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Protein
ASC-101 Enhanced Cord Blood Transplant for Blood Cancers
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
Must not have
Active central nervous system (CNS) disease in patients with a history of CNS malignancy
Active, uncontrolled infection, decompensated congestive heart failure or pulmonary insufficiency requiring oxygen supplementation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active brain or spinal cord cancer.
Select...
I do not have an active infection, heart failure, or lung problems needing extra oxygen.
Select...
I have had a transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability in patients who receive ASC-101-treated dual-cord UCBT
Secondary study objectives
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
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
3 Trials studying Leukemia
136 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 1 and 80 years old.I am a woman who can have children, not sterilized, and willing to use birth control for the study.I have been diagnosed with a type of blood cancer.I have a perfect match donor for my transplant.My lung function test shows I can breathe well enough, or if I'm under 7, my oxygen level is good without extra help.You have received any experimental medication within the past 28 days before the screening.I have AML in remission but at high risk of coming back or it came from another cancer.My leukemia is in remission but has specific genetic features or is a result of past treatment.I have active brain or spinal cord cancer.My Hodgkin's disease is in its second or third complete remission, or it has relapsed, including after a stem cell transplant.I am mostly active and can do most of my daily activities on my own.I do not have an active infection, heart failure, or lung problems needing extra oxygen.I have had a transplant from a donor.My NHL is in its second or third complete remission, or it has relapsed.I have two umbilical cord blood units that match my HLA type and meet the minimum cell count required.My MDS is moderate to severe and previous treatments didn't work.My CML is in the second chronic or accelerated phase after not responding well to previous treatments.I have a backup source of cells ready in case the first transplant doesn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Fludarabine, Clofarabine, Busulfan, ATG, TBI (Myeloablative)
- Group 2: Fludarabine, Melphalan, ATG (Reduced Intensity)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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