Chemotherapy Agents for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oregon Health and Science University, Portland, OR
Lymphoma+3 More
Chemotherapy Agents - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

See full description

Eligible Conditions

  • Lymphoma
  • Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Chemotherapy Agents will improve 4 primary outcomes and 19 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Predose (Day 0) and at multiple timepoints postdose (up to 60 months).

Month 60
Parts 1 and 2: AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007
Parts 1 and 2: Cmax - Maximum Observed Blood Concentration of TAK-007
Parts 1 and 2: Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007
Parts 1 and 2: Tmax - Time of First Occurrence of Cmax of TAK-007
Up to 24 months
Part 1 and Part 2: Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time
Percentage of Participants with B-cell Aplasia Before and After TAK-007 Administration
Percentage of Participants with Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Up to 60 months
Part 1 and Part 2: Complete Response (CR) per Investigator
Part 1 and Part 2: Duration of Response (DOR) per Investigator
Part 1 and Part 2: ORR per Investigator
Part 1 and Part 2: Progression-free Survival (PFS) per Investigator
Part 1: Number of Participants with Adverse Events (AEs)
Part 1: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Part 1: Number of Participants with Clinically Significant Changes in Vital Signs
Part 2: Complete Response (CR) Per IRC
Part 2: Duration of Response (DOR) per IRC
Part 2: Number of Participants with Adverse Events (AEs)
Part 2: Number of Participants with Clinically Significant Changes in Laboratory Parameters
Part 2: Number of Participants with Clinically Significant Changes in Vital Signs
Part 2: Overall Response Rate (ORR) per Independent Review Committee (IRC)
Part 2: Progression-free Survival (PFS) per IRC
Parts 1 and 2: Overall Survival (OS)
Percentage of Participants with Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

6 Treatment Groups

Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells
1 of 6
Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells
1 of 6
Part 2: Cohort 1- LBCL
1 of 6
Part 1: Dose Expansion: LBCL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK C...
1 of 6
Part 2: Cohort 2- iNHL
1 of 6
Part 1: Dose Expansion: iNHL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK C...
1 of 6
Experimental Treatment

This trial requires 242 total participants across 6 different treatment groups

This trial involves 6 different treatments. Chemotherapy Agents is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK CellsParticipants will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 200×10^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable natural killer (NK) cells, single-dose, intravenously, once on Day 0.
Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK CellsParticipants will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0.
Part 2: Cohort 1- LBCLParticipants with LBCL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.
Part 1: Dose Expansion: LBCL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK CellsParticipants with r/r Large B-cell Lymphoma (LBCL) will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0 to determine RP2D.
Part 2: Cohort 2- iNHLParticipants with iNHL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 at RP2D, intravenously, once on Day 0.
Part 1: Dose Expansion: iNHL: TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK CellsParticipants with r/r Indolent Non-Hodgkin Lymphoma (iNHL) will receive lymphodepleting chemotherapy per day intravenously followed by TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, single-dose, intravenously, once on Day 0 to determine RP2D.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 60 months for reporting.

Closest Location

Oregon Health and Science University - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have a life expectancy ≥12 weeks. show original
You have an ECOG performance status of 0 or 1. show original
a. LBCL, including the following subtypes defined by the World Health Organization (WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii. High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii. HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular lymphoma (FL) or marginal zone lymphoma (MZL).
v. T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii. Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix. Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal, extranodal, and splenic).
Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography -positive disease per the Lugano classification.
Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody (mAb) and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
Participants with iNHL must have received an anti-CD20 mAb and an alkylating agent (eg, bendamustine or cyclophosphamide).
Preinduction salvage chemotherapy and ASCT should be considered 1 therapy.
A chemotherapy regimen followed by consolidation/maintenance therapy should be considered 1 line of therapy with the preceding combination therapy show original
Single-agent anti-CD20 mAb therapy should not be considered a line of therapy.

Patient Q&A Section

Have there been any new discoveries for treating lymphoma, diffuse?

"There have been no breakthroughs for treating diffuse large B-cell lymphomas (DLBL) since the last update from the National Cancer Institute (NCI). Adult DLBL is generally diagnosed at its most advanced stage when it has metastasized to sites outside the thorax and abdomen. Treatments have improved survival rates for DLBL, but >50% of patients still do not survive 5 years after their initial diagnosis. The prognosis will vary depending upon the type of DLBL; however, patients with DLBCL treated according to current guidelines have significantly longer survival rates compared with those who did not receive therapy." - Anonymous Online Contributor

Unverified Answer

What does chemotherapy agents usually treat?

