ACTIVE_NOT_RECRUITING

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaDiffuse Large B-cell LymphomaAcute Lymphoblastic LeukemiaLarge B-cell LymphomaCAR-TIbrutinibCLLDLBCLALLBLRMYTB323Rapcabtagene autoleucel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

Official Title

Phase I/II, Open Label, Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

Quick Facts

Study Start:2019-06-26
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03960840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG performance status 0-1 for ALL and DLBCL
  2. * ECOG performance status 0-2 for 1L HR LBCL at screening
  3. * CLL or SLL diagnosis according to iwCLL criteria
  4. * CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
  5. * DLBCL diagnosis by local histopathology
  6. * DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
  7. * Refractory or relapsed CD19-positive ALL
  8. * ALL with morphologic disease in the bone marrow
  9. * IPI score of 3, 4 or 5
  10. * MYC and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma)
  11. * Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent) DA-EPOCH-R.
  12. * Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial.
  1. * Prior CD19-directed therapy
  2. * Prior administration of a genetically engineered cellular product
  3. * Prior allogeneic HSCT
  4. * Richter's transformation
  5. * For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS.
  6. * Active CNS lymphoma
  7. * For 1L HR LBCL: Active or prior history CNS involvement by malignancy
  8. * Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

University of California LA
Los Angeles, California, 90095
United States
Stanford University Medical Center
Stanford, California, 94305-5826
United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northwestern University Northwestern Memorial Hospital Trans
Chicago, Illinois, 60611
United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, 60637
United States
University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Mass Gen Hosp Cancer Center
Boston, Massachusetts, 02114
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
University of Pennsylvania Clinical
Philadelphia, Pennsylvania, 19104
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37221
United States
St Davids South Austin Medical Ctr
Austin, Texas, 78704
United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-26
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2019-06-26
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • CAR-T
  • Ibrutinib
  • CLL
  • DLBCL
  • ALL
  • BLRM
  • YTB323
  • Rapcabtagene autoleucel

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Acute Lymphoblastic Leukemia
  • Large B-cell Lymphoma