High Dose Chemotherapy and Stem Cells for Peripheral T-Cell Lymphoma

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

Recruiting Phase 3 Interventional Study
Anaplastic Large Cell Lymphoma, ALK-Negative Follicular Helper T-Cell Lymphoma Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type Peripheral T-Cell Lymphoma, Not Otherwise Specified
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
294 (estimated)
Sponsor
Eastern Cooperative Oncology Group · Research network
Who this trial is looking for

This trial is looking for patients with a type of lymphoma called peripheral T-cell lymphoma who have responded well to initial chemotherapy. If you join, you may receive high dose chemotherapy followed by your own stem cells to see if this treatment helps improve survival compared to just being monitored after chemotherapy.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with peripheral T-cell lymphoma.
  • I achieved complete remission after initial chemotherapy.
  • I am ready for a stem cell transplant if chosen for that part of the study.
  • I have a normal level of certain blood cells and liver function tests.
  • I have no active infections at the time of joining.
  • I am not pregnant or breastfeeding.
  • I do not expect to conceive during and after the study.

You may not be able to join if

  • I have an active infection requiring intravenous antibiotics.
  • I am currently pregnant or breastfeeding.
  • I have had a previous or current cancer that could interfere with the study.
  • I have not achieved complete remission after induction therapy.
  • I am not able to undergo high dose chemotherapy or stem cell transplant.
  • I have not been treated for hepatitis C if I had an infection.
  • I have a history of hepatitis B virus infection without undetectable viral load.
  • I have not maintained stable contraception during the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not kno…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories: * Anaplastic large cell lymphoma (AL…
Contacts

Pamela Cogliano

857-504-2900

ecog.rss@jimmy.harvard.edu

CONTACT