294 Participants NeededMy employer runs this trial

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

PC
Overseen ByPamela Cogliano
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eastern Cooperative Oncology Group
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 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 known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

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?

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

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation
  • High Dose Chemotherapy

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+