Your session is about to expire
← Back to Search
Immunosuppressant
Antithymocyte Globulin + Clofarabine for Blood Cancers
Phase 1
Waitlist Available
Led By David E Avigan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
Eligible Conditions
- Relapsed/Refractory Non-Hodgkin's Lymphoma
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Acute Lymphoblastic Leukemia
- Chronic Lymphocytic Leukemia
- Hodgkin's Lymphoma
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lymphocyte immune globulin, anti-thymocyte globulin
Secondary outcome measures
Transplantation, Homologous
To determine the disease free survival and overall survival of patients undergoing allogeneic transplantation following following clofarabine, rabbit ATG, and total lymphoid irradiation.
To determine the incidence of acute and chronic graft versus host disease following clofarabine, rabbit ATG, total lymphoid irradiation, and allogeneic transplantation.
Side effects data
From 2016 Phase 2 trial • 52 Patients • NCT0038578892%
Nausea
75%
Bilirubin
67%
Transaminitis
67%
Mucositis
50%
Pulmonary
50%
Neurologic Pain
42%
Cardiac
33%
Creatinine
33%
Diarrhea
25%
Fever
25%
Acute Renal Failure
25%
Fatigue
17%
Acute Respiratory Failure
17%
Skin Rash
17%
BK Cystitis
8%
Cardiac Dysfunction
8%
Gastrointestional (GI) Bleed
8%
Seizure/Encephalopathy
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fludarabine + Melphalan
Gemcitabine + Fludarabine + Melphalan
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 4Experimental Treatment2 Interventions
Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 40mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 200 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
Group II: Cohort 3Experimental Treatment2 Interventions
Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 30mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 150 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
Group III: Cohort 2Experimental Treatment2 Interventions
Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 20mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 100 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
Group IV: Cohort 1Active Control1 Intervention
Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte Globulin
2000
Completed Phase 3
~180
Clofarabine
2007
Completed Phase 3
~1130
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,010,411 Total Patients Enrolled
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,591 Total Patients Enrolled
David E Avigan, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
3 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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)."
Answered by AI
Does the FDA sanction Antithymocyte Globulin?
"Antithymocyte Globulin is still in the early stages of testing, so it received a score of 1."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger