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Protein

ASC-101 Enhanced Cord Blood Transplant for Blood Cancers

Q: Are there numerous healthcare facilities executing this clinical experiment in North America?

Patients can enrol in this study at the <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Institute (San Antonio), University Hospitals of Cleveland, M.D. Anderson <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center (Houston), and 4 other medical centres across the country.

Q: What medical condition are Fludarabine, Melphalan, ATG (Reduced Intensity) typically prescribed for?

Fludarabine, Melphalan, ATG (Reduced Intensity) is typically used to treat hematopoietic stem cells. Moreover, this medication has proven effective in treating leukemias langerhans cell histiocytosis and DLBCLs.

Q: Have any prior investigations explored the effects of Fludarabine, Melphalan and ATG (Reduced Intensity) on patients?

Fludarabine, Melphalan, ATG (Reduced Intensity) was first explored in 1993 at the National Institutes of Health Clinical Center. Since then, 1940 trials have concluded their course and 962 are presently recruiting patients; notably a sizable number of these studies occur out of San Antonio in <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>.

Q: What is the cap on enrolment for this research?

This particular trial is no longer accepting patients. It was first posted on November 1st 2013 and last updated two weeks later, on the 14th. For those seeking alternative trials that may be more suitable for their needs, there are currently 4323 trials recruiting participants with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> as well as 962 studies using Fludarabine, Melphalan, ATG (Reduced Intensity).

Q: Is participation in this trial accessible to minors?

Eligibility for this research requires individuals to be in the age range of 1 year to 80 years old. Subsequently, there are 1266 trials available for minors and 4353 studies that cater towards elderly patients.

Q: Is there still an opportunity for new volunteers to enroll in this research?

At this time, the trial is not taking new applicants. It was first posted on November 1st 2013 and had its last update two weeks later. For those searching for other medical studies, there are 4323 clinical trials currently recruiting patients with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and 962 active trials involving Fludarabine, Melphalan &#x26; ATG (Reduced Intensity).

Phase 1 & 2

Waitlist Available

Research Sponsored by Targazyme, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pulmonary function test (PFT) demonstrating diffusion capacity of lung for carbon monoxide (DLCO) ≥ 50% of predicted. For children < 7 years of age who are unable to perform PFT, oxygen saturation > 92% on room air by pulse oximetry allowed.

Patients with ALL: CR1 with Philadelphia chromosome or translocation 4;11, hypodiploidy, and/or persistent minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy, CR2 or CR3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

Study Summary

This trial is for leukemia, lymphoma or myelodysplastic syndrome patients who will receive cord blood that has been changed in the laboratory to add sugar. The goal is to see if it is safe and if the cord blood cells find their way to the bone marrow faster.

Who is the study for?

This trial is for people aged 1-80 with certain blood cancers or bone marrow disorders, who haven't found a perfect donor match. They must be in specific stages of their disease and have functioning major organs. Pregnant women, those with HIV/HBV/HCV, or recent investigational drug use are excluded.Check my eligibility

What is being tested?

Researchers are testing if altering cord blood cells before transplant can help them reach the bone marrow quicker and improve outcomes for patients with leukemia, lymphoma, or myelodysplastic syndrome. The study involves 'conditioning' chemo treatment to prepare the body for transplant.See study design

What are the potential side effects?

Possible side effects include immune system reactions from ATG protein, damage to DNA by chemotherapy drugs like Fludarabine and Busulfan which may cause cancer cells to die but also affect healthy cells leading to various side effects such as nausea and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung function test shows I can breathe well enough, or if I'm under 7, my oxygen level is good without extra help.

Select...

My leukemia is in remission but has specific genetic features or is a result of past treatment.

Select...

My Hodgkin's disease is in its second or third complete remission, or it has relapsed, including after a stem cell transplant.

Select...

My NHL is in its second or third complete remission, or it has relapsed.

Select...

I have two umbilical cord blood units that match my HLA type and meet the minimum cell count required.

Select...

My MDS is moderate to severe and previous treatments didn't work.

Select...

My CML is in the second chronic or accelerated phase after not responding well to previous treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability in patients who receive ASC-101-treated dual-cord UCBT

Secondary outcome measures

Preliminary efficacy of ASC-101-treated dual-cord UCBT, as assessed by the rate of reconstitution of neutrophils and platelets as compared to historical controls receiving an unmanipulated dual-cord UCBT

Trial Design

2Treatment groups

Experimental Treatment

Group I: Fludarabine, Melphalan, ATG (Reduced Intensity)Experimental Treatment1 Intervention

Day Treatment Day0 Admit, hydration Day1 Fludarabine 40 mg/m2 IV Day2 Fludarabine 40 mg/m2 IV, rabbit ATG 1.25 mg/kg Day3 Fludarabine 40 mg/m2 IV, rabbit ATG 1.75 mg/kg Day4 Fludarabine 40 mg/m2 IV and Melphalan 140 mg/m2 IV Day5 Rest Day6 Cord blood infusions

Group II: Fludarabine, Clofarabine, Busulfan, ATG, TBI (Myeloablative)Experimental Treatment1 Intervention

Fludarabine, Clofarabine, Busulfan, Anti-thymocyte Globulin (ATG), Total Body Irradiation (TBI) (Myeloablative) Day Treatment Day0 Admit, IV hydration, rituximab 375 mg/m2 (B cell malignancy) Day 1 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 Day2 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 Day3 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 Day4 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000, rabbit ATG 1.25 mg/kg Day5 Low-dose TBI 2 Gy in AM, rabbit ATG 1.75 mg/kg Day6 Rest Day7 Rest Day8 Cord blood infusions

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Targazyme, Inc.Lead Sponsor

Elizabeth Shpall, MDStudy ChairM.D. Anderson Cancer Center

5 Previous Clinical Trials

250,211 Total Patients Enrolled

Media Library

ATG (Protein) Clinical Trial Eligibility Overview. Trial Name: NCT01983761 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Fludarabine, Clofarabine, Busulfan, ATG, TBI (Myeloablative), Fludarabine, Melphalan, ATG (Reduced Intensity)

Non-Hodgkin's Lymphoma Clinical Trial 2023: ATG Highlights & Side Effects. Trial Name: NCT01983761 — Phase 1 & 2

ATG (Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01983761 — Phase 1 & 2

Frequently Asked Questions

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

Am I eligible to join this clinical research study?

"This trial is recruiting 25 individuals, ranging from born infants to octogenarians. To be eligible for the study, potential participants must not only have lymphoma but also fulfill additional criteria such as KPS of 80 or ECOG < 3 (age 12 years) or Lansky Play Performance Score of > 60% (age < 12 years). Furthermore, a backup cell source needs to be identified in case engraftment fails; this may stem from autologous sources or allogeneic ones (related and unrelated). A pediatrician's judgement will ultimately determine eligibility for minors."

Answered by AI

Are there numerous healthcare facilities executing this clinical experiment in North America?

"Patients can enrol in this study at the Texas Transplant Institute (San Antonio), University Hospitals of Cleveland, M.D. Anderson Cancer Center (Houston), and 4 other medical centres across the country."

Answered by AI

What medical condition are Fludarabine, Melphalan, ATG (Reduced Intensity) typically prescribed for?

"Fludarabine, Melphalan, ATG (Reduced Intensity) is typically used to treat hematopoietic stem cells. Moreover, this medication has proven effective in treating leukemias langerhans cell histiocytosis and DLBCLs."

Answered by AI

Have any prior investigations explored the effects of Fludarabine, Melphalan and ATG (Reduced Intensity) on patients?

"Fludarabine, Melphalan, ATG (Reduced Intensity) was first explored in 1993 at the National Institutes of Health Clinical Center. Since then, 1940 trials have concluded their course and 962 are presently recruiting patients; notably a sizable number of these studies occur out of San Antonio in Texas."

Answered by AI

What is the cap on enrolment for this research?

"This particular trial is no longer accepting patients. It was first posted on November 1st 2013 and last updated two weeks later, on the 14th. For those seeking alternative trials that may be more suitable for their needs, there are currently 4323 trials recruiting participants with lymphoma as well as 962 studies using Fludarabine, Melphalan, ATG (Reduced Intensity)."

Answered by AI

Is participation in this trial accessible to minors?

"Eligibility for this research requires individuals to be in the age range of 1 year to 80 years old. Subsequently, there are 1266 trials available for minors and 4353 studies that cater towards elderly patients."

Answered by AI

Is there still an opportunity for new volunteers to enroll in this research?

"At this time, the trial is not taking new applicants. It was first posted on November 1st 2013 and had its last update two weeks later. For those searching for other medical studies, there are 4323 clinical trials currently recruiting patients with lymphoma and 962 active trials involving Fludarabine, Melphalan & ATG (Reduced Intensity)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation

2013. "Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01983761.

All > Leukemia > Lymphoma