Skip to content
Triangle logo TriangleGet started
← Study library

NCT01318317 · REGISTRY CONDITION SEARCH

Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-05-05

This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

→

outcome · POSTED

Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background

→

outcome · POSTED

Number of Days of Quantifiable CD19 CAR Post T-cell Infusion

→

outcome · POSTED

Failure to Engraft

→

outcome · POSTED

Progression-free Survival at 1 Year

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with history of intermediate grade B-cell NHL (e.g., diffuse B-cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma) * History of relapse after achieving first remission with primary therapy, or failure to achieve remission with primary therapy * Life expectancy \> 16 weeks * Karnofsky performance scale (KPS) \>= 70% * Negative serum pregnancy test for women of childbearing potential * Research participant has an indication to be considered for autologous stem cell transplantation Exclusion Criteria: * Fails to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study; evidence of understanding includes passing the Protocol Comprehensive Screening given by the Research Subject Advocate (RSA); a legal guardian may substitute for the research participant * Any standard contraindications to myeloablative HSCT per standard of care practices at COH * Dependence on corticosteroids * Currently enrolled in another investigational therapy protocol * Human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment * History of allogeneic HSCT or prior autologous HSCT * Active autoimmune disease requiring systemic immunosuppressive therapy * Research participant(s) who are to receive radioimmunotherapy (Zevalin-based)-based conditioning regimens * Research participant(s) with known active hepatitis B or C infection
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.
    intervention Names
    1. Procedure: Autologous Hematopoietic Stem Cell Transplantation
    2. Biological: Filgrastim
    3. Biological: Genetically Engineered Lymphocyte Therapy
    4. Other: Laboratory Biomarker Analysis
    5. Procedure: Peripheral Blood Stem Cell Transplantation
    6. Drug: Plerixafor
    7. Biological: Rituximab
    label
    Treatment (cellular adoptive immunotherapy following PBSCT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Undergo autologous PBSCT
    name
    Autologous Hematopoietic Stem Cell Transplantation
    other Names
    1. AHSCT
    2. Autologous
    3. Autologous Hematopoietic Cell Transplantation
    4. Autologous Stem Cell Transplant
    5. Autologous Stem Cell Transplantation
    6. Stem Cell Transplantation, Autologous
    type
    PROCEDURE
  2. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Given IV
    name
    Filgrastim
    other Names
    1. Filgrastim-aafi
    2. G-CSF
    3. Neupogen
    4. Nivestym
    5. r-metHuG-CSF
    6. Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    7. rG-CSF
    8. Tevagrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Receive ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR
    name
    Genetically Engineered Lymphocyte Therapy
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Undergo autologous PBSCT
    name
    Peripheral Blood Stem Cell Transplantation
    other Names
    1. PBPC transplantation
    2. PBSCT
    3. Peripheral Blood Progenitor Cell Transplantation
    4. PERIPHERAL BLOOD STEM CELL TRANSPLANT
    5. Peripheral Stem Cell Support
    6. Peripheral Stem Cell Transplant
    7. Peripheral Stem Cell Transplantation
    type
    PROCEDURE
  6. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Given IV
    name
    Plerixafor
    other Names
    1. AMD 3100
    2. JM-3100
    3. Mozobil
    4. SDZ SID 791
    type
    DRUG
  7. arm Group Labels
    1. Treatment (cellular adoptive immunotherapy following PBSCT)
    description
    Given IV
    name
    Rituximab
    other Names
    1. ABP 798
    2. BI 695500
    3. C2B8 Monoclonal Antibody
    4. Chimeric Anti-CD20 Antibody
    5. CT-P10
    6. IDEC-102
    7. IDEC-C2B8
    8. IDEC-C2B8 Monoclonal Antibody
    9. MabThera
    10. Monoclonal Antibody IDEC-C2B8
    11. PF-05280586
    12. Rituxan
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of DLTs per dose level are reported. A DLT is defined as: Any grade 3 or higher toxicity, with the exception of expected adverse events; and designated as definitely or probably related (level of attribution) to the infusion of the TCM cells; and occurring within 28 days of T-cell infusion; Any toxicity requiring the use of steroids to ablate side effects attributable to the infusion of the TCM cells, and occurring within 28 days of T-cell infusion; Any toxicity which is a lower grade, but that increases in grade to a grade 3 or higher as a direct result of the TCM, and occurring within 28 days of T-cell infusion; Any grade 2 or greater autoimmune toxicity, and occurring within 28 days of T-cell infusion.
