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Trial Title:
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
NCT ID:
NCT00412594
Condition:
Hairy Cell Leukemia
Recurrent Hairy Cell Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Hairy Cell
Rituximab
Antineoplastic Agents, Immunological
Cladribine
2-chloro-3'-deoxyadenosine
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cladribine
Description:
Given IV
Arm group label:
Treatment (cladribine and rituximab)
Other name:
2-CdA
Other name:
2CDA
Other name:
CdA
Other name:
Cladribina
Other name:
Leustat
Other name:
Leustatin
Other name:
Leustatine
Other name:
RWJ-26251
Intervention type:
Other
Intervention name:
Laboratory Biomarker Analysis
Description:
Correlative studies
Arm group label:
Treatment (cladribine and rituximab)
Intervention type:
Biological
Intervention name:
Rituximab
Description:
Given IV
Arm group label:
Treatment (cladribine and rituximab)
Other name:
ABP 798
Other name:
BI 695500
Other name:
C2B8 Monoclonal Antibody
Other name:
Chimeric Anti-CD20 Antibody
Other name:
CT-P10
Other name:
IDEC-102
Other name:
IDEC-C2B8
Other name:
IDEC-C2B8 Monoclonal Antibody
Other name:
MabThera
Other name:
Monoclonal Antibody IDEC-C2B8
Other name:
PF-05280586
Other name:
Rituxan
Other name:
Rituximab ABBS
Other name:
Rituximab Biosimilar ABP 798
Other name:
Rituximab Biosimilar BI 695500
Other name:
Rituximab Biosimilar CT-P10
Other name:
Rituximab Biosimilar GB241
Other name:
Rituximab Biosimilar IBI301
Other name:
Rituximab Biosimilar JHL1101
Other name:
Rituximab Biosimilar PF-05280586
Other name:
Rituximab Biosimilar RTXM83
Other name:
Rituximab Biosimilar SAIT101
Other name:
rituximab biosimilar TQB2303
Other name:
rituximab-abbs
Other name:
RTXM83
Other name:
Truxima
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Farhad Ravandi-Kashani, MD
Phone:
713-792-7305
Email:
fravandi@mdanderson.org
Investigator:
Last name:
Farhad Ravandi-Kashani, MD
Email:
Principal Investigator
Start date:
June 10, 2004
Completion date:
June 30, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00412594
http://www.mdanderson.org
