Cladribine + Rituximab for Hairy Cell Leukemia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: HIV, Hepatitis B, CNS metastases, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial studies how well two drugs, cladribine and rituximab, work together in treating patients with hairy cell leukemia. Cladribine helps stop cancer cells from growing, while rituximab helps the immune system attack cancer cells. The combination aims to be more effective in treating this type of leukemia.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken any investigational agents or chemotherapy in the last 4 weeks before starting the trial.
What data supports the effectiveness of the drug combination Cladribine and Rituximab for treating Hairy Cell Leukemia?
Research shows that Cladribine is highly effective for treating Hairy Cell Leukemia, achieving excellent remission rates, though some patients may relapse. Rituximab has been successful in treating relapsed cases and can help clear minimal residual disease, potentially improving long-term outcomes.
12345Is the combination of Cladribine and Rituximab safe for treating Hairy Cell Leukemia?
Rituximab has been used safely in patients with Hairy Cell Leukemia, with some experiencing mild to moderate side effects like febrile neutropenia (fever with low white blood cell count) and reversible blood clotting issues. Cladribine has also been used effectively with a high response rate, and while relapses can occur, it is generally well-tolerated.
24567How is the drug combination of Cladribine and Rituximab unique for treating hairy cell leukemia?
The combination of Cladribine and Rituximab is unique because Cladribine is a standard first-line treatment that effectively induces remission, while Rituximab, a monoclonal antibody targeting CD20, helps clear minimal residual disease (small amounts of cancer cells that remain) and is effective in relapsed cases, potentially reducing the likelihood of relapse.
12589Eligibility Criteria
This trial is for adults with hairy cell leukemia who may have had one prior therapy. They must not be pregnant and should agree to use birth control. Participants need a performance status of <=3, acceptable kidney and liver function tests, and no recent investigational drugs or active infections.Inclusion Criteria
Bilirubin less than or equal to 3.0
Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
I am 18 years old or older.
+6 more
Exclusion Criteria
I have been diagnosed with HIV, hepatitis B, or hepatitis C.
My cancer has spread to my brain or spinal cord.
My heart condition severely limits my daily activities.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive cladribine intravenously over 2 hours once daily for 5 days, followed by rituximab IV once weekly for 8 weeks beginning on day 28
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Every 3 months
Participant Groups
The study is testing the combination of Cladribine (a chemotherapy drug) with Rituximab (an immunotherapy antibody) to see if they work better together in treating hairy cell leukemia by killing cancer cells or stopping their growth.
1Treatment groups
Experimental Treatment
Group I: Treatment (cladribine and rituximab)Experimental Treatment3 Interventions
Patients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
Cladribine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Leustatin for:
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
- Multiple sclerosis
🇪🇺 Approved in European Union as Litak for:
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia. [2021]Single-agent purine analog, usually cladribine, has been the standard first-line therapy of hairy cell leukemia (HCL) for 30 years. High complete remission (CR) rates often include minimal residual disease (MRD), leading to relapse and repeated treatments. Rituximab can clear MRD, but long-term results are unknown and optimal timing of rituximab undefined.
Rituximab: a useful drug for a repeatedly relapsed hairy cell leukemia patient. [2015]We describe a case of complete response in a patient with hairy cell leukemia, relapsed after treatment with interferon-alpha, 2'-deoxycoformicin, and 2-chlorodeoxyadenosine, and then successfully treated with rituximab. A fourfold reduction of leukemic cells was observed concomitantly with restoration of normal blood count and differential.
2-CdA in the treatment of hairy cell leukemia: a review of long-term follow-up. [2019]Hairy cell leukemia is a rare, indolent, chronic lymphoproliferative disorder characterized by the proliferation of a malignant B-cell clone with irregular cytoplasmic projections. Treatment with purine analogs such as 2-chlorodeoxyadenosine (2-CdA) is associated with excellent remission rates and long-term survival. Although the majority of patients achieve a complete remission (CR), most have minimal residual disease detected by sensitive methods. Despite the long term disease-free survival, approximately 36% of patients relapse and many require further therapy. Repeat administration of 2-CdA is very effective in achieving a second CR. Recently, new agents such rituximab and BL22 were shown to be effective in the treatment of relapsed and refractory disease.
Bendamustine and rituximab in relapsed and refractory hairy cell leukemia. [2022]To determine tolerability and for the first time explore efficacy of bendamustine-rituximab (BR) in multiply relapsed/refractory hairy cell leukemia (HCL), using two different dose levels of bendamustine.