    measure
    Number of Participants With Dose Limiting Toxicities (DLTs)
    time Frame
    Within 28 days of T-cell infusion
  2. description
    Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range
    measure
    Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background
    time Frame
    28 days post T cell infusion
  3. description
    WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
    measure
    Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
    time Frame
    28 days post T cell infusion
secondary Outcomes
  1. description
    Count of participants who fail to engraft post transplant.
    measure
    Failure to Engraft
    time Frame
    Within 21 days post T-cell infusion
  2. description
    Estimated using the Kaplan-Meier methods. Progression is defined using the revised IWG response criteria, as any new lesion or increase by ≥50% of previously involved sites from nadir.
    measure
    Progression-free Survival at 1 Year
    time Frame
    Up to 1 year
Full study description
brief Summary
This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.
detailed Description
PRIMARY OBJECTIVES: I. To assess the safety of cellular immunotherapy utilizing ex vivo expanded autologous central memory T cell (TCM)-enriched cluster of differentiation (CD)8+ T cells genetically-modified to express a CD19-specific chimeric antigen receptor (CAR) in conjunction with a standard myeloablative autologous hematopoietic stem cell transplantation (aHSCT) for research participants with high-risk intermediate grade B-lineage non-Hodgkin lymphomas who have relapsed after primary therapy, or who did not achieve complete remission with primary therapy. (Phase I) II. To determine the maximum tolerated dose (MTD) on dose limiting toxicities (DLTs) and to describe the full toxicity profile. (Phase I) III. To determine the rate of research participants receiving TCM-enriched CD8+ T cells genetically-modified to express a CD19-specific CAR for which the transferred cells are detected in the circulation 28 days (+/- 3 days) by woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) quantitative (Q)-polymerase chain reaction (PCR). (Phase II) SECONDARY OBJECTIVES: I. To determine the tempo, magnitude, and duration of engraftment of the transferred T cell product as it relates to the number of cells infused. (Phase II) II. To study the impact of this therapeutic intervention on the development of CD19+ B-cell precursors in the bone marrow as a surrogate for the in vivo effector function of transferred CD19-specific T cells. (Phase II) III. To describe the progression-free and overall survival of treated research participants on this protocol. (Phase II) OUTLINE: This is a phase I, dose-escalation study of genetically engineered lymphocyte therapy followed by a phase II study. Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with filgrastim and/or plerixafor. Some patients may also receive rituximab intravenously (IV) within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant. After completion of study treatment, patients are followed up periodically for at least 15 years.
Source references
references
  1. citation
    Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
    pmid
    34515338
    type
    DERIVED
  2. citation
    Wang X, Popplewell LL, Wagner JR, Naranjo A, Blanchard MS, Mott MR, Norris AP, Wong CW, Urak RZ, Chang WC, Khaled SK, Siddiqi T, Budde LE, Xu J, Chang B, Gidwaney N, Thomas SH, Cooper LJ, Riddell SR, Brown CE, Jensen MC, Forman SJ. Phase 1 studies of central memory-derived CD19 CAR T-cell therapy following autologous HSCT in patients with B-cell NHL. Blood. 2016 Jun 16;127(24):2980-90. doi: 10.1182/blood-2015-12-686725. Epub 2016 Apr 26.
    pmid
    27118452
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-154446896dca5fc84a70
      requested nct id
      NCT01318317
      primary nct id
      NCT01318317
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      d3c942affa9bd54ebe97f3f0e7012ccf5906026457fbe37e3056587a7dc1d4ff
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-154446896dca5fc84a70
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01318317
      occurrences
      1. context exact
        NCT01318317
        end
        11
        exact text
        NCT01318317
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/34/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      77cbfbd03dca6e46035a6f034d0dab6be974d1fc4776d05e52a5ce325a913321

    Preserved source evidence · Not medical advice