) ◽  
pp. 839-845
Author(s):  
E Berman ◽  
G Heller ◽  
S Kempin ◽  
T Gee ◽  
LL Tran ◽  
...  
Keyword(s):  
Disease Progression ◽  
Hairy Cell Leukemia ◽  
Interferon Alfa ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Minor Response ◽  
Recombinant Interferon ◽  
Long Term Follow Up

Thirty-five evaluable patients with hairy cell leukemia (HCL) were treated with recombinant interferon alfa-2a (rIFN-alpha 2a), given at a dose of 3 X 10(6) units (U) intramuscularly (IM) daily for 6 months followed by 3 X 10(6) U IM three times a week for an additional 18 months in a single institution study. All treatment was stopped after 24 months. Sixty-nine percent of patients achieved a partial response, 11% a minor response, and 3% (one patient) had stable disease. Six patients (17%) did not respond to rIFN-alpha 2a. Two patients (6%) achieved a response but later progressed on treatment. A total of 23 patients completed 2 years of treatment and are evaluable for long-term follow-up at a median of 20 months postcompletion of therapy (range 9 to 32 months). Eleven patients (48%) have had progression of their disease at a median of 10 months (range .5 to 25 months) after treatment was discontinued. Statistical analysis of pretreatment patient characteristics did not reveal any factor(s) associated with a high probability of responding to rIFN-alpha 2a; however, analysis of post-treatment variables measured after 2 years of treatment suggested that a low platelet count was associated with a high rate of disease progression. These findings are compared with other published trials using rIFN-alpha 2b, a similar but not identical rIFN preparation. We conclude that while rIFN-alpha 2a has a high overall response incidence, the rate of disease progression after therapy is discontinued approaches 50%, and that a subset of patients can be identified who are at high risk for recurrence after completing 2 years of treatment.

Long term follow-up of BL22 in cladribine-resistant hairy cell leukemia

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 6624-6624
Author(s):  
R. J. Kreitman ◽  
W. H. Wilson ◽  
M. Stetler-Stevenson ◽  
P. Noel ◽  
I. Pastan
Keyword(s):  
Hairy Cell Leukemia ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Long Term Follow Up

Long-Term Follow-Up of Patients With Hairy Cell Leukemia After Cladribine Treatment

Blood ◽  
1998 ◽  
Vol 92 (6) ◽  
pp. 1918-1926 ◽  
Author(s):  
Alan Saven ◽  
Carol Burian ◽  
James A. Koziol ◽  
Lawrence D. Piro
Keyword(s):  
Hairy Cell Leukemia ◽  
Survival Rates ◽  
Complete Response ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Second Neoplasms ◽  
American Society ◽  
La Jolla

Hairy cell leukemia is a chronic B-cell disorder that follows an indolent, but progressive course. Cladribine (2-chlorodeoxyadenosine) induces complete remissions in the majority of patients after a single course. We report the long-term outcomes, including response rates and their duration; time-to-treatment failure (TTF) rates; retreatment results; toxicities; and survival rates of patients treated at Scripps Clinic (La Jolla, CA). A total of 358 patients with hairy cell leukemia were treated with cladribine at 0.087 or 0.1 mg/kg body weight per day by continuous intravenous infusion for 7 days. The expected number of second neoplasms was based on the National Cancer Institute’s Surveillance Epidemiology and End Results data. Of 349 evaluable patients, 319 (91%) achieved an initial complete response and 22 (7%) a partial response with an overall median duration of response follow-up of 52 months. Ninety patients (26%) had relapsed at a median of 29 months. The TTF rate for all 341 responders was 19% at 48 months, 16% for complete responders, and 54% for partial responders. Of 53 evaluable patients treated with second courses of cladribine at first relapse, 33 (62%) achieved complete responses and 14 (26%) partial responses. Twenty-seven patients (8%) developed second neoplasms (only 1 hematopoietic) with an observed-to-expected ratio of 1.88 (95% confidence interval, 1.24 to 2.74). The overall survival rate was 96% at 48 months. Single courses of cladribine induced long-lasting complete responses in the vast majority of patients. Relapse rates for complete responders were low. Patients who relapse can be successfully retreated with cladribine. Cladribine has high efficacy and a favorable acute and long-term toxicity profile when administered to patients with hairy cell leukemia. © 1998 by The American Society of Hematology.

Long-term follow-up studies in hairy cell leukemia

2009 ◽  
Vol 50 (sup1) ◽  
pp. 23-26 ◽  
Author(s):  
Michael R. Grever ◽  
Pier Luigi Zinzani
Keyword(s):  
Hairy Cell Leukemia ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Follow Up Studies ◽  
Long Term Follow Up

Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine (2-CdA): long-term follow-up of the Northwestern University experience

Blood ◽  
2005 ◽  
Vol 106 (1) ◽  
pp. 241-246 ◽  
Author(s):  
Punit Chadha ◽  
Alfred W. Rademaker ◽  
Prateek Mendiratta ◽  
Benjamin Kim ◽  
Darren M. Evanchuk ◽  
...  
Keyword(s):  
Hairy Cell Leukemia ◽  
Progression Free Survival ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Long Term Outcomes ◽  
Northwestern University ◽  
Long Term Follow Up ◽  
University Experience

2-chlorodeoxyadenosine (2-CdA), a purine analog, has become universally accepted as the agent of choice in treating hairy cell leukemia (HCL). However, few studies have reported long-term outcomes after 2-CdA treatment. Between January 1990 and June 2003, 86 consecutive patients with HCL were treated with a single 7-day course of 2-CdA by continuous infusion at a dose of 0.1 mg/kg per day. Of the 86 patients (mean age: 49 years), 67 patients (79%) achieved a complete remission (CR); 18 patients (21%) achieved a partial remission (PR); and 1 patient's response was unable to be assessed. The progression-free survival (PFS) for initial relapse after 12 years was 54%. At a median follow-up of 9.7 years (range, 0.3-13.8 years), 31 (36%) of 85 patients relapsed. There were 23 relapsed patients treated with a second cycle of 2-CdA; 2 patients were treated with alternative agents; and 6 patients were observed. Of the 23 relapsed patients retreated with 2-CdA, 12 (52%) achieved a CR and 7 (30%) patients achieved a PR (overall response rate: 83%). The overall survival (OS) rate after 12 years was 87%. There were 15 patients (17%) who developed other malignancies. Long-term follow-up of up to 14 years (median: 9.7 years) showed an excellent PFS and OS for HCL patients after 2-CdA treatment.

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