Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
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| ClinicalTrials.gov Identifier: NCT00412594 |
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Recruitment Status :
Recruiting
First Posted : December 18, 2006
Last Update Posted : May 23, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hairy Cell Leukemia Recurrent Hairy Cell Leukemia | Drug: Cladribine Other: Laboratory Biomarker Analysis Biological: Rituximab | Phase 2 |
PRIMARY OBJECTIVES:
I. To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia.
II. To examine the efficacy of rituximab to eradicate minimal residual disease (MRD) after cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).
III. To examine the effect of addition of rituximab to cladribine on the long term disease-free (DFS) and overall survival (OS) (as compared with historical controls).
IV. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF).
OUTLINE:
Patients receive cladribine intravenously (IV) over 2 hours once daily (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.
After completion of study treatment, patients are followed up every 3 months for 1 year.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia |
| Actual Study Start Date : | June 10, 2004 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (cladribine and rituximab)
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.
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Drug: Cladribine
Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Biological: Rituximab Given IV
Other Names:
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- Efficacy of rituximab on achievement of complete response after therapy with cladribine [ Time Frame: At 12 weeks ]Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
- Monitoring the related toxicity for the therapy Grade 3-4 [ Time Frame: Up to 1 year ]Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
- Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood [ Time Frame: Up to 4 weeks after the last dose of rituximab ]The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.
- Efficacy of rituximab on prolongation of event-free survival [ Time Frame: Up to 1 year ]
- Efficacy of rituximab on prolongation of overall survival [ Time Frame: Up to 1 year ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years and older
- Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination
- Patients with relapsed disease are eligible if they have had no more than one prior therapy
- Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
- Performance status =< 3
- Creatinine less than or equal to 2.0 unless related to the disease
- Bilirubin less than or equal to 3.0
- Transaminases less than or equal 3 x upper limit of normal unless related to the disease
- No prior investigational agent in the 4 weeks prior to initiation of therapy
Exclusion Criteria:
- Unable or unwilling to sign the consent form
- Known infection with human immunodeficiency virus (HIV), hepatitis B or C
- Presence of active infection
- Presence of central nervous system (CNS) metastases
- New York Heart Association classification III or IV heart disease
- Prior chemotherapy (last 4 weeks)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412594
| Contact: Farhad Ravandi-Kashani | 713-792-7305 | fravandi@mdanderson.org |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Farhad Ravandi-Kashani 713-792-7305 fravandi@mdanderson.org | |
| Principal Investigator: Farhad Ravandi-Kashani | |
| Principal Investigator: | Farhad Ravandi-Kashani | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00412594 |
| Other Study ID Numbers: |
2004-0223 NCI-2012-01394 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2004-0223 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 18, 2006 Key Record Dates |
| Last Update Posted: | May 23, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Leukemia Leukemia, Hairy Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Antineoplastic Agents, Immunological Cladribine 2-chloro-3'-deoxyadenosine |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Antirheumatic Agents Immunosuppressive Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |