Clinical Trials el pt

Rituxan plus HDMP

Date: August 15, 2024

by P. C. Venkat

Status of Clinical Trial

Related Articles:
Rituxan plus Prednisone;
Prednisone, the Good, the Bad and the Downright Ugly;
Topics Alert # 57: R plus HDMP.

This information was presented in TOPICS ALERT Number 37 dated August 14, 2024.

In two recent Topics Alerts (7/28/04 and 8/12/04) we discussed the potential for adverse effects with the Rituxan + HDMP combination. The information I received suggested that there was concern among the researcher community regarding the risk versus benefit of this therapy combination as frontline therapy. I wrote to Dr. Tom Kipps of UCSD to get clarification whether this clinical trial is still open. My letter to him as well as his response are attached below. Please note the detailed listing of inclusion and exclusion criteria. In the interest of wide distribution of this information, this is being sent out as a Topics Alert as well as published on the CLL Topics website. We thank Dr. Kipps for his prompt response to our query.

It appears the clinical trial is still open, formally. But I am told by one of the currently registered patients that there may not be new patients recruited into this trial unless any of the presently recruited patients drop out for whatever reason, and therefore additional slots open up.

Independent of its use as salvage therapy for heavily pre-treated CLL patients, it is still the opinion of this layperson reporter that R + HDMP as frontline therapy may not be a slam dunk choice, and patients should consider it carefully in the context of other therapy options that may be open to them. The term "Buyer Beware" is very much applicable when shopping for therapy options. I would also like to reiterate my concern about patients using this combination "off-label" with the help of their local oncologists. Without the careful monitoring possible in the clinical trial setting, there may be risk factors that are not adequately supervised "off-label". In other words, don't do this at home!  

Correspondence:

August 11, 2024

Dear Dr. Kipps:

I think you are aware of our website clltopics.org .  We try to help our patient-members be aware of their therapy options, as well as better evaluate clinical trials for which they may be eligible.

There is a great deal of interest in the Rituxan + HDMP clinical trial that is being conducted at UCSD.  Specifically, with reference to chemo-naive patients, we would like to know if this trial is still open and if you and your colleagues at UCSD are still recruiting CLL patient volunteers for this therapeutic combination as frontline therapy.

We hope you will respond to this query, since we would like to publish your response on our website, make sure the record is accurate.  My contact information is below for your reference.  Thank you for your attention.

Yours sincerely,

Chaya Venkat
President
CLL Topics, Inc.
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Dear Dr. Venkat,

Thank you for your interest in the HDMP + Rituxan protocol for chemo-naive patients who have CLL.  The protocol is open and accruing patients here at UCSD.

For your information, here are the inclusion and exclusion criteria for patients on this study.

Thank you again for your interest.

Sincerely,

Tom Kipps 
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INCLUSION CRITERIA 

• Diagnosis of CLL or PLL
• Lymphocytosis of >5,000 monoclonal B-cells co-expressing >1 B cell marker (CD19,CD20, OR CD23) and CD5; AND
• Bone marrow with >30% of mononuclear cells being lymphocytes.
• Subjects with intermediate or high risk CLL by modified Rai criteria with no previous treatments.
• Subjects must have an indication for treatment as defined by the NCI working group guidelines:
• Massive splenomegaly; or
• Massive lymph nodes, nodal clusters or progressive lymphadenopathy; or
• Grade2 or 3 fatigue; or
• Fever >100.5F or night sweats for greater than 2 weeks without  documented infection; or
• Presence of weight loss >10% over preceding six months; or
• Progressive lymphocytosis with an increase of >50 % over a 2 month period or an anticipated doubling time of less than 6 months.
• Subjects must be 18 years of age or older
• ECOG performance status of 0-2
• Normal renal and hepatic function
• Give informed consent.
• Women of child bearing age must have negative urine pregnancy test and agree to use a medically accepted form of contraception during study.

EXCLUSION CRITERIA

• Previous treatment  with chemotherapy, high dose corticosteroids' or monoclonal antibodies ( Campath 1-H and/or Rituximab) prior to entering study
• Hapatitis B Ag positive and Hepatitis C positive  patients.
• HIV patients
• History of diabetes
• Patients with fasting blood glucose to or over 126 mg/dcl
• Patients with history of gestational diabetes
• Patients with Autoimmune Hemolytic Anemia or thrombocytopenia
• Concurrent malignancy (excluding treated basal and squamous cell skin cancers
• Active fungal, bacterial, and/or viral infection.
• History of peptic ulcer disease with GI bleeding within the last six months
• Untreated metabolic disorders such as hypothyroidism, diabetes, and Cushing's disease
• Focal neurologic defects, seizure disorder, active psychiatric disorder, or history of steroid induced psychosis
• Estimated life expectancy of less than 3 months by the Investigator's best clinical judgement.
• Serious medical condition that would render the subject medically unstable
• Women who are pregnant or breast-feeding
• History of Pancreatitis or hyperlipidemia
• History of Diverticulitis

Thomas J. Kipps, M.D., Ph.D.
Professor and Deputy Director for Research
Rebecca and John Moores Cancer Center
University of California, San Diego
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