"On average, lymphoma patients receive six cycles of chemotherapy during one year. Findings from a recent study found differences between treatment options such as regimens used with different types and stages (I & II), different types of lymphomas (diffuse vs. non-diffuse), and different types of treatment methods (chemotherapy alone vs. combination therapies). The treatment regimen varies depending on how rapidly the patient's tumor grows and how fast they will develop complications from the disease. Chemotherapy agents sometimes treat the underlying cause of the disease; however, the disease can still occur even if the chemotherapy treatments are not specifically targetted at specific cancer cells. Cancer patients often receive multiple chemotherapy treatments because the effectiveness of each treatment is limited. Please see summary table below." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma, diffuse spread?

"The prognosis is not good for patients with newly diagnosed DLBCL, regardless of age. However, in this population, age may play an important role in survival." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, diffuse?

"Although there may be variations between the data sources, these data suggest that about half of the patients have received one of the following regimens for current or previous relapses of DLBCL, FL, NHL, or 1012PLL. Patients who did not receive any therapy tended to have more aggressive disease characteristics. This suggests that evolution of DLBCL and NHL was slower in comparison to 1012PLL. Patients who were treated with two or more lines of chemotherapy had significantly higher survival rates compared to patients who only received one line of chemotherapy." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma, diffuse be?

"Newly diagnosed diffuse large B-cell lymphoma is an aggressive and highly lethal disease. Given its rarity, aggressive multimodality therapy may not be possible. A small portion of patients respond well to chemotherapy alone, so prospective evaluation of this strategy is warranted. It remains unclear whether combined modality therapy provides any benefit." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma, diffuse?

"The median survivals for DLBCL and FL are three and two years respectively. Survival rates were comparable between the two groups. Lymphoma, diffuse, is a chronic disease with long term consequences." - Anonymous Online Contributor

Unverified Answer

Is chemotherapy agents safe for people?

"In a recent study, patients receiving chemotherapy were at similar risk of neutropenic fever compared to those not receiving chemotherapy. This finding suggests that there is no evidence supporting the hypothesis that chemotherapy causes morbidity due to infection. There was no demonstrable difference in the incidence of serious infection between patients who received chemotherapy and patients who did not receive chemotherapy." - Anonymous Online Contributor

Unverified Answer

Is chemotherapy agents typically used in combination with any other treatments?

"The authors' conclusions are that chemotherapy agents are frequently used as single agents and in combination with radiation in relapsed aggressive lymphomas. Agents commonly used in combination with chemotherapy include cyclophosphamide (Cyclo), doxorubicin (Adriamycin), vincristine (Oncovin), and prednisone. Agents commonly used in combination with radiation include chlorambucil (Leukeran), cytarabine (Ara-C), melphalan (Melf), methotrexate (MTX), and prednisolone. A greater understanding of the role of chemotherapy or agents added to radiation alone may help doctors treat cancer patients more effectively." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of chemotherapy agents?

"Patients treated with chemotherapeutic agents commonly experience nausea, vomiting, diarrhea, fatigue, hair loss, oral mucositis, neutropenia, and mucocutaneous toxicity. Severe mucositis may result in anorexia, weight loss, and teratogenic complications. The majority of chemotherapeutic agents cause moderate to severe dermatitis, and this is more common with platinum-based compounds. Dermatitis is caused by immune-mediated mechanisms, not by direct cytotoxicity." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma, diffuse?

"Patients with non-Hodgkin's lymphoma have a very poor prognosis. However, patients with diffuse large B cell lymphoma (DLBCL) have an excellent response to therapy. The majority of DLBCL patients will respond to chemotherapy. There is currently no known biomarker that predicts response to chemotherapy in DLBCL. Thus, there is little rationale to exclude patients who may benefit from clinical trials for DLBCL." - Anonymous Online Contributor

Unverified Answer

What is chemotherapy agents?

"From the beginning of clinical trials on HDAC inhibitors, it is clear that HDACIs are active against both Hodgkin's lymphoma and DLBCL. The ultimate goal of treating Hodgkin's lymphoma with HDACIs is to achieve durable responses. Patients who have previously responded to HDACI therapy are unlikely to benefit from an additional cycle of chemotherapeutic regimens. In contrast, patients who have achieved a durable response with HDACI therapy should continue to receive HDACI therapy after they achieve complete remission. [Power] (http://www.withpower." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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