Multiply relapsing hairy cell leukemia responsive to repeated courses of rituximab: a case report. [2015]While cladribine is a highly effective therapy for patients with symptomatic hairy cell leukemia (HCL), up to 37% of patients ultimately relapse and incompletely responding patients relapse more frequently. Rituximab is a monoclonal antibody against CD20 that has been shown to be effective in patients with relapsed HCL. We present an unusual case of successful multiple re-treatments with rituximab in a patient with heavily pre-treated HCL and briefly review the relevant literature.
Phase 2 study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia. [2021]Hairy cell leukemia (HCL) is an indolent B-cell neoplasm, strongly expressing CD20. Despite initial very high response rates following cladribine, many patients (pts) ultimately relapse. Having relapsed after prior treatment with cladribine, 24 HCL pts (21 male, 3 female) with a median age of 53.5 years were treated with rituximab at 375 mg/m2 intravenously weekly for 4 weeks. Of the pts, 3 (13%) achieved complete remissions and 3 (13%), partial responses. Thus, 6 (25%) of 24 pts achieved a response following rituximab. At a median follow-up of 14.6 months, 2 responders have relapsed; median time to relapse was not yet reached. The only grade III or IV toxicities demonstrated were culture-negative febrile neutropenia, transient and reversible disseminated intravascular coagulation related to rituximab administration, and a diverticular abscess, each in single patients. Of 18 nonresponders, 9 pts subsequently received other treatments; 5 pts were retreated with cladribine, 3 underwent splenectomy, and 1 received pentostatin. Follow-up data are available on 7 of these 9 patients; all 7 patients achieved improvements in hematologic parameters. Rituximab, administered at this dose and schedule, has only modest single-agent activity in cladribine-failed HCL patients when compared with other agents active in this disease.
A population-based study of hairy cell leukemia over a period of 20 years. [2021]There are limited population-based studies of hairy cell leukemia (HCL), a rare chronic lymphoproliferative disorder of B-cells. We conducted a population-based study that included all patients diagnosed with HCL between 1996 and 2016 in Western Normandy. Recorded data focused on medical history, clinical presentation, biological results, treatment modalities in the first line and in relapsed/refractory patients and the occurrence of secondary malignancies. One hundred and twenty-three HCL patients were registered in the database. HCL represented 0.7% of all malignant hematological disorders and 3.0% of all leukemia. The overall age-standardized incidence ratio (SIR) was 0.39/100,000 inhabitants in men and 0.09/100,000 in women, and it remained stable over the 20-year period analyzed. One hundred and seven patients (88%) received first-line treatment, 33 patients (27%) received at least 2 lines of treatment and 14 patients (11%) received more than 2 lines. Cladribine used as first-line treatment induced a high hematological complete response (HCR) rate of 92%. The median overall survival (OS) was over 15 years, with 5-year and 10-year survival rates of 84% and 70.5%. No significant differences in OS were observed between men and women, between the calendar periods studied or between patients who received a single line treatment with IFN-α or PNA. The risk of relapse was higher with IFN-α treatment, requiring subsequent treatments in that patients. The time to next treatment (TTN) tends to be longer for PNAs compared to IFN-α even if difference is not significant. Secondary cancers were observed in 9/123 patients (7.3%) with solid tumors in 8 patients and hematological malignancy in one patient. Our data confirm in real life that single courses of cladribine administered to patients with HCL induce high response rates, the majority of which are HCR. Relapses seem less frequent than with IFN-α and the administration schedule is less restrictive for the patients. The emergence of chemo-immunotherapy and the development of effective new drugs such as recombinant immunotoxins and BRAF targeting will offer new possibilities in the management of HCL patients.
Interferon-alpha is a very effective salvage therapy for patients with hairy cell leukemia relapsing after cladribine: a report of three cases. [2021]Therapy with a purine analogue (cladribine or pentostatin, most often cladribine) has revolutionized the care of patients with hairy cell leukemia, resulting in very long-lasting remissions in the majority of cases. For patients who relapse, re-induction with cladribine again induces durable remissions. For patients with short remission durations, rituximab can be effective, and for a small proportion of patients with more resistant disease, BL22 has been used successfully. I report three cases in which alpha interferon induction and maintenance has produced ongoing remissions in patients with short remission durations after cladribine. One patient had also not responded to rituximab. Alpha interferon may be a very effective treatment option for selected patients with relapsed hairy cell leukemia.
Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine via the Group C protocol mechanism of the National Cancer Institute: a report of 979 patients. [2022]To provide cladribine (CdA) to physicians for the treatment of patients with previously treated or untreated hairy cell leukemia (HCL), and to determine the response rate, response duration, survival, and toxicity with this agent.