Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders
1 other identifier
interventional
48
1 country
1
Brief Summary
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 21, 2003
CompletedFirst Posted
Study publicly available on registry
October 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedResults Posted
Study results publicly available
February 25, 2011
CompletedAugust 7, 2012
August 1, 2012
3.9 years
October 21, 2003
September 25, 2009
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response
Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.
After each 4 week course of treatment
Study Arms (1)
Campath-1H + Rituximab
EXPERIMENTALCampath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Interventions
15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.
Eligibility Criteria
You may qualify if:
- Age \>/=15 years.
- Written informed consent.
- Patients with chronic lymphoid malignancies that are either refractory to frontline therapy or have relapsed and that have a predicted probability of response of less than 20% with conventional therapy or allogeneic/autologous stem cell transplantation.
- The following histologies are included: B-cell chronic lymphocytic leukemia (B-CLL or B-cell CLL), B-cell prolymphocytic leukemia (PLL), chronic lymphoid leukemia (CLL/PLL), hairy cell leukemia and hairy cell variant, mantle cell leukemia/lymphoma, marginal zone lymphoma/leukemia, splenic lymphoma with villous lymphocytes, CLL with evidence of transformation (e.g., Richter's transformation), large granular lymphocytic leukemia (LGL and NK-cell type).
- Patients with above mentioned histologies whose malignant cell population have expressed both CD52 and CD20 in \>/= 20% of cells as assessed by flow cytometry or immunohistochemistry. Expression of CD20 or CD52 \< 20% is permitted if patients received rituximab or alemtuzumab, respectively, within 3 months prior to study start.
You may not qualify if:
- Patients who have previously received Rituximab and CAMPATH-1H in combination are excluded.
- ECOG performance status of \</= 2.
- Serum creatinine \</= 2mg/dL and total bilirubin of £ 2 mg/dL unless due to direct infiltration of the liver or kidney with malignant cells.
- Patients with a past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies are excluded \<CDR = complementarity determining regions\>.
- Negative pregnancy test (serum or urine) if female and of childbearing potential only (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized).
- No prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. No prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
- Patients at high risk of hepatitis B virus (HBV) infection and active HBV infection are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Bayercollaborator
Study Sites (1)
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alessandra Ferrajoli, MD, BS / Assistant Professor
- Organization
- The University of Texas M. D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra Ferrajoli, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2003
First Posted
October 22, 2003
Study Start
October 1, 2002
Primary Completion
September 1, 2006
Study Completion
August 1, 2007
Last Updated
August 7, 2012
Results First Posted
February 25, 2011
Record last verified: 2012-08