Alemtuzumab in Combination With Etoposide and Dexamethasone
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Alemtuzumab (Drug); Etoposide (Drug); Dexamethasone (Drug); Methotrexate (Drug); Phone Call (Behavioral)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Naval Daver, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact: Naval Daver, MD, Phone: 713-794-4392
Summary
The goal of this clinical research study is to learn the if the drug combination of
alemtuzumab, etoposide and dexamethasone can help to control HLH. The safety of the drug
combination will also be studied.
Clinical Details
Official title: Alemtuzumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate (ORR) of Alemtuzumab in Combination with Etoposide and Dexamethasone in Participants with Hemophagocytic Lymphohistiocytosis (HLH).
Detailed description:
Study Treatment:
If you are found to be eligible to take part in this study, you will receive the study
treatment in 2 parts. The first part of the study will last about 8 weeks (Weeks 1-8) and
will be called the "induction phase". The second part of the study will start after the
induction phase and will last about 16 weeks (Weeks 9-16). This part will be called the
"maintenance phase". However, the parts of the study may be longer or shorter depending on
if/how the disease responds to the treatment, how the biomarkers react to treatment, and
what the doctor thinks is in your best interest.
You will receive alemtuzumab by vein or through an injection under the skin every day on
Days 1-4 of the induction phase and about 1 time every 4 weeks during the maintenance phase.
You will receive etoposide by vein about 1 time each week during the induction phase. You
will not receive it in the maintenance phase unless the disease stops responding to the
study drugs. At that point, you may begin to receive etoposide again. The study doctor
will tell you more about this.
The length of time it takes to infuse the study drugs will be different from patient to
patient and will depend on rate of injection. Your doctor will discuss this with you.
You will receive dexamethasone by vein on Days 1-7 of the induction phase. After this, you
will take pills of dexamethasone every day during the induction phase. In the maintenance
phase, you will take these pills 3 times each week with at least a day between each dose
(for example, Monday, Wednesday, and Friday).
Your dose of the study drugs may be raised, lowered, and/or delayed if the doctor thinks it
is in your best interest.
If the disease involves the central nervous system, you may receive methotrexate.
Study Visits:
You will have physical exams on the following days:
- Day 1,
- Every week for the first 4 weeks,
- Every 2 weeks during the next 4 weeks,
- Every 4 weeks during the next 16 weeks, and
- Every 8 weeks after that.
Blood (about 3 tablespoons) will be drawn for routine tests on the following days. During
the first 4 weeks, these tests must be performed at MD Anderson. After that, these can be
performed at a local clinic:
- Day 1,
- Two (2) times each week for the first 4 weeks,
- Every week for the next 4 weeks,
- Every 2 weeks for the next 16 weeks, and
- Every 4 weeks after that.
You will have a bone marrow aspiration/biopsy 4 weeks after starting the study treatment and
then every 4-12 weeks after that.
At any time that the doctor thinks it is needed, you may have additional blood draws or bone
marrow aspirations/biopsies to check the status of the disease. If you receive treatment
for longer than 24 weeks, the timing of these procedures may be changed if the study doctor
thinks it is in your best interest.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
End-of-Study Visit:
If you are taken off or if you leave the study before you have received treatment for 24
weeks, the following tests and procedures will be performed within 30 days (+/- 7 days) of
the last dose of the study drug:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a bone marrow aspirate to check the
status of the disease.
If you cannot make it to MD Anderson for this visit, these procedures may be done with a
local doctor and the records can be forwarded to the study doctor.
Follow-Up:
If you respond to the study drugs, you will be followed every 3-6 months for up to 5 years
after completion of treatment. You will be called and asked about how you are doing. Each
call will last about 5-10 minutes.
This is an investigational study. Alemtuzumab, etoposide, and dexamethasone are not FDA
approved for the treatment of HLH. Etoposide is FDA approved and commercially available for
the treatment of testicular cancer and lung cancer. Alemtuzumab is FDA approved and
commercially available for the treatment of chronic lymphocytic leukemia. Dexamethasone is a
steroid used to reduce inflammation. The combination of alemtuzumab, etoposide, and
dexamethasone to treat HLH is investigational. The study doctor can explain how the drugs
are designed to work.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Sign an IRB-approved informed consent document.
2. Patients of all ages will be included.
3. Diagnosis of hemophagocytic lymphocytosis, either newly diagnosed or
relapsed/refractory.
4. Organ function as defined below (unless due to the HLH process): Serum creatinine =
3. 0 mg/dL, Total bilirubin = 5. 0 mg/dL. If organ dysfunction is thought to be
related to the HLH process this must be clearly documented in the chart and the
patients may be enrolled on study irrespective of creatinine and bilirubin levels.
5. Women of childbearing potential must practice contraception. Females of childbearing
potential: Recommendation is for 2 effective contraceptive methods during the study.
Adequate forms of contraception are double barrier methods (condoms with spermicidal
jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or
injectable contraceptives, intrauterine devices, and tubal ligation. Male patients
with female partners who are of childbearing potential: Recommendation is for male
and partner to use at least 2 effective contraceptive methods, as described above,
prior to study entry and for at least 3 months after the last dose of study drug.
6. Negative urine pregnancy test and/or serum pregnancy test within 7 days of initiation
of therapy.
7. Male patients with female partners who are of childbearing potential: Recommendation
is for male and partner to use at least 2 effective contraceptive methods, as
described above, prior to study entry and for at least 3 months after the last dose
of study drug.
Exclusion Criteria:
1. Pregnant and breast feeding women
2. Any serious/and or unstable pre-existing medical disorder (aside from malignancy
exception above), psychiatric disorder, or other conditions that could interfere with
subject's safety, obtaining informed consent or compliance to the study procedures
3. Patients unwilling or unable to comply with the protocol.
Locations and Contacts
Naval Daver, MD, Phone: 713-794-4392
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Not yet recruiting
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: August 2015
Last updated: March 5, 2015
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