Clinical trial: NCT03531918
Section: Alternatives
Subsections: What Are The Benefits?|You Have Other Choices Besides This Study.

We do not know if combining GO with GCLAM will help treat AML or high-grade myeloid neoplasms. This particular combination has not been tried before, and we are testing it to find the highest safe dose and to see its effects on people with AML and related diseases. You might get better if you receive these drugs, but your condition could stay the same or even get worse. We hope the information we learn will help people with these diseases in the future.

You do not have to join this study. You are free to say "yes" or "no". Your regular medical care would not change if you decide to say "no".  
You have other choices for treatment. Each of these choices has risks and benefits.  
You should talk to your doctor or healthcare provider about these choices.  
Other choices include:  
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Another research treatment.  
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Standard treatment.  
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No treatment. Comfort care.
Enrollment in this study may exclude you from other research studies.
Clinical trial: NCT03531918
Section: Confidentiality
Subsections: Protecting Privacy As An Individual And The Confidentiality Of Personal Information|How Is My Genetic Information Protected?

If you join this study, some people or organizations might need to look at your medical records and research records for quality assurance or data analysis. They include:  
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Researchers involved with this study.  
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Institutional Review Boards (IRB), including the Fred Hutchinson Cancer Research Center IRB. An IRB is a group that reviews the study to protect the rights and welfare of research participants.  
Fred Hutchinson Cancer Research Center, University of Washington, and
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Seattle Cancer Care Alliance.  
Office for Human Research Protections, Food and Drug Administration and
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other regulatory agencies as required.
We will do our best to keep personal information confidential. But we cannot guarantee total confidentiality. Personal information may be given out if required by law. For example, workplace safety rules may require health workers to contact you about lab tests. Or a court may order study information to be disclosed. Such cases are rare.  
We will not use personal information in any reports about this study, such as journal articles or presentations at scientific meetings.  
If you join this study, information about your participation would be made part of your permanent medical record. This information would include a copy of this consent form. If an insurance company or employer or anyone else were authorized to see your medical record, they would see a copy of this consent form.

A federal law called the Genetic Information Nondiscrimination Act (GINA) helps protect genetic information about people who join research studies.  
GINA restricts access to genetic information so that it cannot be used for health insurance coverage decisions. GINA prevent health insurance companies or group halth plans from
- Asking for genetic information obtained in research studies, or  
- Using genetic information when making decisions regarding your eligibility or premiums
GINA does not help or protect against genetic discrimination by companies that sell life, disability or long term care insurance.
Clinical trial: NCT03531918
Section: Duration of Study Involvement
Subsections: How Long Would You Stay In This Study?

If you join this study, you would stay in it for up to 6-8 months. The exact length of treatment would depend on the side effects and your response to the treatment. If you still have your cancer after GO + GCLAM, you may be eligible to have the GCLAM
component of the therapy repeated. If this were the case, your doctors would discuss this with you. If you do not achieve a good response ("remission") after 2 cycles, you would not be eligible for additional cycles as part of this trial. If you achieve a good response with GO and GCLAM, you would be able to receive up to 3 cycles of additional chemotherapy ("post-remission" chemotherapy) on this study to further decrease the amount of cancer cells that may still be left in your body. The first cycle of this post-remission chemotherapy will consist of GCSF, Cladribine, and Cytarabine (GCLA). These drugs will be dosed the same way they were during the initial treatment as long as you tolerated the treatment. The consolidation would be given after your blood counts are better and you have recovered from side effects that you may have experienced. This recovery usually takes about 1 month. Some doctors or patients may elect to use therapies other than GCLA for your consolidation (e.g. stem cell transplantation), and your doctors would discuss these options after your initial treatment. The second and third cycles of consolidation would be with cytarabine alone, given at 1000 mg/m 2 every 12 hours on days 1-6 for a total of 12 doses. Each cycle would start only after recovery from the previous cycle, which takes about 1 month.  
The study doctor or your doctor may take you out of this study at any time. This would happen if:
They think it is in your best interest not to continue in the study.  
You are not able or willing to follow study procedures.  
The whole study is stopped.
If you withdraw from the study for any reason, previously collected information would remain in the study records and would be included in the analysis of results.  
This information could not be removed from the study records. If you are thinking about dropping out of this study, please tell the study doctor. Long-term follow-up means keeping track of someone's medical condition for a long time. After you have finished the study treatment, you may return to your primary oncologist or choose to receive additional care at the Seattle Cancer Care Alliance (SCCA). After you finish the study, the study doctors may want to know about your health after you leave the SCCA. The study doctors may contact you or your doctor up to every 3 months for 5 years to see how you are doing. We would also ask your doctor to send a copy of your medical records. This information will help us learn about the long-term effects of GO plus GCLAM. You do not have to be in long-term follow-up. You could say "yes" or "no". Either way, you could still join the study. If you drop out of the study, you would be asked if we could call you up to every 3 months for 5 years. If you choose not to join long-term follow-up, you would not be contacted regularly, and we would not ask your doctor to send medical records, but we might still need to contact you for some other reason.
Clinical trial: NCT03531918
Section: Participant Responsibilities
Subsections: Your Responsibilities

