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Autologous Stem Cell Transplant + CAR T-Cell Therapy for B-Cell Lymphoma
Phase 1
Waitlist Available
Led By Craig Sauter, 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
- Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.
- Adequate pulmonary function as assessed by DLCO of ≥ 45% adjusted for hemoglobin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether it's safe to give patients their own immune cells after high-dose chemotherapy and autologous stem cell transplantation.
Who is the study for?
This trial is for adults over 18 with aggressive B-cell non-Hodgkin lymphoma who've relapsed or are not responding to treatment. They should have a life expectancy of more than 3 months, good kidney and liver function, no severe heart or lung issues, and no other cancers that could interfere with the study. Those previously treated with bone marrow or stem cell transplants, or those with uncontrolled infections including HIV and hepatitis B/C can't participate.Check my eligibility
What is being tested?
The trial tests high-dose chemotherapy followed by returning patients' own stem cells (ASCT) and then infusing their T-cells modified to target CD19+ B-cells (CAR-T therapy). It aims to see if this combination is safe for treating refractory/relapsed aggressive B-cell non-Hodgkin lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to immune cell infusion such as fever, fatigue, blood pressure changes; complications from high-dose chemotherapy like nausea, hair loss; risks associated with stem cell transplant including infection risk due to low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or is not responding to treatment, and I can't have a bone marrow transplant.
Select...
My lung function is good, as shown by a specific breathing test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum tolerated dose (MTD)
safety
Secondary outcome measures
2 year progression-free (PFS)
overall survival (os)
Side effects data
From 2020 Phase 1 & 2 trial • 34 Patients • NCT020592396%
Febrile Neutropenia
3%
Fever
3%
Tumor Lysis Syndrome
3%
Paroxysmal Atrial Tachycardia
3%
Syncope
3%
Heart Failure
3%
Pulmonary Hypertension
3%
Diarrhea
3%
Hypocalcemia
3%
Hypoxia
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine
Bendamustine Plus Autologous Transplantation
Bendamustine Plus Allogeneic Transplantation
Trial Design
1Treatment groups
Experimental Treatment
Group I: HIGH DOSE CHEMOTHERAPY AND ASCTExperimental Treatment7 Interventions
This is a phase 1 dose escalation study designed to determine the maximum tolerated dose (MTD) of CAR modified T cells in patients with relapsed and refractory aggressive B-NHL. Three dose levels (5 x 106 19-28z T cells/kg, 1 x 107 19-28z T cells/kg, and 2 x 107 19-28z T cells/kg) are considered for the MTD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegfilgrastim
2013
Completed Phase 3
~4410
Carmustine
1990
Completed Phase 3
~1790
Etoposide
2010
Completed Phase 3
~2440
Cytarabine
2016
Completed Phase 3
~3310
Melphalan
2008
Completed Phase 3
~1500
Autologous Stem Cell Transplantation
2012
Completed Phase 3
~1000
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,865 Total Patients Enrolled
Craig Sauter, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
59 Total Patients Enrolled
Mark Geyer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is functioning well, with an LVEF greater than 40%.I have had cancer before, but it doesn't affect my current study participation.I am 18 or older with a type of aggressive B-cell lymphoma.My cancer responded to chemotherapy after radiotherapy, as shown by a PET scan.I have not had a bone marrow or stem cell transplant.I need assistance with my daily activities.I do not have any ongoing serious infections.My cancer has returned or is not responding to treatment, and I can't have a bone marrow transplant.My lung function is good, as shown by a specific breathing test.I have an aggressive B-cell cancer not listed in the main criteria.
Research Study Groups:
This trial has the following groups:- Group 1: HIGH DOSE CHEMOTHERAPY AND ASCT
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.
In what ailments has Autologous Stem Cell Transplantation typically proven beneficial?
"Autologous Stem Cell Transplantation is a viable medical intervention for individuals with newly-diagnosed high grade glioma (HGG), carcinomas, and gestational trophoblastic diseases."
Answered by AI
What is the aggregate of participants taking part in this experiment?
"This clinical trial is not accepting new patients at this time. It was first published on April 1st 2013 and recently underwent a few edits, with the last update occurring on April 7th 2022. Those who are looking for alternative trials related to lymphoma may find luck in one of the 1797 studies currently recruiting participants or 591 Autologous Stem Cell Transplantation experiments actively searching for volunteers."
Answered by AI
Could you elucidate on the safety profile of Autologous Stem Cell Transplantation?
"This clinical trial has limited data on efficacy and safety, so our team at Power have rated the Autologous Stem Cell Transplantation's safety as a 1."
Answered by AI
Are there still vacancies for participants in this investigation?
"Information revealed on clinicaltrials.gov reveals that this specific medical study is no longer recruiting, having been first posted April 1st 2013 and last updated on the 7th of April 2022. Nonetheless, there are a multitude of other trials in need of participants at present; 2388 to be exact."
Answered by AI
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