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Immunosuppressant

Personalized rATG for Leukemia

Phase 2
Recruiting
Led By Kevin Curran, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2 - 12 years 133 +/- 27
Adequate organ function is required, defined as follows:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test if a conditioning regimen that includes P-rATG helps the immune system recover sooner and decreases the chances of transplant-related side effects.

Who is the study for?
This trial is for children and adults with acute leukemia or myelodysplastic syndrome (MDS) who are preparing for their first bone marrow transplant. Participants must have certain levels of disease remission, normal organ function, and be able to tolerate cytoreduction. Pregnant or breastfeeding women, those with active brain cancer or uncontrolled infections, HIV/HTLV-positive individuals, and previous transplant recipients cannot join.Check my eligibility
What is being tested?
The study tests if a personalized rabbit Anti-thymocyte Globulin (rATG) in the conditioning regimen before a bone marrow transplant can improve immune recovery and reduce side effects. Patients will receive rATG along with chemotherapy combinations and possibly total body irradiation.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to rATG, increased risk of infections due to immune suppression, symptoms from chemotherapy like nausea, fatigue, hair loss, mouth sores; and complications from radiation such as skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 12 years old.
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My organs are functioning well.
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I am physically active and can care for myself.
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My heart's pumping ability is normal or above normal.
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I can undergo a procedure to reduce tumor size.
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I am 16 or older and mostly can take care of myself.
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I am a male aged 13-21 years.
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My kidney function is within the required range for the trial.
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I am a female aged 13-21 years.
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My leukemia is in remission and minimal residual disease is under 5%.
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My risk score is intermediate or higher for my condition.
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I am between 4 and 60 years old.
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I have MDS with at least one specific condition.
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My lung function tests are above 50% of what's expected, or my oxygen levels are above 92% without extra oxygen.
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I am under 16 and mostly active.
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I am getting a specific stem cell transplant for my blood cancer.
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I am of the required age for the trial.
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I have a severe blood cell count issue.
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My child's cancer does not show signs of minimal residual disease.
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My kidney function is normal for my age.
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My tests show genetic changes that could lead to a severe type of leukemia.
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My age does not limit my participation in Regimen B.
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My AML is in early remission or a later relapse, with minimal remaining disease.
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My leukemia is in remission but at high risk of returning, or it's in its second or later remission.
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My bilirubin levels are 2 mg/dL or lower, or I have a condition that causes high bilirubin.
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My condition is not a result of treatment for another cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of patients who achieve CD4+IR
Secondary outcome measures
Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: P-rATG with total body irradiation, thiotepa, cyclophosphamideExperimental Treatment5 Interventions
P-rATG days (always starting on Day -12 to -10) Hyper fractionated total body irradiation (1375 - 1500cGy*) Day -9 to -6 Thiotepa (5mg/kg/day x 2 day) Day -5 to -4 Cyclophosphamide (60mg/kg/day x 2 days) Day -3 to -2 GCSF Day +7 *TBI dose in 125cGy fractions (with lung shielding) and total dose to be determined by treating physician/radiation oncology and is based off age, stage of disease, and anesthesia requirements.
Group II: P-rATG with busulfan, melphalan and fludarabineExperimental Treatment5 Interventions
P-rATG days (Appendix A - always starting on Day -12 to -10) Busulfan -Day -9 to -7 Initial dose per table in Appendix B; doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg*h/L Melphalan (70mg/m2/day x 2 days) Day -6 to -5 Fludarabine (25mg/m2/day x 5 days) Day -6 to -2 GCSF Day +7
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Melphalan
2008
Completed Phase 3
~1500
GCSF
2009
Completed Phase 2
~350
Thiotepa
2008
Completed Phase 3
~2150

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,319 Total Patients Enrolled
Kevin Curran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Personalized rATG (P-rATG) (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04872595 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: P-rATG with total body irradiation, thiotepa, cyclophosphamide, P-rATG with busulfan, melphalan and fludarabine
Acute Lymphoblastic Leukemia Clinical Trial 2023: Personalized rATG (P-rATG) Highlights & Side Effects. Trial Name: NCT04872595 — Phase 2
Personalized rATG (P-rATG) (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04872595 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Personalized rATG (P-rATG)?

"Although there is limited evidence of P-rATG's efficacy, it has garnered a score of two due to the prior clinical data that supports its safety."

Answered by AI

Could you provide information on prior experiments related to Personalized rATG (P-rATG)?

"Presently, there are 967 active trials researching the efficacy of Personalized rATG (P-rATG). Of these studies, 171 have advanced to Phase 3. Philadelphia is home to the most research centers regarding P-rATG with 29720 other locations hosting clinical trial sites for this medication."

Answered by AI

How many individuals have been selected to participate in this investigation?

"Affirmative. According to the available information on clinicaltrials.gov, this medical trial is still accepting participants as of today's date. It was first posted back on April 30th 2021 and has been updated most recently on August 31st 2022. The research initiative requires 56 volunteers at a single site for completion."

Answered by AI

Does this investigation still accept enrollees?

"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants and was initially publicized on April 30th 2021. The most recent update was provided August 31st 2022. 56 volunteers need to be recruited at a single site for the study's completion."

Answered by AI

For what conditions is Personalized rATG (P-rATG) commonly prescribed?

"Personalized rATG (P-rATG) is regularly prescribed to patients with multiple sclerosis and can be helpful in managing various ailments such as acute myelocytic leukemia, chronic myelogenous leukemia, thrombocythemia, essential, and allogeneic hematopoietic stem cell transplants."

Answered by AI
~15 spots leftby Apr 2025