294 Participants NeededMy employer runs this trial

High Dose Chemotherapy + Stem Cell Transplant for T-Cell Lymphoma

Recruiting at 164 trial locations
PC
Overseen ByPamela Cogliano
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eastern Cooperative Oncology Group
Must be taking: Anthracycline chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high-dose chemotherapy followed by a stem cell transplant is more effective than observation alone for individuals with peripheral T-cell lymphoma who have responded well to initial treatment. The researchers aim to determine if this combination kills more cancer cells and aids recovery by replacing damaged blood-forming cells. It suits those who have achieved complete remission after chemotherapy for specific types of T-cell lymphoma. Participants should be prepared for a stem cell transplant if assigned to that group. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antibiotics, the dose must be stable for at least 7 days before randomization.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-dose chemotherapy followed by an autologous stem cell transplant (ASCT) is generally well-tolerated in patients with certain types of lymphoma. Studies have found that this treatment can improve long-term survival. For example, one study found that 47.6% of patients were alive five years after the treatment, and 43.5% did not experience major disease progression during that time. This indicates that nearly half of the patients lived for at least five years post-treatment, and a similar number did not see their disease worsen.

Regarding safety, while side effects can occur, they are usually manageable. Common side effects include nausea, fatigue, and infections, typical with high-dose chemotherapy. Serious complications are less common but can occur, so patients receive close monitoring. This treatment has been used for many years, and its safety is well-documented, providing reassurance to patients considering this option.12345

Why are researchers excited about this study treatment for T-cell lymphoma?

Researchers are excited about high dose chemotherapy combined with autologous stem cell transplant (ASCT) for T-cell lymphoma because this approach aims to tackle the cancer aggressively by first administering intense chemotherapy to eliminate cancer cells, and then replenishing the body's blood-forming cells through ASCT. Unlike standard lymphoma treatments, which typically involve lower doses of chemotherapy and radiation, this method utilizes a high dose of chemotherapy to maximize cancer cell destruction. The addition of ASCT helps to restore the patient's immune system more quickly and effectively, potentially leading to better outcomes. This approach offers a unique blend of aggressive treatment and rapid recovery support, setting it apart from conventional therapies.

What evidence suggests that high dose chemotherapy and autologous stem cell transplantation might be an effective treatment for peripheral T-cell lymphoma?

Research has shown that high-dose chemotherapy followed by a stem cell transplant from the patient's own body can effectively treat peripheral T-cell lymphoma. Studies have found that this method reduces the likelihood of cancer recurrence. Specifically, one study reported that 67% of patients remained cancer-free for an average of 6.5 years post-treatment. Another study found that 68.9% of patients survived after three years, with 53% experiencing no cancer progression. In this trial, some participants will receive high-dose chemotherapy followed by a stem cell transplant, while others will be in an observation group. These findings suggest that combining high-dose chemotherapy with a stem cell transplant may enhance long-term survival compared to monitoring the condition alone.16789

Who Is on the Research Team?

NN

Nabila N Bennani

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with certain types of T-cell lymphoma who have fully responded to initial chemotherapy. Participants must be healthy enough for high dose chemo and stem cell transplant, not pregnant or breastfeeding, and have good organ function. People with active infections or uncontrolled other cancers can't join.

Inclusion Criteria

Total bilirubin ≤ 1.5 x institutional upper limit of normal
AST/ALT ≤ 3.0 x institutional ULN
I am between 18 and 75 years old.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either standard of care observation or high dose chemotherapy followed by autologous stem cell transplant

Varies based on treatment arm
Multiple visits for chemotherapy and stem cell procedures

Follow-up

Participants are monitored for progression-free survival and overall survival

12 years
Every 3 months for 2 years, every 6 months for 3 years, then yearly

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation
  • High Dose Chemotherapy

Trial Overview

The study compares two approaches after successful initial treatment: one group gets high dose chemotherapy followed by a transplant using their own stem cells; the other group is just observed without further immediate treatment. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (high dose chemotherapy and ASCT)Experimental Treatment9 Interventions
Group II: Arm I (observation)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials
272
Recruited
153,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Long-term effectiveness and safety of high dose ... - PMC - NIH

We retrospectively evaluated long-term outcomes of high dose chemotherapy followed by autologous stem cell transplant (HDC/ASCT) in patients with diffuse large ...

Outcomes of Autologous Stem Cell Transplantation in ...

Twenty (67%) remained disease-free, with a median event-free survival of 6.5 years. All 30 patients achieved either a complete (CR) or partial remission (PR) ...

Real-world data of long-term survival in patients with T-cell ...

Previous studies have shown that consolidative up-front high-dose chemotherapy followed by autologous-SCT (auto-SCT) reduces relapse rate and ...

Outcome of High-Dose Chemotherapy Followed by ... - PMC

Consistently, overall survival and progression-free survival did not differ among the two groups: 3-year overall survival was 91% and 89% (p = ...

Outcomes of Autologous Stem Cell Transplantation in ...

Twenty (67%) remained disease-free, with a median event-free survival of 6.5 years. All 30 patients achieved either a complete (CR) or partial remission (PR) ...

Real World Data on Efficacy and Safety of EPOCH in T-Cell ...

At a potental median follow up of 14.4 years, the estimated event free survival (EFS) probabilities were 72% for ALK-positive and 62.5% for ALK-negative ALCL.

Multicenter randomized phase III study of high-dose therapy ...

PTCL prognosis, especially in the advanced stage, is unfavorable, with a 5-year overall survival (OS) of 32% for PTCL-NOS and a 5-year OS of 32% ...

Fate Therapeutics Announces Clinical Safety and Activity ...

2 of 6 patients previously treated with CAR T-cell therapy achieved an objective response (1 CR, 1 PR) at Day 30, which included a complete ...

High-dose extended-field radiotherapy plus chemotherapy ...

This study aims to report clinical characteristics, prognostic factors, and outcomes in a multicenter cohort of ENKTL patients from Brazil.