Clinical trial: NCT01059786
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

What other choices do I have if I do not take part in this study? You may choose not to be tested for eligibility or to have any other studies done.
Clinical trial: NCT01059786
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
The NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
National Institutes of Health Intramural Institutional Review Board Qualified representatives from Genentech and Biogen IDEC, the pharmaceutical company who produces rituximab, and Teva Pharmaceutical Industries, the pharmaceutical company who produces bendamustine.
When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court.  
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The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT01059786
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Benefits Of Participation|Policy Regarding Research-Related Injuries

We do not know if you will receive personal medical benefit from allowing us to test your blood or other tissue. However, this testing may make you eligible for our trial of treatment of Hairy Cell Leukemia or Hairy Cell Leukemia variant with pentostatin and rituximab or bendamustine plus rituximab. If you become eligible for our treatment study, you would need to give additional informed consent regarding the risks of the treatment.

The NIH Clinical Center will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided by the NIH, the NIH Clinical Center, or the Federal Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.
Clinical trial: NCT01059786
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?|Specimens To Be Saved For Additional Tests|Bone Marrow Aspirate And/Or Biopsy|Local Anesthesia

Blood samples will be drawn at your local medical doctor or previously obtained bone marrow samples will be sent to NIH. We may collect up to a half-cup of blood to test for your eligibility and collect research samples for this study. Some of these research studies will be performed under the companion protocol 10-C-0066. You will be asked to sign another consent prior to having any samples collected. The following tests or procedures are needed to determine whether you are eligible for this trial:
Medical history: A complete review of your medical history, including obtaining information about your diagnosis and previous treatments, and reviewing information about your other conditions.  
Physical examination including weight and height, and vital signs  
Performance status: an evaluation of your ability to perform everyday activities. Lab blood and urine tests, to check for blood counts, organ function, and for signs of infection.
Pregnancy test in women who can have children. Pregnant women will not be allowed on study.  
Test for hepatitis B and C.  
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HIV test. As part of this study, we will test you for infection with HIV, the virus that causes AIDS. If you are infected with HIV, you will not be able to take part in this study. We will tell you what the results mean, how to find care, how to avoid infecting others, how we report HIV infections, and the importance of informing your partners at possible risk because of your HIV infection Bone marrow biopsy samples, whether they are obtained at NIH or elsewhere, and whether the bone marrow test has already been done or not yet done. Your tumor tissue may be obtained from prior surgeries or from a biopsy that you might elect to have for purposes of determining if you are eligible for this study. Any biopsy or other procedure would be done only if needed and only after you sign an additional informed consent related to the specific procedure.

We would also like to draw blood for the following research studies:  
Neutralizing antibodies: Antibodies a patient might make to certain protein drugs which block their effect against cancer cells. You may or may not consider receiving these protein drugs in the future. Requires about 1 teaspoon.  
Cytotoxicity assays. Hairy cells from the blood or bone marrow may be tested outside the body with anti-cancer drugs to determine if they can be killed. Requires 1-3 tablespoons.  
Soluble CD25, CD22, and other tumor markers: Your hairy cells make these proteins and since they fall off the cells and go into the blood, the blood can be tested for them to estimate the amount of hairy cell leukemia cells in your body. Requires about 1 teaspoon.  
HLA (Human leukocyte antigen) typing to better understand the immune system in patients with hairy cell leukemia/variant. HLA is the human leukocyte antigens, a complex of proteins on your white blood cells which allow your body to determine whether the cell is yours or not. Requires about 1 teaspoon.  
Samples of blood to study certain toxicities of other treatments used for hairy cell leukemia/variant, including hemolytic uremic syndrome (HUS). Requires about 1/2 teaspoon.  
Flow cytometry assays, where your hairy cells are tested with antibodies outside your body to determine how much of each tumor marker is present on the hairy cells. In flow cytometry, your blood after being drawn goes into a tiny tube where lasers determine whether the tumor markers are present and, if so, how much. Requires about 1/2 tablespoon.
You will be given the opportunity to decide whether you want to participate at the time of collection. Assays which could have an impact on both patients and their children, including studies of genetic cancer risk, will not be done. Your research specimens, when sent outside the NIH, will only be identified by the study code, subject number, and date and time of collection.

This involves inserting a needle into a large bone such as the pelvis and removing a small amount of bone marrow fluid (aspiration) and a sample of solid bone marrow tissue (biopsy). The aspiration is usually performed first with a smaller needle than is used in the biopsy. A numbing agent that can cause a stinging or burning sensation may be injected at the site of your bone marrow aspiration/biopsy. The needle will go through the skin into the bone and may produce a brief, sharp pain. As the sample is taken from the bone, there may be a brief, sharp pain. This procedure may cause some discomfort, however not all participants experience discomfort. The entire procedure will take about 1 hour to complete. We will call you about 2 days after the procedure to see how you are doing. The possible side effects associated with a bone marrow aspiration/biopsy include pain, bleeding, bruising, and infection, as well as a reaction to the numbing agent. Soreness near the site may last for a couple of days after the procedure. You may have more pain, risk of bleeding and bruising if you complete both aspiration and biopsy rather than just the aspiration. If your pain is severe or you develop a fever, please contact the study team immediately.

Biopsy may be done under local anesthesia. Potential side effects of local anesthesia include drowsiness, headaches, blurred vision, twitching muscles or shivering, continuing numbness, weakness or pins and needles sensation.
Clinical trial: NCT01059786
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Description Of Research Study

This consent form is to determine your eligibility for our study involving treatment with pentostatin plus rituximab versus bendamustine plus rituximab for multiply relapsed Hairy Cell Leukemia (HCL) and Hairy Cell Leukemia variant (HCLv).

The primary objective of the study is to determine if response in each regimen is higher than what you might expect from rituximab alone, and to determine which regimen might be better. Before the protocol begins to randomize the patients, it will be necessary to make sure the proposed dose of bendamustine plus rituximab, which has been shown to be safe in a similar form of leukemia, is also well tolerated in HCL. 12 patients will therefore receive bendamustine plus rituximab without being randomized. If toxicity is observed in HCL patients which is more than what we would expect from other leukemia patients, the protocol may need to be changed before patients get randomized. Otherwise, the bendamustine-rituximab dose will be considered appropriate and patients will then be randomized to receive either this dose of bendamustine + rituximab, or pentostatin plus rituximab. If you take one treatment, and either get worse or respond but then relapse, you may then 'cross over' to the other regimen, as long as you are still eligible. If you previously received one of the regimens and did not respond, you may receive the other regimen only and you would not be in the groups that would be compared. We first need to determine if you are eligible for this study. You may not yet be eligible for our study with pentostatin and rituximab or bendamustine plus rituximab for several reasons, like having a disease which is not considered hairy cell leukemia/hairy cell leukemia variant, or having results of blood counts which are not in the correct range to be eligible. If so, you may still be eligible in the future. Your blood, bone marrow, tumor or other tissue may also be tested for other factors for research purposes. However, this consent does not permit any additional studies that would test for genes (i.e. tendency for diseases) that might be inherited from you by your children.
Clinical trial: NCT01059786
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.