If you join this study, you would have some responsibilities.  
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Follow the schedule of study visits and procedures.  
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Takes study medications as directed.
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Prevent pregnancy.
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Tell us about side effects.
Clinical trial: NCT03531918
Section: Participant's Rights
Subsections: Your Rights

You do not have to join this study. You are free to say "yes" or "no".  
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If you get sick or hurt in this study, you do not lose any of your legal rights to sek payment by signing this form.  
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During the study, we might learn new information that you need to know. For example, some information may affect your health or well-being. Other information might make you change your mind about being in this study. If we learn these kinds of information, we would tell you.  
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If you join this study, you would not have to stay in it. You could stop at any time (even before you start). Your regular medical care would not change.  
You would have no penalty for stopping, but it would be better not to join the study if you think that you would change your mind later.  
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If you decide to drop out, we would want you to tell the study doctor. The doctor could tell you about the effects of stopping GO and GCLAM. You and the doctor could talk about the follow-up care and testing that would help the most.  
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Before you leave the study, the doctor might ask you to continue in the follow-up part of the study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT03531918
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Side Effects (Risks)?|Reproductive Risks|Would You Have Extra Costs If You Join This Study?|What If You Get Sick Or Hurt After You Join This Study?

In this part of the consent form, we describe the side effects we expect from the treatments in this study. GO plus GCLAM could cause side effects we do not know about yet. We carefully watch everyone in the study for side effects. If you join the study, we would tell you if we discover new side effects that could affect you.  
This form lists side effects of individual drugs. When we use these drugs together, there may be other side effects.  
Side effects may be mild or very serious. Medicines could be given to help lessen side effects. Many side effects of chemotherapy go away soon after you stop taking the treatment. In some cases, side effects can last a long time or never go away. There also is a risk of death.  
Gemtuzumab ozogamicin Likely side effects (>20% of patients) of GO are:
Abdominal pain
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Weakness
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Chills Fever
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Headache
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Infection
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Diminished appetite
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Constipation
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Diarrhea
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Nausea/Vomiting Mouth sores Low blood counts Low blood potassium levels Difficulty breathing Nose bleeds
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Less likely side effects (3-20% of patients) of GO are:
Back pain
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Fever associated with low white blood cell count (neutropenic fever)
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Pain
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Bleeding/Bruising
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High blood pressure
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Low blood pressure
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Fast heart rate
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Insomnia Cough, sore throat Itching Rash
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Herpes skin infection Local reaction to infusion Rare side effects (<3% of patients)
Abnormal uterine bleeding
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Chemotherapy could cause sterility (unable to have children).  
Taking the study medicines may involve unknown risks to an embryo or fetus
(unborn baby) or nursing infant. Therefore, you could not join this study if you are pregnant, if you are planning to become pregnant, or if you are breastfeeding.  
If you join this study, you would have to use an effective method of birth control from the time this form is signed until at least 3 months after the last dose of study treatment. Examples of effective methods of birth control include, but are not limited to barrier methods (condoms) for either sex and oral contraceptives for women. We would ask that you check with your doctor to make sure the method you choose is effective. If you are already using a method of birth control, you would have to check with the study doctor or a member of the study staff to make sure it is acceptable.  
If you become pregnant after joining this study, you would have to notify the study doctor immediately. Participation in this study would end at that time.  
The effects of fathering a child are also unknown. Men who join this study must also agree to use one or more forms of effective and acceptable birth control from the time this form is signed until at least 3 months after the last dose of study treatment

If you join this study, you would have some extra costs. Your insurance company might pay these costs, but some insurance policies do not cover these costs. We could help find out whether your insurance company would cover these costs.  
The extra costs are:
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Cost of tests that are given more often than usual.
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Cost of the study drugs (except GO).
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Cost of standard doctor visits and lab tests. Cost of any other medical care needed because of this study.
If you join this study, you or your insurance company would have to pay for the costs of standard treatment in this study.  
You would not be billed for:
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GO.

