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Antithymocyte Globulin + Clofarabine for Blood Cancers
Study Summary
This trial will study the safety of using clofarabine, TLI and ATG as a reduced conditioning regimen prior to allogeneic (between individuals) transplantation. The study will also look at the impact of the conditioning regimen on the presence of regulatory T cells (which help keep the immune system in check) as compared to activated T cells.
- Relapsed/Refractory Non-Hodgkin's Lymphoma
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Acute Lymphoblastic Leukemia
- Chronic Lymphocytic Leukemia
- Hodgkin's Lymphoma
- Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 52 Patients • NCT00385788Trial Design
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Who is running the clinical trial?
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- You have HIV.You have a serious illness or infection that could make a transplant too risky.You have multiple myeloma that has come back after treatment or has not responded to treatment.You have a condition called myelodysplastic syndrome.Your lung function test shows that your ability to transfer oxygen into your blood is more than 50% of what is expected for someone like you.You have been exposed to hepatitis B or C and need to have a liver biopsy to check for active hepatitis or liver scarring before being considered for a transplant.Women who can have babies must have a recent negative pregnancy test before joining the study.You have acute myeloid leukemia, except if you are in your first complete remission and have specific favorable genetic changes in your leukemia cells.Your heart pumps out at least 40% of the blood in each heartbeat.You have acute lymphocytic leukemia, except if you are in the first remission without negative prognostic markers.You have nonHodgkin's lymphoma or Hodgkin's disease that has come back or has not responded to treatment.You have chronic lymphocytic leukemia that has come back after treatment or has not responded to treatment.You are not eligible for a less intense type of transplantation based on your age, previous transplants, organ function, or type of disease.You do not have a donor with a close enough match for a transplant.You are between 18 and 75 years old.You have a good level of physical ability, rated between 0 and 2.Your blood test results for bilirubin, AST/ALT/Alkaline Phosphatase, and serum creatinine need to be within certain levels.
- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How is Antithymocyte Globulin typically employed?
"Antithymocyte Globulin can be used to treat refractory acute lymphoblastic leukemia (ALL), leukemia, myelocytic, acute, and relapsed acute lymphoblastic leukemia (ALL)."
Does the FDA sanction Antithymocyte Globulin?
"Antithymocyte Globulin is still in the early stages of testing, so it received a score of 1."
Is this particular clinical trial open to people who are middle-aged?
"The age range for this specific clinical trial is 18 to 75. If you don't qualify for this trial, there are 598 other trials for patients under 18 and 2377 trials for patients over 65."
Who meets the prerequisites to sign up for this test program?
"Lymphoma patients that are also under 75 years old can qualify for this study. Around 30 patients will be taken in for testing."
What sets this particular clinical trial apart from others?
"Since 2008, Antithymocyte Globulin has been the focus of 25 active clinical trials in 306 cities across 15 countries. The first study was conducted in 2008 by Genzyme, a Sanofi Company. Following the Phase 1 trial, which had 30 participants, Antithymocyte Globulin received drug approval."
What are the most significant findings from other research projects that have used Antithymocyte Globulin?
"There are 4 Phase 3 trials and 25 clinical studies in total for Antithymocyte Globulin. The majority of these studies are situated in Hershey, but there are 581 locations conducting research for Antithymocyte Globulin worldwide."
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