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Bruton's Tyrosine Kinase (BTK) Inhibitor

Autologous HSCT for Non-Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Krish Patel, MD
Research Sponsored by Swedish Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transformation from prior indolent NHL is permitted
Expected life expectancy of at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining a chemotherapy drug with a new immunotherapy drug, to see if it is more effective than chemotherapy alone, and if it has fewer side effects.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you had a slow-growing type of cancer before, you can still participate in the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 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
Cohort A: Complete Response Rate
Cohort B: Progression Free Survival
Secondary outcome measures
Cohort A: Treatment Response
Cohort B: Treatment Completion
Other outcome measures
Cohorts A and B: Incidence of Serious Adverse Events
Cohorts A and B: Incidence of treatment-related Grade 3 and 4 Adverse events as assessed by CTCAE v4.0
Cohorts A and B: Overall Response Rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Transplant ineligibleExperimental Treatment5 Interventions
Patients receive RICE chemoimmunotherapy + Acalabrutinib Salvage therapy: RICE: Rituximab 375mg/m2 IV d1, Ifosfamide 5000mg/m2, Carboplatin AUC 5 IV d2, Etoposide 100mg/m2 IV d1-3. Acalabrutinib 100mg oral BID d1-21. Cycle is 21 days for up to 3 cycles of treatment. Maintenance therapy: Patients will receive Acalabrutinib 100mg oral BID for 12 consecutive months or until progression or intolerance if occurs within those 12 months. Maintenance therapy will only be given to patients with stable disease or better response after 3 cycles of RICE+ acalabrutinib
Group II: Cohort A: Transplant eligibleExperimental Treatment9 Interventions
Patients receive RICE: Rituximab 375mg/m2 IV d1, Ifosfamide 5000mg/m2, Carboplatin area under curve (AUC) 5 IV d2, Etoposide (VP16) 100mg/m2 IV d1-3 & Acalabrutinib 100mg oral BID d1-21. Cycle is 21 days for up to 3 cycles of treatment. BEAM chemotherapy & autoHSCT: BEAM given as Carmustine (BCNU) 300mg/m2 IV day -6 respective to stem cell infusion, VP16 200mg/m2 IV BID day -5 to day-2, Cytarabine (Ara-C) 200mg/m2 IV BID day -5 to day -2, and Melphalan 140mg/m2 IV day -1. Autologous hematopoietic stem cell infusion on day 0. Only patients with CR/PR after RICE acalabrutinib will undergo BEAM and autoHSCT Maintenance therapy: Post autoHSCT patients will receive Acalabrutinib 100mg oral BID starting on day +30 for 12 consecutive months or until progression or intolerance if occurs within those 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Ifosfamide
2010
Completed Phase 4
~2980
Etoposide
2010
Completed Phase 3
~2440
Rituximab
1999
Completed Phase 4
~1880
Carmustine
1990
Completed Phase 3
~1790
Cytarabine
2016
Completed Phase 3
~3310
Melphalan
2008
Completed Phase 3
~1500
Acalabrutinib
2020
Completed Phase 2
~2030

Find a Location

Who is running the clinical trial?

Swedish Medical CenterLead Sponsor
53 Previous Clinical Trials
8,248 Total Patients Enrolled
Acerta Pharma BVIndustry Sponsor
45 Previous Clinical Trials
5,878 Total Patients Enrolled
Krish Patel, MDPrincipal InvestigatorSwedish Medical Center
1 Previous Clinical Trials
2 Total Patients Enrolled

Frequently Asked Questions

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

What are the Federal Drug Administration's thoughts on Autologous HSCT?

"Autologous HSCT is a Phase 2 clinical trial, meaning that while there is some data supporting safety, there is no existing evidence for efficacy. Our team has rated the safety at a 2."

Answered by AI

Are there any available openings for people who want to participate in this research?

"This information is available on clinicaltrials.gov. The trial was posted on 8/16/2019 and last updated on 7/20/2022, indicating that it is actively seeking patients."

Answered by AI

What other research studies have used Autologous HSCT?

"As of now, there are 1597 clinical trials ongoing for Autologous HSCT. 422 out of the total number of active clinical trials are in their third stage. Most trials for Autologous HSCT take place in Shanghai but there are a grand total 74423 locations running these sorts of tests worldwide."

Answered by AI

What are some of the conditions that Autologous HSCT has been shown to help?

"Autologous HSCT is a treatment option for patients with newly diagnosed cancer as well as those who are struggling with prostate cancer, small cell lung cancer (sclc), or advanced testicular cancer."

Answered by AI

How many people have agreed to participate in this research project?

"That is correct, the online clinical trials registry does show that this study is open for recruitment. This trial was first made public on August 16th, 2019 and was most recently updated on July 20th, 2022. The aim of the study is to enroll 47 individuals at a single site."

Answered by AI

Are geriatric patients welcome in this clinical trial?

"This clinical trial is only for patients aged 18 to 75. If you search the database for trials with an age limit of under 18, 305 results come up. For trials with an upper age limit of over 65, 1,741 different options are available."

Answered by AI

Might I be a good candidate for this research project?

"According to the requirements listed, patients must have a diffuse large b-cell lymphoma (dlbcl), be between 18 and 75 years old to be eligible for this trial, of which there are only 47 spots available."

Answered by AI
~8 spots leftby Mar 2025