For a life threatening problem, call 911 right away or seek help immediately. Contact your study doctor when the medical emergency is over or as soon as you can.  
For all other medical problems or illness related to this research, immediately contact
. They will treat you or refer study physicians Dr. Roland B. Walter you for treatment. You or your health insurance will have to pay for the treatment.  
There are no funds to pay you for a research-related injury, added medical costs, loss of a job, or other costs to you or your family. State or national law may give you rights to seek payment for some of these expenses. You do not waive any right to seek payment by signing this consent form.  
You or your insurer will be billed for treatment of problems or complications that result from your condition or from clinical care.  
You would not lose any legal right to seek payment for treatment if you sign this form.
Clinical trial: NCT03531918
Section: Procedures
Subsections: What Research Tests, Procedures, And Treatments Are Done In This Study?

If you join this study, we would do these tests and procedures:
Baseline Assessment. You will need tests, including a bone marrow and/or peripheral blood analysis, a heart test, and a physical exam to see if you are eligible for the trial. Please tell your medical team of any past or current medical problems. These tests and physical exam are usually considered part of regular cancer care. If you have recently had some of these tests, they may not need to be repeated. You will also need a central venous catheter inserted to receive chemotherapy and to simplify blood draws and transfusions.  
Collection of research specimens. You will have the option of participating in additional research by providing extra blood or bone marrow specimens to be stored in a repository for future laboratory research, e.g. to understand why some people do/do not respond to this treatment. You do not need to give specimens to participate in the trial. If you do agree to donate specimens for future research, an additional tube of blood or up to 10 ml of bone marrow per bone marrow procedure may be collected for research storage. We would only collect research bone marrow specimens at the time of bone marrow tests done for regular cancer care; extra bone marrow procedures for purposes of research specimen collection will not be required.  
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Study Treatment. You will be assigned to received GO in combination with GCLAM chemotherapy at one of two dosing schedules.  
Dose level 1: will receive a single dose of GO at a dose of 3 mg/m 2
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(maximum dose 4.5 mg) through the vein (IV) on day 1 of GCLAM
chemotherapy. Dose level 2: will receive three doses of GO, each dose at 3 mg/m2
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(maximum dose 4.5 mg), through the vein (IV) on days 1, 4, 7 of GCLAM
chemotherapy.
The first group of 6 patients will be enrolled at dose level 1. If these patients tolerate the treatment, the next group of 6 patients will receive dose level 2. If patients do not tolerate a certain dose level because of bad side effects, we will not give that level in the future. Once the highest tolerated dose level (also called the maximum tolerated dose) of GO plus GCLAM chemotherapy has been identified in a smaller group of patients ("Phase 1"), the remainder of the patients will receive the study treatment at that highest tolerated dose
("Phase 2")
Clinical trial: NCT03531918
Section: Purpose of Research
Subsections: We Invite You To Join This Research Study.|Why Are We Doing This Study?

We invite you to join this research study because you have AML or a related highgrade myeloid neoplasm. Up to 72 people will join this study.  
Research is not the same as treatment or medical care. The purpose of a research study is to answer scientific questions.  
You do not have to be in the study. You are free to say "yes" or "no", or to drop out after joining. If you say "no," you would have no penalty or loss of benefits. Whatever you decide, your regular medical care would not change.

We are doing this study to examine the combination of GO and GCLAM chemotherapy. We want to know if this combination is safe, whether one or three doses of GO in combination with GCLAM is safe, and ultimately whether this combination is an effective treatment for AML and high-grade myeloid neoplasms.  
We are studying GO [trade-marked as Mylotarg]. GO is an antibody-drug conjugate which is FDA-approved for the treatment of AML. We are also studying GCLAM
chemotherapy, which consists of granulocyte colony stimulating factor ("G"),
cladribine ("Cl") [Leustatin], cytarabine ("A") [Cytosar-U] and mitoxantrone ("M")
[Novantrone]. Granulocyte colony stimulating factor is a growth factor used to stimulate leukemia cells and render them more sensitive to chemotherapy drugs, and cladribine, cytarabine and mitoxantrone are all standard chemotherapy drugs used to treat AML and other cancers.  
We have used GCLAM alone widely to treat people with AML and related blood cancers and found it to be safe and effective. GO has been used widely alone or in combination with other chemotherapy drugs for the treatment of the same cancer.  
However, GO and GCLAM together have not yet been tested in people. In this study, we want to learn:
How much GO can be given safely in combination with GCLAM.  
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What effects, good or bad, GO plus GCLAM chemotherapy has on people
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with AML and high-grade myeloid neoplasms.
If you join this study, we would give you GO and GCLAM chemotherapy. People who join at the beginning of the study will receive one single dose of GO together with GCLAM. If we find this dosing safe, people who join later may receive 3 doses of GO together with GCLAM, until effects (good or bad) appear. We will watch carefully for any side effects.