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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
Patients with myelodysplastic syndrome
Patients with acute lymphocytic leukemia exclusive of patients in first remission without negative prognostic markers
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a condition called myelodysplastic syndrome.
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You have acute lymphocytic leukemia, except if you are in the first remission without negative prognostic markers.
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You have nonHodgkin's lymphoma or Hodgkin's disease that has come back or has not responded to treatment.
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You have multiple myeloma that has come back after treatment or has not responded to treatment.
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You have chronic lymphocytic leukemia that has come back after treatment or has not responded to treatment.
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You are not eligible for a less intense type of transplantation based on your age, previous transplants, organ function, or type of disease.
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You do not have a donor with a close enough match for a transplant.
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You are between 18 and 75 years old.
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You have a good level of physical ability, rated between 0 and 2.
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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.
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You have acute myeloid leukemia, except if you are in your first complete remission and have specific favorable genetic changes in your leukemia cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 • NCT00385788
92%
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
835 Previous Clinical Trials
13,006,501 Total Patients Enrolled
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,613 Total Patients Enrolled
David E Avigan, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
3 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

Antithymocyte Globulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT00697684 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4
Non-Hodgkin's Lymphoma Clinical Trial 2023: Antithymocyte Globulin Highlights & Side Effects. Trial Name: NCT00697684 — Phase 1
Antithymocyte Globulin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00697684 — Phase 1

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
~2 spots leftby Mar 2025