Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

May 22, 2023 updated by: M.D. Anderson Cancer Center

Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Farhad Ravandi-Kashani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Rituximab
Given IV
Other Names:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • Rituximab ABBS
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • rituximab biosimilar TQB2303
  • rituximab-abbs
  • RTXM83
  • Truxima
Drug: Cladribine
Given IV
Other Names:
  • 2-CdA
  • CdA
  • 2CDA
  • Cladribina
  • Leustat
  • Leustatin
  • Leustatine
  • RWJ-26251

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 weeks
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.
Up to 1 year
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.
Up to 4 weeks after the last dose of rituximab
Efficacy of rituximab on prolongation of event-free survival
Time Frame: Up to 1 year
Up to 1 year
Efficacy of rituximab on prolongation of overall survival
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Farhad Ravandi-Kashani, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2004

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0223 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2012-01394 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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